PGM

27th Annual EuroMeeting
Development, Innovation, Access and Patient Safety
13-15 April 2015

Palais des Congrs
Paris
Final Programme
DIA EuroMeeting 2015

13-15 April, Palais des Congrs, Paris
TABLE OF CONTENTS
Dear Colleagues,
Welcome Form DIA Chair, DIA Board of Directors and

DIA Global Chief Executive..........................................................................2
It is our pleasure to welcome you to Paris, the hub of European biotech

IPOs (international public offerings), and a city that boasts not only
centuries of science, but also the highest density of publically traded
biotech companies in Europe. Paris is a city that actively engages in
translating research into tangible economic realities with a robust
regulatory framework.
Thank you for joining us at DIAs 27th Annual EuroMeeting. As
we come together to share our collective knowledge to address
significant challenges in human health, we will reflect on our collective
accomplishments in Advancing Innovation to Combat the Global Burden
of Disease, the theme of the Opening Plenary. Our two keynote speakers,
Olivier Charmeil, Executive Vice President, Sanofi Vaccines, and Andrew
Morris, Professor, University of Edinburgh, and of the Farr Institute, will
address this subject in view of the need for pharmaceutical innovation.
Their focus will be centered on making innovation more efficient and
relevant through the use of big data.
This EuroMeeting brings together innovators and leaders from all parts
of the health care ecosystem. Our scientific offerings are organised
into themes and led by experts who will cover a wide range of interest
areas, such as access to innovative treatments, advanced therapies,
special development pathways, and pharmacovigilance, as well as glocal
outlook, collaborative consortia, and dialogue between regulators and
HTA bodies to advance translational medicine.
Welcome from the EuroMeeting 2015 Co-Chairs

& Programme Advisors.................................................................................3
EuroMeeting 2015 Theme Leaders....................................................................4
Schedule at a glance..............................................................................................5
General Information A-Z...................................................................................6-7
Award Winners........................................................................................................9
Professional Posters............................................................................................. 10
Student Posters / Patient Advocates.............................................................. 11
EuroMeeting Pre-Conference Optional Tutorials...................................16-18
Clinical Forum Pre-Conference Optional Tutorials..................................... 19
HAS Satellite Symposium.................................................................................. 20
50th Anniversary of the EU Parmaceutical Legislation........................... 20
50 Years of EDQM............................................................................................... 20
Opening Plenary................................................................................................... 21
Theme 1 | New R&D models and innovative clinical trial
methodologies. ..................................................................................... 22-23
Theme 2 | Medical Devices and Combination Products..................... 24-25
Also this DIA 27th EuroMeeting will celebrate the 50th anniversary of
the European Pharmaceutical Legislation as well as the 50th anniversary
of the EDQM (European Directorate for the Quality of Medicines and
Health Care). We will highlight the achievements of these landmark
organisations and provide a perspective into what can be expected in
the future for health care product development and regulation. Together
with DIAs recent 50th anniversary milestone, this EuroMeeting marks
an important milestone in our efforts to foster innovation by providing
forums for industry, regulators, patients, and other stakeholders to
exchange information and discuss health products, technologies,
services, and related issues in order to advance our collective mission
of developing and delivering effective therapies to patients worldwide.
Theme 3 | Advanced Therapies, Novel Treatments

for Rare Diseases................................................................................... 25-27
On behalf of the DIA Board of Directors and all of our EuroMeeting

programme volunteers, exhibitors, poster presenters, and staff, thank
you very much for attending our celebratory DIA 2015 27th EuroMeeting.
Theme 8 | Translational Medicine and Regulatory Science............... 35-37
Theme 4 | Early Dialogue with Regulators and

HTA Bodies on Innovative Medicines............................................... 27-28
Theme 5 | Collaborative Consortia, IMI and
the Way to Horizon 2020....................................................................29-30
Theme 6 | Implementing Innovation Globally
Conducive Regulatory Policies........................................................... 31-32
Theme 7 | Special Development Pathways in Paediatrics,
the Elderly and in Pregnancy.............................................................33-34
Theme 9 | Big Data, Mobile Health........................................................... 37-39

Theme 10 | Innovation in Vaccine Development...................................39-41
Enjoy the programme!
Theme 11 | Availability of Medicinal Products: Drug shortages.........41-42

Theme 12 | Pharmacovigilance in 2015 - Poised for
convergence of innovation..................................................................43-45
Hot Topics and Stand-Alone Sessions........................................................... 46
Focus Sessions..................................................................................................... 47
Per Spindler
Chair, DIA Board of Directors
Barbara Lopez Kunz

Global Chief Executive
Speaker Index.................................................................................................48-53
Networking Events ............................................................................................. 54
EuroMeeting Session Plan...........................................................................56-58

WELCOME FROM THE EUROMEETING 2015 CO-CHAIRS

Dear Colleagues,
We are delighted that the 27th Annual DIA EuroMeeting is held in Paris this year.
Our meeting comes at an exciting and challenging time for healthcare innovation. The demand for new therapies and new solutions has
never been higher, and the pace of innovation is increasing to meet these needs. This makes Paris an ideal choice for the venue. The city
has been at the forefront of scientific developments since the foundation of the Acadmie des Sciences in 1666. Since then, Paris-based
scientists have brought us stethoscopes and hypodermic needles, antibiotics and antipsychotics, vaccines against TB and rabies and have
successfully identified HIV. Now, in 2014, Paris remains pivotal in healthcare research, as the hub for Biotech IPOs in Europe.
If European companies are to remain competitive, they need a regulatory environment that supports their investment. The current rate
of innovation, with new approaches and innovative therapies are testing the limits of the existing system, presents its own challenges for
regulators and policymakers. Addressing these will require a collaborative approach between all stakeholders to create a streamlined,
harmonised approach to regulation. A future regulatory system should be capable of anticipating potential hurdles and barriers, allowing
the fruits of research to reach those people who need them more quickly. This will offer an impetus to companies to continue to invest in
research. In addition, it will add momentum to the kind of public-private partnership such as the Innovative Medicines Initiative capable
of accelerating effective drug development.
Adaptive pathways approvals, also named Adaptive Licensing or Medicine Adaptive Pathways to Patients, as prospectively planned adaptive
approach the regulation of drugs, is without any doubt one of the relevant method to accelerate access to innovative medicines. While
it is particularly relevant for medicines to treat serious conditions with unmet medical needs, it should also help developing innovative
regulatory strategies for all new drugs and vaccines.
The Annual DIA EuroMeeting provides the ideal opportunity to build the type of collaboration that will underpin future innovation in Europe.
An intense 3-day programme will present high quality information and discussion, along with opportunities for face-to-face meetings and
professional networking between all the main stakeholders. Participants can exchange knowledge and build the kind of partnerships that
will support innovation in drug development and address todays health challenges.
The DIA EuroMeeting 2015 should be the "go to" meeting for all professionals in drug discovery, drug development and regulation. We will
be able to add a little more to the reputation of Paris as a city of health innovation. We look forward to seeing you here.
Lidia Retkowska-Mika and Olivier Charmeil
PROGRAMME CO-CHAIRS
Lidia Retkowska-Mika
Director, Legal Department,
Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products, Poland
Olivier Charmeil
Executive Vice President Vaccines,
Sanofi, France
PROGRAMME ADVISORS
Martin Harvey Allchurch
Head of Communication, European Medicines Agency, EU
Jan Geissler
Director, EUPATI, Belgium
Angelika Joos
Executive Director, Global Regulatory Policy, MSD (Europe) Inc., Belgium
Yves Juillet
Senior Vice-President, Industrie Sant, France
Spiros Vamvakas
European Medicines Agency, EU
Christa Wirthumer-Hoche
Head, Austrian Medicines and Medical Devices Agency (AGES), Austria

EUROMEETING 2015 THEME LEADERS
Sabine Atzor
Head of EU Regulatory Policies,
F. Hoffmann-La Roche,
Switzerland
Salah-Dine Chibout
Global Head Discovery &
Investigative Safety, Global Head
Preclinical Safety Therapeutic Areas,
Novartis Pharma, Novartis
Anna Cielik
Director Department of
Documentation Assessment,
Office for Registration of Medicinal
Products, Poland
Isabelle Clamou
Regulatory Affairs Director
EU Policy, Amgen, Belgium
Susanna Del Signore

Associate Vice-President Global
Regulatory Affairs, Head of Global
Regulatory Policy, Sanofi R&D,
France
Beln Escribano Romero

Head of Department,
Pharmaceutical Inspection and
Enforcement Department, Spanish
Medicines Agency (AEMPS), Spain
Zaide Frias
Head of Regulatory Affairs and Best
Evidence, Head of Human Medicines
Research and Development
Support (ad interim),
Sabina Hoekstra-van den Bosch

Global Regulations and Standards,
Philips Healthcare, the Netherlands
Paul Jansen
Global Head Medical Devices US,
Sanofi, USA
Jun Kitahara
International Liaison Officer
stationed in Swissmedic,
Pharmaceuticals and Medical
Devices Agency (PMDA), Japan
Maarten Lagendijk
Pharmacovigilance Coordinator,
Medicines Evaluation Board (MEB),
the Netherlands
Jordi Llinares Garcia

Head of Product Development
Scientific Support, European
Medicines Agency, EU
Henrik Kim Nielsen

Corporate Vice President,
Regulatory Affairs GLP-1 and
Obesity, Novo Nordisk, Denmark
Detlef Niese
Consultant, Dr. Niese Health Science
and Policy, Germany
Luca Pani
Director General, Italian Medicines
Agency (AIFA), Italy
Richard Pilsudski
Vice President Global Regulatory
Affairs, Sanofi Pasteur, France
Dorthe Poulsen
Chief Legal Adviser, EU-Coordinator,
Danish Health and Medicines
Authority (DKMA), Denmark
Fatiha Sadallah
Principal Scientific Manager,
Innovative Medicines Initiative (IMI),
Belgium
Paula Salmikangas
Chair CAT, Senior Researcher,
Finnish Medicines Agency (FIMEA),
Finland
Duane Schulthess
Managing Director, Vital
Tranformation, Belgium
Henk Schuring
Group Vice President Regulatory
Affairs - Europe, Genzyme Europe,
the Netherlands
Pr Tellner
EFPIA ICH Coordinator, Director
Regulatory Affairs, EFPIA, Belgium
Jan Willem van der Laan

Department of Pharmacology,
Toxicology and Biotechnology
(FTBB), Medicines Evaluation Board,
the Netherlands
Maria Grazia Zurlo

QPPV,
Pfizer, Italy

SCHEDULE AT-A-GLANCE

Sunday, 12 April 2015
12:30-13:00
Speed Networking
13:00-14:00
DIA Communities - Meet and Eat
Registration Hours:
14:00-15:30
Parallel Scientific Sessions - Session 3
14:00-19:30
Exhibitor Registration and Set-up
Choose from Parallel Sessions
14:00-18:00
Attendee and Speaker Registration*
14:00-15:30
Exhibition Guest Passes
Students and Young Professionals Welcome
15:15-16:00
Coffee Break in the Exhibition Hall
16:00-17:30
* Avoid the rush on Monday by picking up your badge and conference
17:30-18:30
Networking Reception in the Exhibition Hall
material on Sunday afternoon
17:45-18:15
Student Poster Award Ceremony at the DIA Booth
17:30-18:30
Reception
Monday, 13 April 2015
Wednesday, 15 April 2015
Registration Hours:
Registration Hours:
07:30-11:00
Exhibitor Registration and Set-up
08:00-17:30
08:00-18:00
Attendee, Speaker and Exhibitor Registration
Schedule:
Schedule:
08:00-09:00
Welcome Coffee
09:00-12:30
Pre-Conference Tutorials*
08:00-16:00
Exhibition Hall Open
10:30-11:00
Pre-Conference Tutorials Coffee Break
09:00-10:30
11:00-12:30
HAS Satellite Symposium
12:00-18:00
Conference and Exhibition Open
10:15-11:00
12:00-14:00
Lunch & Innovation Theatre Presentation in the
11:00-12:30
Exhibition Hall
13:30-15:00
Regulatory Town Hall Meeting
11:00-12:30
50 Years of EDQM Session
14:00-17:30
Optional Clinical Forum Tutorials*
12:00-14:00
15:00-16:00
Extended Refreshment Break in the Exhibition Hall
Exhibition Hall
16:00-17:45
Opening Plenary Session
14:00-15:30
18:00-20:30
Bienvenue Paris Reception
15:15-16:00
16:00-17:30
17:30
End of Conference
*Space is limited for Pre-Conference Tutorials, therefore pre-registration

is strongly recommended. Availability for onsite registration is not
guaranteed
Tuesday, 14 April 2015
Registration Hours:
08:00-18:30
Schedule:
08:00-09:00
Welcome Coffee in the Exhibition Hall
08:00-18:30
Exhibition Hall Open
09:00-10:30
10:15-11:00
11:00-12:30
12:00-14:00
Exhibition Hall

GENERAL INFORMATION A-Z

The 27th Annual EuroMeeting takes place at:
Le Palais des Congrs de Paris
2, Place de la Porte Maillot
75017 Paris France
Registration will be located on Level 3. The conference and exhibition will take
place on levels 2 and 3.
For the first time ever, the EuroMeeting is organised in parallel to another DIA
flagship meeting in Europe, the 8th Annual Clinical Forum. This will afford
delegates unparalleled opportunities to interact and network with qualified
professionals from throughout Europe and the world, and to meet a wealth of
exhibiting companies, all under one roof.
App
Download the Free DIA Global App Today.
The DIA Global App is designed to enhance your meeting experience and
provide valuable information in one place. Create your session agenda, network
with attendees and exhibitors, and connect to DIA resources, social media
channels, member communities, and more.
To download, search for DIA Global in your app store.
Access the EuroMeeting 2015 App:
Sign in with the email address you registered for the EuroMeeting 2015
Click on the Events Icon
Select 27th Annual DIA EuroMeeting 2015
You can find assistance at the DIA Booth #3.D17 on Level 3
Banking/ATM
Cash dispensers are available on levels -1 and 0.
The 27th Annual EuroMeeting has been awarded 13.75 CPD credits from the
Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians
(RCP) of the UK. Medical practitioners who are eligible for credits can click
on http://www.fpm.org.uk/cpd/registration for more information. If you are
already a CPD member, please go directly to http://cpd.fpm.org.uk to claim
your credits.
DIA Booth
Find out more about all DIA can offer you, how membership can advance your
career, how to join a DIA Community, submit an article for publication and
lots more, at the DIA Booth # 3.D17. Stop by at the DIA Booth in the Havane
Exhibition Hall on Level 3. See Exhibition for opening hours.
DIA Patient Booth
DIA actively promotes the involvement of patient representatives in the
EuroMeeting. Since 2006, more than 200 patient representatives have been
involved as participants, speakers, session chairs, and also in the Programme
Committee. The Patient Fellowship Booth #3.D06 is located on Level 3 and acts
as a focal point for patient fellows and other stakeholders to meet and network.
Exhibition
Visit the joint EuroMeeting and Clinical Forum Exhibition, with 140+ companies
and service providers in a single venue. With many new companies exhibiting
this year, the exhibition offers more opportunities than ever to connect with
participants.
Monday
Tuesday
Wednesday
12:00 - 18:00
08:00 - 18:30 | Public Access 14:00 - 15:30
08:00 - 16:00
Please see the exhibition floor plan and list of exhibiting companies in the
Exhibition Guide, or use the interactive floor plan in the DIA Global" mobile
app.
Business Centre
Please note that there is no business centre at the Palais des Congrs de Paris.
There is a copy/printing shop within 5 minutes walking distance from the Palais
des Congrs, located at 62, Avenue de la grande Arme.
www.copytop.com/agence-grande-armee-maillot
Exhibitor Services
The Exhibitor Services Desks are located in Hall Maillot on Level 2. See Exhibition
for opening hours.
Certificate of Attendance
A Certificate of Attendance can be printed at the Scan-and-Go desks in Hall
Bordeaux on Level 3 on Wednesday, 15 April 2015 from 10:30.
First Aid
A pharmacy located in the shopping center on Level 0 is open daily from 09:00
to 20:00. For medical assistance during the conference hours, please visit the
DIA Onsite Registration Desk. Alternatively, any DIA host/hostess will be more
than happy to be of assistance.
Cloakroom/Baggage
The cloakroom is in the Entrance Hall in Hall Bordeaux on Level 3. There is a
charge of 2 per coat/jacket and 3 per piece of luggage.
Monday
Tuesday
Wednesday
08:00 - 21:00
08:00 - 19:00
08:00 - 18:00
Conference Bags
All attendees with a full meeting registration can collect a conference bag from
the Conference Bag Distribution Point in Hall Bordeaux on Level 3. Please bring
the bag voucher you received when collecting your badge.
Credits
DIA meetings are accredited by the SwAPP (Swiss Association of Pharmaceutical
Professionals) Commission for Professional Development (CPD) and SGPM
(Swiss Society of Pharmaceutical Medicine).
Hotel Accommodation Information

If you have any queries about hotel accommodation, please visit the Hotel
Information counter at the DIA Registration Desk located in Hall Bordeaux on
Level 3.
Information Desks
If you have any questions about the Clinical Forum or the EuroMeeting, from
finding session rooms to networking activities, stop by the DIA Information
Desks located on Level 2 and Level 3. Alternatively, any staff member or DIA
host/hostess will be more than happy to be of assistance.
Monday
Tuesday
Wednesday
08:00 - 18:00
08:00 - 18:30
08:00 - 16:00

GENERAL INFORMATION A-Z

Lost and Found
All items will be stored at the DIA Registration Desk in Hall Bordeaux on Level
3 until the end of the conference.
Monday
12:00 - 14:00 Lunch
15:00 - 16:00 Afternoon tea/coffee with snack
Members Lounge
V.I.P. Feeling for DIA Members
DIA Members can relax in the Members-only Lounge in the Exhibition Hall on
level 3 during breaks, or whenever a few minutes in a quiet setting is needed.
Coffee and drinks are served throughout exhibition opening hours and charging
stations for your electronic devices are available. Make sure you bring your
membership card to identify yourself as a DIA Member at the desk. Access
exclusively for DIA Members.
Tuesday
10:15 - 11:00 Morning tea/coffee with snack
12:00 - 14:30 Lunch
Messaging Services
Download the DIA Global mobile app and use the messaging function to set
appointments or send messages to other attendees.
Water dispensers are located around the Exhibition Hall and session room
hallways.
Posters
Student, professional and patient representative posters will be displayed in
the Bordeaux/Havane Hallway on Level 3. Come and talk to our student poster
presenters during lunchtime on Tuesday between 13:00 and 14:00. A selected
group of professional poster presenters will share their research results on
various topics.
Join us at the DIA Booth #3.D17 on Level 3 on the Exhibition Floor for the
Student Poster Award Ceremony on Tuesday, 14 April 2015 at 17:45.
Name Badge
Name badges must be worn at all times in the Conference Center. Participants
will incur a 25 fee for badge reprints. If you have misplaced your badge,
you will be required to have a badge reprinted. Please visit Attendee Onsite
Registration located in Hall Bordeaux on Level 3. Identification will be required.
Please note, allowing exhibitors to scan the barcode on the front of your badge
will provide them with your contact information. No children under the age of
18 years will be allowed in the Exhibition Halls due to liability issues.
Presentations
Presentations will be available to full conference attendees on the DIA web
site from 9 April until 15 Ocotber 2015. Presentations are made available to full
conference attendees only.
To access presentations, visit diahome.org/EM2015 and follow the links for the
EuroMeeting presentations.
Press Lounge
The Press Lounge is located in Room 204 on Level 3.
DIA welcomes qualified representatives of news organisations for the
purpose of reporting and publishing and broadcasting articles and stories. All
media must present a copy of their press credentials upon arrival at the DIA
Registration Desk. For more information, please contact Jacqueline Bowman
on EUPress@diaeurope.org
Monday
Tuesday
Wednesday
12:00 - 17:45
08:00 - 18:30
08:00 - 16:00
Refreshments/Lunches
Refreshments and Lunches will be served each day on the Exhibition Floors
on Levels 2 and 3. Enjoy extended refreshment and lunch hours to visit more
than 140 exhibiting companies.
Wednesday
10:15 - 11:00 Morning tea/coffee with snack
12:00 - 14:00 Lunch
Registration
Registration is located in Hall Bordeaux on Level 3 and will be open as follows:
Sunday
Monday
Tuesday
Wednesday
14:00 - 18:00
08:00 - 18:00
08:00 - 18:00
08:00 - 17:30
Security
We take the safety of our participants very seriously. Please help us by
cooperating fully with the security personnel on duty and wear your badge at all
times. Only participants with a valid conference badge will be allowed into the
conference center.
Services for the Disabled
All the rooms at the congress centre are fully accessible to participants with
disabilities.
Shopping centre
The Palais des Congrs de Paris has a shopping center with 70 shops: Palais
Boutiques (www.lesboutiquesdupalais.com).
Speaker Resource Center
All speakers are required to visit the Speaker Resource Center located in room
341 on Level 3 and re-check their slides at least 2 hours before the start of their
session(s).
Sunday
Monday
Tuesday
Wednesday
14:00 - 18:00
08:00 - 18:00
08:00 - 18:00
08:00 - 16:00
Student Corner
A dedicated area is located in Booth #3.A07 in the Exhibition Hall on Level 3 for
students to network, plan their day, and meet for lunch.
Twitter
Tweet about the EuroMeeting using #Euro and @DIA_Europe
WiFi
Wireless internet access is available throughout the conference center and is
powered by Oracle Health Sciences.
Network:
DIA 2015
Password: PARIS2015

Thanks to our Contributors!

DIA would like to express its sincere thanks to the following exhibitors for their contributions and support
of the 27th Annual EuroMeeting & 8th Annual Clinical Forum
Oracle Health Sciences

Booth 2.C09
WIFI and Exhibit Hall Signage
APCER PHARMA
Booth 2.D12
Welcome to Paris Reception
Thanks to our Media Partners!
International Pharmaceutical Industry
Supporting the industry through communication
JOURNAL FOR
U
CLINICAL STUDIES
Your Resource for Multisite Studies & Emerging Markets
from diagnosis to cure
Accenture Life Services

Booth 2.E18
Recharging Stations

DIA AWARD WINNERS

Outstanding Contribution
to Health Award
Dr June Raine
Director of Vigilance and Risk Management of Medicines
Medicines and Healthcare products Regulatory Agency
(MHRA)
Dr June Raine trained in general medicine in Oxford after completing a
Master degree by research in Pharmacology. Her interest in drug safety
led to a career in medicines regulation which has spanned a number of
roles in assessment, management and strategic development within the
UK national authority. Appointed in 1999 to head Pharmacovigilance in
the Medicines Control Agency (now Medicines and Healthcare products
Regulatory Agency), she was elected in 2005 to chair the CHMPs
Pharmacovigilance Working Party and in 2012 as the first chair of the
Pharmacovigilance Risk Assessment Committee. She is also a member
of the WHO Advisory Committee on Safety of Medicinal Products. Her
special interests are in monitoring the outcomes of regulatory action, risk
communication and patient involvement in the regulatory process. She has
made outstanding contributions towards delivering a world-class European
Union pharmacovigilance system. She has served as DIA EuroMeeting
Programme co-Chair and has been a welcomed Speaker at DIA.
Excellence in Service Award

Dr Birka Lehmann
Head of Executive Department EU and International Affairs
of the Federal Institute for Drugs and Medical Devices
(BfArM)
Dr Birka Lehmann studied Medicines at the Free University Berlin and

trained at the Kinderklinik Norderney. Her working experience includes 9
years preclinical assessment in the division Pharmacology and Toxicology
of BfArM and she served as head of unit Decentralised Procedure (19962002) and as deputy head of EU Division (2000-2002). From 2002
2006 she joined the European Commission, Directorate-General Enterprise
and Industry as expert on secondment to in the unit Pharmaceuticals
responsible for inter alia Marketing Authorisation and implementation of
Clinical Trials Directive. From September 2006 till October 2011 she was
head of the division 3 Marketing Authorisation procedure at the BfArM.
Since 2007 she is member of the Paediatric Committee at the European
Medicines Agency.
She contributed continuously since 1994 to the DIA EuroMeetings, DIA
Annual Meetings and several conferences, training courses and workshops.
In 2004 she co-chaired with Yves Juillet the DIA EuroMeeting in Prague.
Since 2013 she is chair of the Content Committee for DIA Europe, Middle
East and Africa and a member of the DIA Advisory Committee for Europe,
Middle East & Africa.

Rolf Banholzer, PhD
Global Head e-Clinical QA, Novartis Development, Basel
Rolf Banholzer has a PhD in Molecular Biology from the University of Basel.
His focus on Computer Systems to be understood as an integral part of
efficient and compliant clinical processes and must enable end to end data
integrity in the clinical research and development process.
He acts as a translator between IT and Business to obtain optimal user
requirements as the basis for successful implementation of IT systems.
He promotes clear and transparent communication as well as striving
for simplicity, imperative to manage the ever increasing complexity of
computer systems.
He works for Novartis in Basel since 17 years in roles with increasing
responsibility. He started as a Safety System Administrator and then moved
to a Business Analyst role in the Pharmacovigilance area before he took
over a global team of QA IT Systems and Process Experts responsible for
all IT systems in Novartis Pharma Development. Since almost 2 years, he is
also providing QA oversight over clinical data management and statistics
processes with his team.
He was co-leading the DIA/ISPE CSV workshop recently held in Basel,
is actively supporting the organization committee of the DIA EU Clinical
Forum and he is a member of the DIA Advisory Committee for Europe,
Middle East & Africa.

Breffni Martin
Director, Regintel, Ireland
Breffni Martin was educated at St Micheals College Dublin and Cistercian

College Roscrea. At University College Dublin he received his BSc
specialising in biochemistry in 1983. Thereafter he worked for a number of
major pharmaceutical companies in the area of late stage drug development,
in both a scientific, regulatory and information technology context, as well
as in environmental management. These include GlaxoSmithKline, BristolMyers Squibb, Laboratoire Guerbet and Fermenta (a Pharmacia spin-off).
In 1997 he joined IMS Health (IDRAC, a regulatory intelligence company)
where he developed regulatory content covering North America, Japan,
Australia and elsewhere, including a dedicated FDA Advisory Committee
intelligence business. He subsequently set up and operated regintel and
CanReg (Europe), regulatory intelligence and services companies.
He is a long-standing member of the DIA a regular programme chair,
speaker and contributor to DIAs meetings and publications. He was coleading the DIA/ISPE CSV workshop recently held in Basel and he served
on the DIA Advisory Committee for Europe from 2004 2009.
10

PROFESSIONAL POSTERS
PROFESSIONAL POSTER AUTHORS
A selected group of professional poster presenters will share their
research results in various topics. Visit the hallway of Hall Bordeaux on
Level 3 to view the Professional Posters.
P1

P2
P3

P4

P5

P6

P7

P8

P9

Tatyana Benichiva, Professor Drug Regulatory Affairs, Faculty of

Public Health, Medical University Sofia, Bulgaria
HTA Methodologies of Novel Treatments
(T.Benisheva, G.Petrova, A.Stoimenova, A.Savova, D.Sidgimova,
P.Trendafilova, V.Petkova)
Romuald Braun, CEO, Uanotau, Switzerland
How IDMP Can Help Structure Product Information/ Labelling
Magadalena Bujar, Research Analyst, Centre for Innovation in
Regulatory Science (CIRS), UK
Expediting the Availability of New Medicines: What Role Do Priority
Pathways and Special Designations PlayiIn ICH Countries
Daniele De Martini, Academic Professor, Universit Di Milano
Biocca, Italy
Evaluations When Adaptation by Design Is Applied
Claudia Hernandez, Associate Director Regulatory Affairs,
Sunovion Pharmaceuticals Inc., USA
Clinical Trial Application Approval Rates for Global Paediatric
Placebo Controlled Trials
Sherri Hubby, Director, US Quality Assurance, Premier Research
Group, USA
A Compare and Contrast of Significant Changes in Clinical Trial
Regulation of FDA, EMA and PDMA and Inspectional Readiness
Tatsuya Ito, Visiting Fellow in Research Integrity, Research and
Enterprise Development, University of Bristol, UK
Comparison of the Research Governance Frameworks for Research
Involving Humans, Their Tissue and/or Data in the UK and Japan
Christa Janko, Project Manager, Medical University of Vienna,
Austria
Stay Ahead in Biomedical Sciences Catch the LifeTrain
Heinrich Klech, Medical University of Vienna, Austria
The Specialist in Medicines Development (SMD) A Global
Certification Programme by PharmaTrain Federation
P10 George Mathis, CEO, Appletree CI Group AG, Switzerland

Clinical Development of Medical Devices in Europe and the USA
Differences and Similarities
P11 Magdalena Matusiak, Manager, Clinical Development, KCR SA,
Poland

Safety Monitoring and Reporting in Clinical Trials Ensuring Quality
and Effectiveness
P12 Stella Mokiou, Research Scientist, UBC: An Express Scripts

Company, UK

Use of Patient-Reported Outcomes in Post-Authorisation Safety
Studies: A Targeted Review
P13 Marie Lou Munson, Safety Science Leader, Genentech, USA

Application of the DILI Expert Working Group Criteria in the
Assessment of Hepatotoxicity
P14 Toshinori Murayama, Professor, Kanazawa University Hospital,
Japan

Toward The Advancement for Investigator- Initiated Clinical Trials
A Challenge From Kanazawa/Hokuriku in Japan
P15 Nermina Nakas, Inventiv Health Clinical, USA

Pharmacovigilance and Safety: Pediatric Research Challenges
P16 Sue Rees, QPPV, Executive Director Global Safety, Amgen Ltd, UK

Pharmacovigilance Process Redesign Changing the Wheels Whilst
the Car Is Moving
P17 Joerg Seebeck, Chief Medical Officer, PrimeVigilance Ltd, UK

QT-Prolonging Effects of Biological Drugs in Humans: A Systematic
Review of a Literature and Public Adverse Event Database
P18 Iris Tam, Director, Managed Care Medical Communications,
Genentech, USA

A Review of the World Health Organization (WHO) Essential
Medicines List (EML) Decision Making Process
P19 Marie Trad, Quintiles, France

Epidemiological Data: An Untapped Resource for Developing an
Operational Strategy for Clinical Trials in Rare Diseases
P20 Jasper Van Berkel, National Institute of Public Health and the
Environment, the Netherlands

Empowerment of Patients in Online Discussions about Medicine Use
P21 Linda Van Kerkof, National Institute of Public Health and the
Environment, the Netherlands

Characterisation of Apps and Other E-Tools for Medication Use
P22 Angela Van der Salm, Director Pharmacovigilance, Dada
Consultancy B.V., the Netherlands

Potential for Medication Errors or Off-label Use Practical
Challenges
P23 Judy Walker, Drug Safety and Product Advisory Services, Quintiles,
USA

Benefit-Risk Assessments (BRAs) of an Established Products
Portfolio (M. Mease and J. Walker)
P24 Janine Collins, Senior Director, European Risk Management, United
Biosource Corporation, Switzerland

Failure Modes and Effects Analysis strategy to minimise and
mitigate risks associated with home administration of drug

11
STUDENT POSTERS | PATIENTS ADVOCATES
STUDENT POSTER AUTHORS

Student abstracts selected by the review committee, addressing similar
topics to those in the programme, will be on display in the hallway of Hall
Bordeaix on Level 3.
PATIENT ADVOCATES AT THE EUROMEETING

Vesna Aleksovska, Association of citizens for rare diseases - Life with
Challenges, Republic of Macedonia
Dimitris Athanasiou, Parents Project MDA Hellas, Greece
Claudia Crocione, HHT ONLCUS - Italian Association for Hereditary
Presenters will be able to discuss their work during the coffee and lunch
breaks on Tuesday, 14 April 2015. An awards ceremony will be held on
Tuesday, 14 April 2015 at 17:45 at the DIA Booth in the exhibition hall to
award the first and second place student poster winners.
Poster Selection Committee:
Gaby Danan, Pharmacovigilance Expert, France
Angelika Joos, Executive Director, Global Regulatory Policy, MSD (Europe)
Inc., Belgium
Birka Lehmann, Head of Executive Department EU and International Affairs
of the Federal Institute for Drugs and Medical Devices (BfArM), Germany
Hemorrhagic Telandiectasia, Itlay

Ivana Dragoievic, HRONOS, Serbia
Esraa El-Sherbiny, CanSurvive, Egypt
Elisabetta Gecchele, Acondroplasia Insieme Per Crescere - ONLUS, Italy
Tess Harris, Polycystic Kidney Disease Charity, UK
Alexander Kosenko, Russian Union of Patients and Patients Organisations
of Rare Diseases, Russia
Boris Machavariani, The Alliance of CMI Patients of Georgia, Georgia
Ananda Plate, Myeloma Patients Europe (MPE) AISBL, Belgium
Ieva Plume, PHA Latvia, Latvia
Jill Prawer, LPLD on RareConnect, UK
SP1 Nadia Amaouche, University of Paris-Sud, France

European Paediatric Regulation launched in 2007: Feedback since
its implementation and perspective for 2017 and beyond
SP2 Liban Ashkir, University of East Anglia, UK

The ECG effects of Moxifloxacin in thorough QT Trials: Systematic
review exploring the impact of design features
SP3 Amandine Beras, Claude Bernard Lyon 1, France

The new version of international electronic transmission of adverse
drug reactions: E2B (R3)
Ana Sofia, S Cardoso, APCL, Portugal

Antonella Esposito, Angeli Noonan Onlus, Italy
Juan Fuertes-Guillen, Pulmonary Hypertension Association (PHA) Europe,
Spain
Anne Hugon, AFG French Glycogen Storage Disease Association, France
Mary Lynne Van PoelGeest-Pomfret, World Federation For Incontinent
Patients (WFIP), the Netherlands
Nicola Bedlington, EPF, Belgium
Rob Camp, EURORDIS, France
Jan Geissler, EUPATI, Belgium
SP4 Emeline Blanc, Claude Bernard Lyon 1, France

Counterfeit drugs: means and technologies to fight against this peril
in ICH countries
David Haerry, European AIDS Treatment Goup, EU
SP5 Ioana-Laura Bogdan, Carol Davila University of Medicine and

Pharmacy, Romania

Pharmacy-ethics and economic constraints
Alison Lightbourne, IAPO, UK
SP6 Marija Simaitien, Lithuanian University of Health Sciences,

Lithuania

Prevalence, risk factors and self-management strategies of primary
dysmenorrhea among Lithuanian women
Francois Houyez, EURORDIS, France

Alistair Kent, Genetic Alliance, UK
Badri Rengarajan, International Pemphigus and Pemphigoid Foundation,
United States
Bettina Ryll, Melanoma Patient Network Europe, Belgium
Christoph Thalheim, European Multiple Sclerosis Platform, Belgium
Barbro Westerholm, AGE Platform, Sweden
Phil Willan, Healthcare Quality Improvement Partnership (HQIP), UK
Yann Le Cam, Eurordis, France
SP7 Solne Viera de Araujo, Claude Bernard Lyon 1, France

What could be publicly retrieved from adverse drug reaction
databases? An overview of 10 pharmacovigilance databases
Durhane Wong-Reider, Canadian Organization for Rare Disorders, Canada
PATIENT WELCOME LUNCH

Monday, 13 April 2015 | 12:30 - 14:00 | Room Arlequin Level 3
Reserved for patient representatives and patient speakers only
Overview of the EuroMeeting scientific programme and an
opportunity for patient representatives to meet and network with
each other prior to the conference.
DIA Communities:
Get Engaged.
Develop Your Horizons.
To learn more about

DIA Communities visit the
DIA Booth #3.D17 or stop
by the Membership Lounge
located on Level 3 or scan the
QR code below.
DIA Communities
Meet & Eat
Together We Can Do So Much
DIAs Communities provide our members with an opportunity to
build relationships across disciplines and around the world and at

the same time contribute to improving the process of health care
product development.
Tuesday, 14 April 2015 | 13:00-14:00

Room Arlequin, Level 3
DIA Communities
Are you active in a Community? Come attend

a relaxed, informal and rare opportunity
to meet your fellow Community members
face-to-face. Enjoy your lunch and share
your experiences with those who are curious
about DIA Communities.
provide a way for members across the globe to interact with their
peers and to form cross-disciplinary teams. It is here that members
share information, raise concerns, mentor one another, and find
answers togetheraccomplishing more as a group than any one
person could accomplish alone. DIA members are encouraged to
join those Communities that match their interest areas.
New to DIA? Not part of a Community?

Youre invited too! This is an opportunity
to ask questions and learn more about this
member benefit. Look for DIA Community
members who will be wearing a special
button.
Scan this QR code

to learn more about
DIA Communities
DIA Membership
Its all about connections
With DIA, people and ideas come together on a global scale to accelerate
innovation and identify solutions. DIA provides invaluable forums to network
with your peers, build new relationships, share ideas, and gain knowledge that
can improve health care around the world.
As a DIA member, you will:
Be a part of a global network, working to advance health care
product development
Work closely with like-minded professionals to solve real issues
through DIA Communities and Scientific Task Forces
Enjoy discounts on more than 200 educational opportunities
offered worldwide each year
Keep informed of news as it happens with our daily enewsletter
Learn the latest on health care products and regulatory science
through our bi-monthly news magazine
Read about recent discoveriesand submit your own
papersthrough our peer-reviewed scientific journal
The more you engage, the more you gain.
Together we can create a

world where improved health
is a reality for everyone
To learn more about

DIA Membership visit the
DIA Booth # 3.D17 or stop by
the Members Lounge located
on Level 3 or scan the QR code
below.
DIA Members Lounge

Hall Bordeaux Level 3
Are you looking for a space to relax or connect
with other DIA members? Stop by the Members
Lounge located in the Hall Bordeaux on Level 3.
This exclusive lounge offers members a place to
take an important call, get online, charge devices
or just relax.
Coffee and drinks are served throughout exhibition
opening hours and charging stations for your
electronic devices are available. Make sure you
bring your membership card to identify yourself
as a DIA Member at the desk. Access exclusively
for DIA Members.
Note: if you have not yet received your new
membership card, have it printed onsite in the
Members Lounge.
The goal of DIA is simple:

To help you gain the knowledge you need to improve
health and wellbeing worldwide.
DIA and You: Driving Ideas to Action
Join DIA. Visit DIAGlobal.org/Membership
Scan this QR code

to learn more about
DIA Membership
16

OPTIONAL EUROMEETING
PRE-CONFERENCE TUTORIALS
MONDAY, 13 APRIL 2015 | 09:00-12:30
EM Tutorial 1 | Monday 13 April 2015, 09:00-12:30
Room 252B Level 2
HOT TOPICS IN PHARMACOVIGILANCE AND ADVERSE REACTION
REPORTING
Sabine Brosch, Principle Scientific Administrator, European Medicines
Agency, EU
Gaby Danan, Pharmacovigilance Expert, France
Taking into account the implementation experience with GVP module VI,
which came into force on 2 July 2012, this tutorial will focus on frequently
asked questions from stakeholders with regards to the day-to-day
operational aspects.
In addition, practical considerations on the update of GVP module VI
focusing on a simplification of the reporting of suspected adverse reactions
from non-interventional post-authorisation studies, compassionate use
and patient support programmes will be addressed.
At the start of 2015, the European Medicines Agency will launch a new
process of monitoring medical literature for selected substances and
selected medical literature in line with the provisions set out in Article 27 of
Regulation 726/2004. The tutorial will provide the opportunity to discuss
first experiences of marketing authorisation holders (MAHs) and to address
specific implementation questions.
Article 24 of Regulation 726/2004 also outlines a new approach for
marketing authorisation holders to access EU adverse reaction reports
directly in EudraVigilance, following the successful outcome of an audit
of the European pharmacovigilance database. In preparation of these
changes, the EudraVigilance Access Policy will be updated to define the
data elements of Individual Case Safety Reports (ICSR) for which access
can be provided in compliance with EU personal data protection legislation.
The tutorial will provide an opportunity to discuss those data elements
in support of the marketing authorisation holders pharmacovigilance
obligations.
The tutorial will conclude with a detailed discussion of the reporting
principles in line with the new ICH Individual Case Safety Report E2B (3)
guideline thereby highlighting new concepts such as causality assessment
at event level, drug reaction relatedness, amendment reports and
reporting of special situations (e.g. counterfeit medicines, product defects,
medication errors).
Learning Objectives
At the conclusion of this tutorial, attendees will be able to:
Address FAQs on GVP Module VI Management and reporting of adverse
reactions to medicinal products and recent updates
Discuss the new process for monitoring of medical literature by the EMA
and the potential impact on MAHs
Describe the principles of access to EudraVigilance based on revised
policy
Discuss reporting principles based on the new ICH ICSR E2B(R3)
guideline
Target Audience
This tutorial is designed for Qualified Persons Responsible for
Pharmacovigilance (QPPVs) and individuals involved in Pharmacovigilance,
clinical development, information management, and safety databases.
Room 253 Level 2
INTERACTIONS BETWEEN REGULATORY AND LEGAL IN INTELLECTUAL
PROPERTY, PRODUCT LIABILITY AND COMPETITION
Genevive Michaux, Counsel, Hunton & Williams, Belgium
Karina Hellbert, Partner, FIEBINGER POLAK LEON RECHTSANWLTE
GmbH, Austria
Interactions between the regulatory regime and intellectual property (for
example, SPC, data exclusivity), product liability (e.g., off label information
in summary of product characteristics (SmPC), competition (for example,
public procurement) and privacy (e.g., clinical trials) rules are increasing.
As a result, those matters can no longer be approached in isolation, and a
more comprehensive perspective is required when addressing regulatory
issues.
Learning Objectives
At the conclusion of this tutorial, participants will be able to:
Explain and discuss the basics of intellectual property, product liability
and competition rules applicable to medicinal products
Identify and better address the regulatory issues that present an
intellectual property, product liability or competition aspect
Target Audience
The tutorial is designed for non lawyers with good regulatory experience
and for regulatory lawyers who want to learn the basics of intellectual
property, competition, and product liability rules as they apply to the
pharmaceutical sector.
Room 251 Level 2
ANALYSIS OF SAFETY DATA FROM CLINICAL TRIALS
Jrgen Kbler, Global Head, Clinical Design, Analysis and Reporting, CSL
Behring AG, Germany
Christine Wichems, Global Head of Medical Writing and Disclosure, CSL
Behring GmbH, Germany
This tutorial is a combination of theory, guidelines, practical considerations,
and real-life solutions for those working in the clinical development
environment (pharmaceutical, biotech industry, or CRO). The aim of this
tutorial is to provide a basic understanding of the underlying methodology
and the current guidelines on safety data. Aspects of the planning of
clinical trials as well as the problems and pitfalls during the analysis of
safety data will be presented. Opportunities for prospective planning of
safety analysis at the project level will be discussed. The presentations will
also include case studies.

17
MONDAY, 13 APRIL 2015 | 09:00-12:30
Learning Objectives
At the conclusion of this tutorial, participants should be able to:
Examine relevant guidelines and regulatory requirements for clinical
trials
Recognise how to contribute to safety analysis plans
Assess statistical safety analysis and identify pitfalls in safety analysis
Recognise the impact of benefit/risk assessment in safety data
Target Audience
This tutorial is designed for biostatisticians, medical writers, clinical
researchers, drug safety specialists, project managers, and investigators.
Room 252A Level 2
PRIVACY AND PERSONAL DATA PROTECTION IN DRUG DEVELOPMENT
Pierre-Yves Lastic, Associate Vice President, Chief Privacy Officer, Sanofi,
France
This tutorial addresses issues in data privacy today:
Why is personal data protection important?
Principles of personal data protection, based on the European
regulations
Overview of worldwide regulations and the differences between them
Specific regulations for biomedical research and pharmacovigilance
impacting drug development
How to comply?
Information & consent
Communication & training
IT security & validation
Legal instruments (contracts, Safe Harbor, BCRs)
Data Privacy organisation
Learning Objectives
At the conclusion of this tutorial, participants should be able to:
Understand the principles of personal data protection in the European
Union
Understand the differences between European, US and Asian data
privacy regulations
Have a basic knowledge on how to comply with regulations in the
specific field of drug development
Target Audience
This tutorial is designed for:
All individuals involved in the organisation and management of clinical
trials and pharmacovigilance, or handling data collected to perform
these activities
Professionals working with health data, clinical data, genetic data, tissue
samples, medical imaging, mobile health apps, and any kind of personal
data in the field of drug development

Room 241 Level 2
MOVING FROM RISK MANAGEMENT TO BENEFIT/RISK MANAGEMENT
EMBEDDING PHARMACOVIGILANCE PRINCIPLES INTO THE PRODUCT
LIFE CYCLE
Shelley Gandhi, Director Pharmacovigilance and Drug Safety, NDA Group,
UK
William Richardson, Medical Advisor, NDA Group, UK
Pharmacovigilance, or the activity of monitoring the safety of medicines in
clinical use and taking appropriate action to minimise risk, is governed by
a range of new EU legislation, a new Pharmacovigilance Risk Assessment
Committee and guidance. The value that can be gained from adopting a
benefit/risk management system not only addresses known and potential
risks to support the current regulatory status of product but also will feed
into the further development of a product as regard new indications and
potentially moving from prescription only to over the counter.
This tutorial will discuss how access to robust evidence on emerging risk
in post-authorisation phase, good data on how a medicine is used in
clinical practice and data on background rates in the exposed population
gathering evidence throughout the product lifecycle will help move
companies to a benefit/risk system. The ultimate challenge is working
towards an integrated regulatory system so you can query across all
information within a company, designing safety studies, monitoring the
effectiveness of the risk management systems and gather robust evidence
from clinical practice.
The lessons learned and our experiences so far with post-authorisation
commitments (e.g. BRMPs, PASS, PSURs) will be reviewed as will whether
these commitments really do support an acceptable benefit/risk profile.
This will include the novel approaches to managing benefit/risk to meet the
needs of licensing medicines in biotechnology such as advanced therapies.
Communicating benefit/risk will also be discussed as the new legislation
will push for greater patient involvement within a benefit/risk system.
Better methodologies and tools are required to support this integrated
approach and adoption of a quality management system across global
enterprise could achieve this.
Learning Objectives
Learn about what are effective strategies and the current thinking on
risk mitigation in the context of benefit throughout the product lifecycle.
Access to robust evidence on emerging risk is critical
Discover what the principles are for proportionate risk based assessment
Find out about hurdles which get in the way to a systematic approach
and how these might be tackled
18

MONDAY, 13 APRIL 2015 | 09:00-12:30
Target Audience
Professionals in companies or regulatory authorities who are involved in
pharmacovigilance operations and with responsibilities for post marketing
clinical safety including those who are involved in:
Pharmacovigilance
Regulatory
Clinical research
Risk management
Medical product safety assessment
Data analysis
Epidemiology
Labelling
Quality assurance and compliance
Target Audience
Modeller, biostatisticians, medical writers, clinical researchers, drug
safety specialists, project managers, investigators, clinical practitioners,
physicians, regulators, with basic experience/awareness of Modelling
and Simulation (M&S)/Model Informed Drug Discovery and Development
(MID3).

Room 242A Level 2
MODELLING AND SIMULATION (M&S) / MODEL INFORMED DRUG DISCOVERY AND DEVELOPMENT (MID3)
Amy Cheung, Clinical Pharmacometrician, AstraZeneca R&D, UK
Flora Musuamba Tshinanu, Research Associate, University of London, UK
EUROPE, MIDDLE EAST & AFRICA
The tutorial will be an opportunity to understand better the value of

Modelling and Simulation (M&S) / Model Informed Drug Discovery and
Development (MID3) in the development of new medicinal products, and
the impact of MID3 on regulatory decision making and product labelling.
CHEMISTRY, MANUFACTURING
& CONTROLS
The tutorial will be divided in three parts.
21-23 SEP VIENNA, AUSTRIA | #15543

Quality by Design - New concepts for chemical and
biotech product development and optimisation
First, the basic concepts and principles of modelling and simulation will be
recalled and the added value over two stage approach will be discussed
using examples.
The second part will be dedicated to the use of M&S and MID3 in the context
of drug development and the impact it can have in key decision making:
study design optimization, data analysis, dose selection and extrapolation
will be discussed.
The last part will be dedicated to model evaluation given the purpose. For
each of the application of M&S/MID3 in drug development, the relevant
criteria for model evaluation will be presented and discussed. Focus will
be made on data needed, model assumptions and uncertainties and fitting
performances and examples will be provided for good and bad practices.
Challenges in current practices (given the current regulatory requirements)
will also be discussed.
Learning Objectives
Recall the basic concepts of Modelling and Simulation and its advantages
over other approaches for Pharmacokinetics (PK) / Pharmacodynamcis
(PD) description and predictions
Discuss/explain the added-value and importance of Modelling and
Simulation Model Informed Drug Discovery and Development in the
context of drug development
Outline/discuss the criteria for model evaluation given the purpose in
drug development setting
2015
TRAINING
COURSES
Participants from pharmaceutical, biotech and generic

industry as well as regulators will learn how to use QRM,
Process Characterisation, DoE, Development of a Design
Space and Control Strategy, as well as the tools of
Knowledge Management (KM).
The 8th Annual Clinical Forum will take place in parallel of the 27th Annual EuroMeeting.
Participants have the opportunity to register for optional tutorials for both conferences.
OPTIONAL CLINICAL FORUM

MONDAY, 13 APRIL 2015 | 14:00-17:30
CF Tutorial 1 | Monday 13 April 2015, 14:00-17:30
CF Tutorial 2 | Monday 13 April 2015, 14:00-17:30
Room 242A Level 2
Room 242B Level 2
A LEGAL UPDATE: RECENT AND CURRENT DEVELOPMENTS IN

EUROPEAN PHARMACEUTICAL LAW
John Lisman, Lawyer, Lisman Legal Life Sciences, Netherlands
Koosje van Lessen Kloeke, Life Sciences Lawyer Partner, Leijnse Artz
advocaten, Netherlands
ENSURING DATA QUALITY AND DETECTING POTENTIAL FRAUD/GCP

MISCONDUCT
Marc Buyse, Chairman, IDDI (International Drug Development Institute)
Inc., USA
Stephen George, Department of Biostatistics and Bioinformatics, Duke
University School of Medicine, USA
Pharmaceutical law is at the basis of daily business in the pharmaceutical

and biotech industry. In the last few years many developments have
occurred in the field of pharmaceutical law, as well as in the marketing
authorisation practice.
This tutorial brings you up to date in respect to marketing authorisation
for Biosimilars - Paediatric Regulation - Advanced Therapy Medicinal
Products Regulation - Clinical Trials Regulation - Early Access to promising
new medicines - Adaptive licensing - Transparency. For each of these
topics the most relevant highlights will be presented in an interactive
manner. Furthermore, recent ECJ case law relevant for the audience will
be discussed.
Learning Objectives
Apply pharmaceutical legislation in their daily practice.
Explain the changes in pharmaceutical legislation in their companies.
Participate in an interactive way in the DIA Clinical Forum sessions
dealing with new legislation, e.g. Clinical Trial Regulation.
Recognise recent case law of the Court of Justice and the General Court.
Target Audience
Non-lawyers who work in a regulated (clinical or medical) environment
from industry, government agencies and competent authorities. Lawyers
from industry, government agencies and competent authorities who have
recently started in this position.
A large number of options are available to operationalise the recommendations

outlined in the FDA Guidance on Risk-Based Monitoring (RBM) and the
EMA Reflection Paper on Quality by Design. TransCelerates position paper
provides a detailed view of some of the tools and processes that can be used
for a successful implementation of RBM. This tutorial session will review the
landscape of current practices with a focus on data quality and integrity. The
session will demonstrate how analytical tools can support an RBM strategy
by analysing clinical data to identify risks in some sites arising from lack of
training, misunderstanding, carelessness, negligence or even fraud.
The session will cover the tenets of CSM (Central Statistical Monitoring) and
KRI (Key Risk Indicators). The types of findings that can be detected by these
two approaches will be discussed and illustrated with concrete examples.
Importance will be given on how the cause of the findings can be identified
and classified by seriousness, from poor protocol understanding to intent
to cheat. The operational implications of the findings in terms of corrective
actions to take will also be discussed.
Learning Objectives
Implement the recommendations outlined in the FDA Guidance on RiskBased Monitoring
Demonstrate how the use of objective, analytical tools can be used to
identify sites at risk and detect potential fraud
Interpret findings from KRIs and CSM to drive operational corrective
actions
Target Audience
Professionals involved in the management of clinical trials: Data Managers,
Statisticians, Medical Reviewers, Study Physicians, Project Managers, Study
Coordinators, Quality Managers and Senior Management.
SAVE TIME AND TRAVEL COSTS with
IN-HOUSE TRAINING
All DIA Training Courses can be held on your
premises and tailored to your needs.
Get the best value and train your whole team!
20

EU REGULATORY
TOWN HALL MEETING
50th Anniversary
of the EU Pharmaceutical Legislation
HAS SATELLITE SYMPOSIUM
MONDAY, 13 APRIL | 13:30-15:00

ROOM BORDEAUX LEVEL 3
MONDAY, 13 APRIL | 11:00-12:30

ROOM MAILLOT LEVEL 2
Moderator: Fernand Sauer, French Academy of Pharmacy,

Former Executive Director of the European Medicines, France
Introduction of Innovative Drugs and

Devices in France- Recent Advancements
in HTA, Pricing and Reimbursement
The Regulatory Town Hall will celebrate this unique occasion

with a panel discussion on how we can build on past
achievements to address the challenges ahead.
Moderator: Franois Meyer, Advisor to the President,

International Affairs, Haute Authorit de Sant (HAS), France
The European Commission will make an opening address

followed by the panel discussion covering these subjects:
Building the European Medicines Regulatory Network. How
is the house looking today and in the future?
What can regulatory authorities do to support innovation?
Implementing new legislation - what are the challenges,
what are the solutions?
How does France, one of Europes largest countries, deal with the
assessment and introduction of Innovative Drugs and Devices?
The session will provide an overview by HAS with regard to its
first-year experience in health economic assessments of new
health products, examine the current situation and challenges
of pricing for innovative drugs and devices and describe the
evaluation and decision-making process at the level of hospital
committees.
Introduction of Health Economics in the HTA Process for New
Drugs and Medical Devices in France: First-year experience
Jean-Luc Harousseau, President, Haute Autorit de Sant (HAS)
Price Determination for New Drugs and Medical Devices in
France: Current situation and perspectives
Dominique Giorgi, President, Comit Economique des Produits
de Sant (CEPS)
Role of Institutional Committees for Admission of New
Medicines and Innovative Medical Devices in French Hospitals
(COMEDIMS)
Philippe Lechat, French Society of Pharmacologie and
Therapeutics (SFPT)
Experience of Early Dialogue Pilots Conducted within SEED
and EUnetHTA: Coordinators perspective on the feasibility of
implementing a permanent model in Europe and the promise
of improving clinical data collection prior to market approval
Mira Pavlovic, Deputy Director DEMESP, Haute Autorit de Sant
(HAS)
The session will conclude with HASs experience in coordinating
the early dialogue/scientific advice activity in Europe through
the EUnetHTA and SEED projects, highlighting the benefits of a
collaborative approach between HTA agencies, regulatory and
health product developers.
Panellists:
Xavier De Cuyper, Chief Executive Officer, Federal Agency for
Medicines and Health Products, Belgium
Viola Macoli arini, Head of Agency, Agency for Medicinal
Products and Medical Devices (HALMED), Croatia
Guido Rasi, Principal Adviser, European Medicines Agency, EU
Andrzej Rys, Director of Health Systems and Products,
European Commission
Christoph Thalheim, Director External Affairs, European MS
Platform, Belgium
Christa Wirthumer-Hoche, Head, Austrian Medicines and
Medical Devices Agency (AGES), Austria
50 YEARS OF EDQM
Preparing for the Future to Continuously
Ensure the Quality of Medicines
WEDNESDAY, 15 APRIL | 11:00-12:30
ROOM MAILLOT LEVEL 2
Session Chair: Susanne Keitel, Director, EDQM/Council of
Europe
The European Directorate for the Quality of Medicines and
HealthCare (EDQM) turned 50 in 2014. While EDQM and its
37 Member States are proud of the tremendous achievements
over the past 50 years, globalisation and technical and scientific
developments in all fields pose constant challenges.
See page 46 for details.

OPENING PLENARY
MONDAY, 13 APRIL 2015 | 16:00 - 17:45 | BLUE ROOM LEVEL 2
ADVANCING INNOVATION TO COMBAT THE GLOBAL BURDEN OF
DISEASE: A CALL TO ACTION
A panel of respected leaders from academia, industry, health agencies, patient advocacy, and the payer
community will share perspectives on the dichotomy between evolving diseases, well-known conditions,
and neglected and rare diseases, contrasted with the challenges that exist in understanding the physiology
of these conditions and developing therapies to treat them.
The challenges include topics such as the efficiency of R&D, access to health care, ethics and transparency
issues related to the clinical trials, and the increasing challenges related to investments required to bring
safe, effective, economically-viable, and accessible products to patients worldwide.
All stakeholders see the challenges, but each from a different perspectives: health authorities in terms of
the public health preservation, industry in terms of ROI, academics in terms of generating new knowledge,
payers in terms of risk management, patients in terms of managing their disease.
During this provocative and stimulating discussion, the panellists will work to converge on a shared vision
and call to action.
Keynote Speakers:
Olivier Charmeil, Executive Vice President Vaccines, Sanofi, France
Andrew Morris, Professor, University of Edinburgh, Chairman and Centre Director, Farr Institute, UK
Panellists:
David Haerry, Board of Directors, European AIDS Treatment Group, EU
Hugo Hurts, Executive Director, Medicines Evaluation Board (MEB), the Netherlands
Guido Rasi, Principal Adviser, European Medicines Agency, EU
Moderator:
Maureen Kenny
Editor, Scrip Regulatory Affairs, Informa Business Intelligence, UK
21
22

Theme 1
Access to Innovative Treatments:
New R&D models and innovative
clinical trial methodologies. The
role of the new clinical trials
legislation
Susanna Del Signore, Associate Vice-President Global Regulatory
Affairs, Head of Global Regulatory Policy, Sanofi R&D, France
Dorthe Poulsen, Chief Legal Adviser, EU-Coordinator, Danish Health
and Medicines Authority (DKMA), Denmark
Researching and developing new medicines demands high levels of
innovation. This in turn delivers insights that benefits both society
and patients. This research is dependent on clinical trials; without
these, there would be no new medicines, no improvement of existing
medicines and no evidence-based improvement in how we use current
treatments.
Despite this, the number of clinical trials undertaken in Europe is
decreasing. Clearly, if we wish to stimulate healthcare R&D, we need
a robust, operative and cost-effective EU framework for clinical trials.
This theme will examine how we can use the new legal framework for
clinical trials to create this environment. How can we make the best use
of available tools whilst safeguarding the rights and safety of the clinical
trial subject? What are the considerations for clinical trial design, such
as location and disclosure requirements? Practically, how can we have
a regulatory system that lets us respond quickly to the demands of an
ageing population and a rapid rise in chronic conditions?
EM0101 | Tuesday, 14 April, 09:00-10:30 | Blue Room Level 2
Challenges in the Ethical Review of Clinical Trial Application

Wojciech Maselbas, Vice President, Association for Good Clinical Practice,
Poland
CLEARING THE PATH FOR INNOVATIONS IN DRUG DEVELOPMENT
Session Chair:
John Lisman, Lawyer, Lisman Legal Life Science, the Netherlands
This session will focus on the activities stakeholders perform to prepare
and implement the novelties in the Clinical Trials Regulation. What will
Member States do to lift their new responsibilities? How will industry adapt
to the new regulatory set-up and where do patients foresee strengths and
challenges?
Pathways for Early Access to Medicines - How can the use of existing tools
be improved from an industry perspective?
Sabine Atzor, Head of EU Regulatory Policies, F. Hoffmann-La Roche,
Switzerland
Member States Activities for Implementing Innovative Initiatives in
Respect of Clinical Trials
Christian Schneider, Senior Medical Officer, Danish Health and Medicines
Authority (DKMA), Denmark
Patients Expectations in Respect of the Development of New Medicines
Bettina Ryll, Founder, Melanoma Patient Network Europe, Sweden
PRIMARY FACTORS FOR TRIAL LOCATION
Session Chair:
Dorthe Poulsen, Chief Legal Adviser, EU-Coordinator, Danish Health and
Medicines Authority, Denmark
THE ROLE OF THE NEW CLINICAL TRIALS LEGISLATION

Session Chair:
Lidia Retkowska-Mika, Director, Legal Department, Office for Registration
of Medicinal Products, Poland
Which factors are decisive for the decision to conduct a clinical trial in a
certain part of the world? There is no doubt that the EU competes with
other parts of the world such as the BRIC countries. In this session, well
have a look at the EU in a more global context.
The objective of the session is to present and discuss major changes in

the overall approach, assessment, approval and conduct of clinical trials in
the EU introduced in the new legislation. New definitions, new procedures
for sponsors and Member States, the role of ethics committees, new IT
tools introduced in the legislation will be presented with the view to
inspire discussion on the forthcoming challenges and the use of new legal
instruments to make the EU a more attractive area for the conduct of
clinical trials.
Country Allocation in Global Perspective

Henrik Troelsen, Director, Global Trial Allocation, Novo Nordisk, Denmark
Key Content of the New Clinical Trials Legislation- Setting the scene
EMA Preparedness for the Implementation of the New Legislation
Ana Rodriguez, Head of Clinical and Non-Clinical Compliance, European
A Brazilian Perspective
Speaker invited
The Swedish Way to Foster Innovation
Christer Backman, EU Coordinator & Senior Expert, Medical Products
Agency (MPA), Sweden

23
EM0105 | Wednesday, 15 April, 09:00-10:30 | Room 251 Level 2
Alastair Kent, Director General, Genetic Alliance UK
IMPACT OF THE CLINICAL TRIAL REGULATION ON CMC FILING AND

RELEVANT GMP REQUIREMENTS
Chair invited
Nathalie Seigneuret, Senior Scientific Project Manager, Innovative Medicines

Initative (IMI), Belgium
The new Clinical Trial Regulation will be a key step towards supporting
medical research in Europe, covering multiple aspects of the clinical trial,
from the organisation, through implementation and the reporting process.
The quality of CT material needs to be properly designed and appropriately
manufactured. Which quality system should be applied? What are the
expectations from regulators at this stage? What consequences for the
industry?
This session will be a good opportunity, with appropriate timing, to go
through it and clarify the legal and regulatory impact (legislation and
delegated act) as well as identifying the challenges and opportunities for
the pharmaceutical industry.
How CTR May Change IMP Supply and How Ready Are We?
Anthony Moult, Director Clinical Supplies Operations, Daiichi Sankyo
Development, UK
Impact of the CTR on Investigational Product Supply - Potential
Challenges for the Industry
Sabine Pfister, Senior Compliance Professional, Quality Compliance &
Auditing, Novartis, Switzerland
EM0106 | Wednesday, 15 April, 11:00-12:30 | Blue Room Level 2
MEDICINES ADAPTIVE PATHWAYS TO PATIENTS (MAPPS) - HOLDING
HANDS ACROSS THE LIFECYCLE
Session Chair:
James Anderson, Head of Corporate Government Affairs, GlaxoSmithKline,
UK
MAPPs refer to flexible development and access pathways within the
current regulatory framework that balance early patient access, public
health and societal benefits. To afford patients faster access to innovative
medicines a fundamental and co-ordinated change is now required across
all elements of the bioscience sector, with collaboration and partnership
becoming a core capability for success. The requirements and expectations
for sustainable change will be discussed from various perspectives.
Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU
Gigi Hirsch, Executive Director, CBI and Program Director, NEWDIGS, MIT, USA
Yann Le Cam, CEO, EURORDIS, France
MAPPS: FOSTERING COLLABORATIVE MODELS FOR CLINICAL
DEVELOPMENT
Susanna Del Signore, Associate Vice-President Global Regulatory Affairs,
Head of Global Regulatory Policy, Sanofi R&D, France
Chris Chinn, VP and Head of Health Investment Evidence, GSK; Project
Coordinator IMI GETREAL

DISCLOSURE OF INFORMATION - WHAT WILL BE DISCLOSED
ACCORDING TO THE NEW SCHEME IN THE CLINICAL TRIALS
LEGISLATION?
Alexander Roediger, Director European Union Affairs, MSD (Europe) Inc.,
Belgium
The Clinical Trials Regulation requires that the EU database shall be publicly
accessible unless, for all or part of the data and information contained
therein, confidentiality is justified for certain reasons. Some factors that
may justify confidentiality is the protection of commercially confidential
information, the protection of confidential communication between
Member States in relation to the preparation of the assessment report and
the protection of personal data.
This session will take a closer look at the circumstances under which
confidentiality is justified as listed in Art. 81(4), in particular commercially
confidential information. It will also address the questions what constitutes
an overriding public interest in disclosure and which legitimate factors
from various stakeholders need to be taken into account? Finally, it will
put these requirements into the broader context, in particular regarding
EMAs Policy 70 On publication of clinical data for medicinal products for
human use.
The presentations/discussion will shed light on controversial issues and a
panel debate will follow.
The EMA Proposal The Agencys Attempt to Strike a Balance between
Disclosure and Protection of Clinical Trials Information
Ana Rodriguez, Head of Clinical and Non-Clinical Compliance, European
Disclosing Information about Clinical Trials- Where are the limits? The
Industry Research Perspective
Fabien Peuvrelle, Director, Clinical Trials and Labelling Translations Group,
Regulatory Affairs Europe, Celgene R&D, Switzerland
Public Access to Clinical Trials Data: The consumer perspective
Ilaria Passarani, Health Policy Officer, European Consumers Organisation
(BEUC), Belgium
To What Extent Will the European Citizen Benefit from the Clinical Trial
Information? Experiences from Empirical Research
Frederic Bouder, Associate Professor, Maastricht University, the Netherlands
24

EM0202 | Tuesday, 14 April, 11:00-12:30 | Room 241 Level 2
Theme 2
Medical Devices and
Combination Products
Paul Jansen, Global Head Medical Devices US, Sanofi, USA

Sabina Hoekstra-van den Bosch, Global Regulations and Standards,
Philips Healthcare, the Netherlands.
IMPACT OF THE REGULATIONS IN PRACTICE ACROSS REGIONS

Session Chair:
Michelle OConnor, Director Regulatory Consulting, Icon Clinical Research,
Ireland
Medical Devices Regulatory Pathways across the EU and US regions
Michelle OConnor, Director Regulatory Consulting, Icon Clinical Research,
Ireland
Ning Li, Vice President and Head, Asia/China Regulatory Affairs, Sanofi
The healthcare industry is increasingly embracing the opportunities

offered by medical devices, in vitro diagnostics combination products
and health information technology.
Medical Device Requirements in India

Daniel Verstappen, Vice President Quality & Regulatory Affairs Europe EAGM India, GE Healthcare, Belgium
This theme examines the trends in this rapidly evolving field. It will
examine the regulatory challenges posed by these novel combination
therapies, particularly the use of the biologics used in drug / device
combinations. It will also consider the regulatory aspects of how
information technology and health apps collect and use the data
generated by modern medical devices. How can we ensure we that
have a regulatory environment capable of reacting quickly to the needs
of this dynamic sector and maximizing its benefits for the patient? The
theme will also provide the latest news on the upcoming European
Medical Device Regulation and In Vitro Diagnostic Regulation,
highlight the latest trends in international medical device regulation
and analyse consequences of the future European legislative changes
for substance-based medical devices.

NEW MEDICAL DEVICE REGULATIONS IN THE EU
Session Chair:
Sabina Hoekstra-van den Bosch, Global Regulations and Standards, Philips
Healthcare, the Netherlands.
The Strengthening of the EU Medical Devices Regulatory System
Erik Hansson, Deputy Head of Unit, Health Technology and Cosmetics,
European Commission, EU
New Legislation on Medical Devices Update on progress and future
prospects
Graeme Tunbridge, Head of Medical Devices EU Policy, Medicines and
Healthcare Products Regulatory Agency (MHRA), UK
A Notified Bodys Perspective on the Impact on Stakeholders of the
Immediate Action Plan and the Proposed Medical Device Regulation
Neil Adams, Director Operations and Delivery, Medical Devices, BSI, UK
IMPACT OF THE REGULATIONS ON SUBSTANCE-BASED MEDICAL

DEVICES
Session Chair:
Miranda Moussa, Manager for Medical Devices, AESGP, Belgium
In light of the growing interest in substance-based medical devices across
Europe, the session will look into their particularities and consider ways
to ensure that safe, effective and innovative substance-based medical
devices continue to reach citizens. The latest European developments on
the proposed regulation on medical devices and their potential impact on
this category will be discussed.
A Notified Bodys Perspective on the Impact of the Proposed Medical
Device Regulation on Substance-based Medical Devices
Neil Adams, Director Operations and Delivery, Medical Devices, BSI, UK
Adjusting the Medical Device Legislation to Substance-based ProductsThe perspective of one competent authority
Judite Neves, Head of Medical Devices, Infarmed, Portugal
George Jessen, Member of the AESGP Committee on Medical Devices;
Regulatory Affairs Manager, Procter & Gamble, UK
EM0205 | Wednesday, 15 April 09:00-10:30 | Room 242 Level 2
NEW IVD REGULATIONS IN THE EU
Session Chair:
Jess Rueda Rodrguez, Regulatory Affairs Director, European Diagnostic
Manufacturers Association
MSdialog: A Novel System for Engaging Patients with Multiple Sclerosis in
Routine Health Outcomes Reporting and Monitoring
Mark Thristan, Associate Director, IS - R&D - Embedded IT, EMD Serono,
USA
View from a Notified Body
Catherine Holzmann, IVD department Manager, GMED Certification Division
25

Anticipation of the Coming Changes in the EU Regulatory Framework for

Companion Diagnostics
Sylvie Le Gledic, Director, IVD/CDx, Voisin Consulting Life Sciences, France
HEALTH APPS: DEFINITION, REGULATION & USE
Session Chair:
Erik Vollebregt, Partner, AXON Lawyers, the Netherlands
Erik Vollebregt, Partner, AXON Lawyers, the Netherlands
Brad Thompson, Member of the Firm, Epstein, Becker & Green
Pierre Leurent, CEO, Voluntis, France
CLINICAL, QUALITY & REGISTRATION CONSIDERATIONS FOR
BIOLOGICS COMBINATION PRODUCTS DEVELOPMENT
Session Chair:
Paul Jansen, Global Head Medical Devices US, Sanofi, USA
There are a growing number of Biologics in active development, many
of them in late stage development. This session will explore some of the
key considerations and unique challenges of gaining approval of Biologics
combination products.
EU/US Registration Dossier Challenges for Biologics/Device
Combinations
Marielle Fournier, Director, Combination and Borderline Products, Voisin
Consulting Life Sciences, France
Risk-Based Quality and Compliance Management in Clinical Trials with
Marina Malikova, Executive Director, Surgical Translational Research
Operations and Compliance, Boston University School of Medicine, USA
The EU Framework for Combination Products A Regulatory View
Christa Wirthumer-Hoche, Head, Austrian Medicines and Medical Devices
Agency, Austria
Theme 3
Advanced Therapies, Novel
Treatments for Rare Diseases
Paula Salmikangas, Chair CAT, Senior Researcher, Finnish Medicines

Agency (FIMEA), Finland
Henk Schuring, Group Vice President Regulatory Affairs - Europe,
Genzyme Europe B.V., the Netherlands
We now have five years of experience of the Advanced Therapy
Medicinal Products (ATMP) legislation. It is time to review whether this
legislation has met expectations. Has it produced the numbers and
effectiveness - of treatments expected? Although some products have
already reached patients, the success rate has been low and there have
been several issues over effectiveness.
This session will examine what we have learned from the ATMP
legislation and whether it now requires revision. Will the new regulatory
pathways developed for ATMP, such as adaptive licensing, change how
we approach drug development? What lessons have the work with rare
diseases and orphan drugs taught us, and how do we leverage those
insights more widely?

APPROVAL PROCESS AND EXPERIENCE TO DATE/CHALLENGES AND
SUCCESSFUL OUTCOMES OF ATMP DEVELOPMENT
Session Chair:
Beatriz Silva Lima, Advisory Board, NDA, UK
The progress on gene and cell therapies from regulation implementation
will be addressed from European perspective. The rapid knowledge
evolution will be illustrated with examples of products history from their
research until their current stage.
An Overview to MAA Process for ATMPs and CAT Experience from Five
First Years
Patrick Celis, Scientific Administrator, Committee for Advanced Therapies
(CAT) Secretariat, European Medicines Agency, EU
Commercially Viable Options for ATMP Manufacture
Klaus Maleck, CEO, TETEC AG, Germany
International Regulatory Co-Operation for ATMPs
Liz Anne Gillham-Eisen, A/Director, Health Products and Food Branch,
Health Canada, Canada
26


QUALITY ASPECTS FOR AN ATMP (M3 OF MAA)
Session Chair:
Valerie Pimpaneau, Voisin Consulting Life Sciences, France
The development of ATMP comes with a complex set of CMC challenges
that developers need to overcome in order to design an adapted control
strategy. The complex nature of cell and gene therapy products combined
with mode of actions that may not always be fully understood and often
involve multiple pathways lead to quality assessment approaches likely to
be unique to each product. This session will provide an overview of major
quality issues encountered during the development of cell based medicinal
products, discuss the difficulties encountered in developing potency assays
and the value of using risk assessment to support development choices and
quality assessment strategies.
Major Quality Issues for CBMPs
Margarida Menezes-Ferreira, Senior Assessor and National Scientific Advice
Coordinator, INFARMED, Portugal
The Challenges of Potency Assay Development of Cell and Gene Therapy
Product
Valerie Pimpaneau, Voisin Consulting Life Sciences, France
New Developments for GTMPs
Bastien Calmels, Quality Control Senior Manager, Transgene, France
ADAPTIVE LICENSING FOR ATMPS
Session Chair:
Hans Ovelgnne, Member SAWP, CAT; Medicines Evaluation Board,
the Netherlands
In March 2014 the EMA launched a pilot project into adaptive pathways.
The aim was to investigate a better use of real-world data in the licensing of
medicinal products, in conjunction with HTAs. Several companies submitted
products into this pilot, including a larger than expected proportion of
ATMPs. What is special about ATMPs?
ATMPs and the EMA Pilot Project on Adaptive Pathways
Hans Ovelgnne, Member SAWP, CAT; Medicines Evaluation Board, the
Netherlands
How to Meet Post-Marketing Obligations?
Maria Pascual, Vice President Regulatory Affairs and Corporate Quality,
Tigenix, Spain
ATMP REGULATIONS - ONGOING REVIEW
Session Chair:
Paula Salmikangas, Chair CAT, Senior Researcher, Finnish Medicines
Agency (FIMEA), Finland
With Regulation 1394/2007/EC the legal framework is now built for ATMPs
in EU. It has provided certainty and predictability for the development of
ATMPs and set the requirements for their authorisation. However, many
aspects of the legislation have been found problematic, as can be seen
from the results of the European Commission consultation concerning the
ATMP regulation and the subsequent EC report, published in April 1st, 2014.
The comments received and conclusions of the EC report call for revision of
the legislation, but what should be changed and how?
Need for Revision of the ATMP legislation?
Rocio Salvador-Roldn, Policy Officer, European Commission, EU
Bottlenecks for ATMP Development
Alex Bloom, Manager, Global Regulatory Affairs, Biotechnology & Advanced
Therapies, Chiesi Farmaceutici, Italy
Boundaries between ATMPs and Transplant/Transfusion Products,
Revision of Guidance on ATMP Classification
Marit Hystad, CAT member, Head of Section, Norwegian Medicines Agency,
Norway
ATMPS - CLINICAL TRIAL DESIGN CHALLENGES FOR ATMPS AND
MEDICINAL PRODUCTS FOR RARE DISEASES
Session Chair:
Gopalan Narayanan, Biologics & Advanced Therapies Expert, NDA Group,
UK
Many advanced therapy products are being developed to fulfil an unmet
medical need, particularly in the area of orphan diseases. This combination
of new technology and rarity of the disease(s) concerned can significantly
raise the challenges developers face in establishing positive clinical benefit.
However, the regulations, recognising these difficulties, offer sufficient
flexibility to enable successful development.
Regulatory Requirements for ATMP Clinical Trials
Gopalan Narayanan, Biologics & Advanced Therapies Expert, NDA Group,
UK
Clinical Study Designs and Possible Challenges for ATMPs
Etienne Sokal, Founder and CEO, Promethera Biosciences, Belgium
Statistical Considerations
Tomasz Burzykowski, Vice President, IDDI, Belgium
CHALLENGES FOR DEVELOPMENT OF RARE DISEASES
Session Chair:
Peter Bogaert, Advocaat, Convington & Burling LLP, Belgium
The orphan medicines regime in the EU is almost 15 years old and has
been a success. There remains, however, a need to develop new medicines
and other therapies that target rare diseases. The session will review the
challenges for effective development programmes and explore possible
routes for improvement.

Strategic View of a Regulator on Effective Development of Therapies for

Rare Diseases
Diederick Slijkerman, Head of Policy, Governance & Regulatory Affairs,
Medicines Evaluation Board (MEB), the Netherlands
Registries for Rare Diseases
Rengarajan Badri, President, Board of Directors, International Pemphigus
and Pemphigoid Foundation, USA
Experiences from Orphan Exclusivity in the EU
Peter Bogaert, Advocaat, Convington & Burling LLP, Belgium
27
claim public health value for their innovative products. Yet, regulation
that produces no or only limited net health benefit may stifle innovation,
disincentivise investors in R&D, and, most importantly, delay or deny
patients access to beneficial treatments. Focussing on diabetes drugs as an
illustrative example, this session will address how we can best find a level of
evidence standards that maximises both public health and economic value.
Panellists:
Andr Broekmans, Director, Escher (TI Pharma platform for regulatory
innovation), the Netherlands
Jean-Luc Harousseau, President, Haute Autorit de Sant (HAS), France
Yann Le Cam, CEO, EURORDIS, France
Theme 4
Early Dialogue with Regulators
and HTA Bodies on Innovative
Medicines
Isabelle Clamou, Regulatory Affairs Director EU Policy, Amgen,

Belgium
Zaide Frias, Head of Regulatory Affairs and Best Evidence, Head of
Human Medicines Research and Development Support (ad interim),
If innovative treatments are to reach patients quickly, manufacturers
need clarity and consistency in what to expect from regulatory
processes and Health Technology Assessments (HTAs). How can these
bodies cooperate and coordinate regularly?
This theme will examine the impact of recent activities by regulatory
and HTA bodies, and how it will affect approvals of new treatments.
What will be the consequences of new approval pathways on the
industry, and can we build on these to streamline processes? How
the delivery of new initiatives and both European and national level
change the regulatory environment?
It will also examine how to create constructive interactions between
stakeholders on core issues such as evidence standards, adaptive
licensing, lifecycle advice, patient involvement and EU collaboration
on HTAs.
Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, Medical Products

Agency, Sweden
EM0403 | Tuesday, 14 April, 14:00-15:30 | Room Havane Level 3
SHAPING EUROPEAN EARLY DIALOGUES: THE SEED PROJECT
Session Chair:
Franois Meyer, Advisor to the President, International Affairs, Haute
Authorit de Sant (HAS), France
SEED is a project funded by the European Commission involving 14
HTA bodies from 10 countries and coordinated by HAS (France). The
main objectives are: 1) the conduct of 10 early dialogues (ED) between
companies and HTA bodies on the development of new pharmaceuticals
and medical devices and 2) the proposal for a permanent model for ED
in Europe. The session will provide an update on the advancement of
the project and preliminary results, with discussion on the benefits and
potential challenges for the future of this activity.
Early Dialogues Involving Multiple HTA Bodies: Lessons learnt and future
challenges
Franois Meyer, Advisor to the President, International Affairs, Haute
Authorit de Sant (HAS), France
Early Dialogue and SEED Project: The perspective from a pharmaceutical
company
Luk Maes, Executive Director, Regulatory Scientific Policies Europe,
Bristol-Myers Squibb, Belgium
The European Commission Perspective
Jrme Boehm, Administrator / Policy Officer, DG Health- eHealth, Health
Technology Assessment, European Commission, EU
REGULATORY EVIDENCE STANDARDS: ARE WE MAXIMISING VALUE

GENERATION?
Session Chair:
LIFECYCLE OF REGULATORY/HTA ADVICE

Session Chair:
Spiros Vamvakas, Head of Scientific Advice, European Medicines Agency, EU
Good pharmaceutical regulation creates value, poor regulation destroys

value. This basic rule goes for public health value as well as for economic
value. The current business model of the bio-pharmaceutical industry is
predicated on robust regulation. Without regulation, there would be no
drug development as we know it, and sponsors would not be able to
This session will focus on the experience of the new approaches

of interaction among regulators, HTAs and companies during drug
development throughout the life-cycle of medicinal products. Furthermore,
the session will address new concepts currently under exploration of
approaching the lifecycle of medicinal products such as adaptive licensing
and post-authorisation efficacy studies.
28

State of the EMA Adaptive Pathways Pilot Project

Hans Ovelgnne, Member SAWP, CAT; Medicines Evaluation Board,
the Netherlands
EMA-HTA Scientific Advice
Judith Creba, Head EU Liaison and Policy, Novartis, Switzerland
HTA Perspective on Early Engagement in New models of Scientific Advice
Leeza Osipenko, Associate Direct, National Institute for Health and Care
Excellence (NICE), UK
EM0405 | Wednesday, 15 April 09:00-10:30 | Room Bordeaux Level 3
PATIENT INVOLVEMENT IN THE DEVELOPMENT DIALOGUE WITH
REGULATORY AUTHORITIES AND HTAS
Session Chair:
Isabelle Stckert, Head Global Regulatory Affairs Europe/Canada, Bayer
Pharma AG, Germany
Patient involvement in innovative drug development and access
considerations are hot topics; methodological work is rapidly evolving. The
session provides insight into latest research of EMA and IMI PROTECT on
patient value elicitation methodologies.
How Can Regulatory Authorities and HTAs Build on Patient Input - The
European Medicines Agency perspective
Francesco Pignatti, Head of Oncology, Haematology and Diagnostics,
The Patient Perspective in Drug Development
Franois Houyez, Treatment Information and Access Director, Health Policy
Advisor, EURORDIS, France
Patient and Public Involvement in Innovative Drug Development and
Benefit/Risk Decision Making What is state of the art after PROTECT
WP5?
Kimberley Hockley, Research Associate, Team Leader of the Patient and
Public Involvement Working Group in WP5 PROTECT), Imperial College, UK
EM0406 | Wednesday, 15 April, 11:00-12:30 | Room Havane Level 3
ONE-STEP APPROACH ON HTA ASSESSMENT, APPRAISAL AND PRICING
REIMBURSEMENT
Session Chair:
Jrme Boehm, Administrator / Policy Officer, DG Health- eHealth, Health
Technology Assessment, European Commission, EU
State of Play EUnetHTA
Speaker invited
Industry Perspective
Edith Frnoy, Director, Market Access/HTA, EFPIA, Belgium
Mapping of Existing Scheme
Neil McAuslane, Director, Centre for Innovation in Regulatory Science
(CIRS), UK

HTA AND ADAPTIVE PATHWAYS
Session Chair:
Sarah Garner, Associate Director R&D, NICE, UK
EMA Pilot on Adaptive Pathways: State of play and case study
Francesca Cerreta, Scientific Administrator, European Medicines Agency,
EU
Adaptive Approaches to Licensing HTA and the Use of Technology
Speaker invited
Please see EuroMeeting Extra for updates

Theme 5
Collaborative Consortia, IMI and
the Way to Horizon 2020
Salah-Dine Chibout, Global Head Discovery & Investigative Safety,

Global Head Preclinical Safety Therapeutic Areas, Novartis Pharma,
Novartis Institutes for BioMedical Research, Switzerland
Fatiha Sadallah, Principal Scientific Manager, Innovative Medicines
Initiative (IMI), Belgium
Evolutions in drug discovery are encouraging research-based
companies to be less introspective and explore new approaches to
drug development. Increasingly, they seek partnerships with multiple
stakeholders, including academia, small and medium-sized enterprises
and others, sharing knowledge and diversifying risk.
These collaborations may differ in their structure and approach.
However, all are based on the recognition that combining resources
will deliver outcomes exceeding those they could achieve individually.
This theme will examine how major stakeholders perceive these
collaborations, and will examine the future potential for new publicprivate partnerships (PPPs).

STRENGTHENING COLLABORATIVE INNOVATION AND MAXIMISING
MUTUAL BENEFIT: PHARMACEUTICAL INDUSTRY PERSPECTIVES
Session Co-Chairs:
Salah-Dine Chibout, Global Head Discovery & Investigative Safety, Global
Head Preclinical Safety Therapeutic Areas, Novartis Pharma, Novartis
Institutes for BioMedical Research, Switzerland
Will PPPs revive breakthrough innovation at the pharmaceutical industry?
Cross-private and public partners innovation entails distinctive innovation
opportunities and challenges because of the heterogeneity between the
collaborating parties. Such opportunities and risks will be discussed using
the example of IMI with strong and mature PPP networks in key areas of
R&D.
The U-BIOPRED (Unbiased BIOmarkers in PREDiction of Respiratory
Disease Outcomes) Severe Asthma Consortium - An Industry Perspective
Chris Compton, VP, Medicines Development Leader, GlaxoSmithKline, UK
Experiences from IMI
Matthias Gottwald, Head R&D Policy and Networking, Bayer, Germany
Excellence in RWD: GetReal and its benefit to industry
Melvin Olson, Health Economics Manager, Novartis, Switzerland
29

MINIMISING COSTS, HURDLES, AND DUPLICATION: HOW REGULATORS,
PAYERS AND POLICY MAKERS MAY PROFIT FROM PPPS
Session Chair:
Though PPPs might create a powerful mechanism for addressing difficult
problems by leveraging on the strengths of different partners, they also
package complex ethical and process-related challenges. Participation of
regulators, payers and policy makers warrants that topics addressed by
PPPs will be set within a comprehensive policy and operational framework.
The session will highlight interest in and potential legal/ethical conflicts
with PPPs of regulators, payers and policy makers.
Policy Maker Perspectives from the IMI GetReal Project
Sarah Garner, Associate Director R&D, NICE, UK
Collaborative Learning from the Regulatory System of Medicines: Recent
results from the Escher Project
Andr Broekmans, Director, Escher (TI Pharma platform for regulatory
innovation), the Netherlands
PPP: Beyond Publication - From scientific collaboration to regulatory and
medical practice and new business models
Magda Chlebus, Director, Team Leader, EFPIA, Belgium
IN BETWEEN: SMEs PERSPECTIVE ON PPPs
Session Chair:
Ruxandra Draghia-Akli, Director, Directorate Health, Directorate-General
for Research, European Commission
If I have seen further it is by standing on the shoulders of giants (Isaac
Newton, letter to Robert Hooke 15 Feb 1676). The relevance of PPPs for
the economic viability of SMEs will be discussed in this session.
SMEs as Success Factors for PPPs and Technology Transfer on the Example of the European Lead Factory
Dimitrios Tzalis, Founder and CEO, Taros Chemicals, Germany
SMEs in IMI Projects: A Management & Governance Perspective - Expected positive outcomes for consortia and SMEs (SAFE-T, MIP-DILI,
DDMoRe)
Nicolas Creff, Project Officer, Interface Europe, Belgium
30


DEVELOPING BEST PRACTICE GUIDANCE ON PATIENT ENGAGEMENT IN
MEDICINES R&D
Session Chair:
David Haerry, EUPATI Co-Leader on Sustainability (WP7), European AIDS
Treatment Group, Switzerland
EUPATI IMI is developing best practice guidance on patient engagement
with all relevant stakeholders (industry, ethics committees, health
technology assessment bodies and regulatory agencies). This session aims
to inform about the current status of the deliverable and to collect further
feedback from the audience.
Short introductory statements and Q&A on the present status of patient
involvement in the context of:
Industry-led R&D
Ethics Committees
HTA
Patient Involvement in Industry-Led R&D
Matthias Gottwald, Head R&D Policy and Networking, Bayer Pharma AG,
Germany
Patient Involvement in HTA
Karen Facey, Patient Involvement Methods and Impact Working Group
Coordinator, Health Technology Assessment International, UK
Patient Involvement in Ethics Committees
Andrea Heckenberg, Senior Staff Member, Ethics Committee Office,
Vienna Medical University, Austria
Patient Involvement in Regulatory Agencies
Isabelle Moulon, Head of Patients and Healthcare Professionals, European
Medicines Agency (EMA), EU
EM0506 | Wednesday, 15 April 11-12:30 | Room 243 Level 2
COLLABORATIVE INNOVATION IN BIOMEDICINE SERVING INDUSTRY,
ACADEMY AND SOCIETY
Session Chair:
Julio Celis, Professor and Associate Scientific Director, Danish Cancer
Society Research Center, Denmark
With the international recognition of the importance of innovation,
technology transfer, and entrepreneurship for sustained economic revival
and the decline of industrial research laboratories, research universities
often play a central role in collaborative discoveries, innovations, and
inventions. This session will discuss how the innovation ecologies at and
around universities are meeting this societal challenge.
Cancer Core Europe: Sustainable Capacity Building to Address the Cancer
Care-Research Continuum
Alexander Eggermont, Director General, Gustave Roussy, France
IMI - driven advances in diabetes
Beatriz Silva Lima, IMI SC Chair, University of Lisbon, Portugal
Pre-Competitive Gains from Data Sharing across Sponsors: The power of

big data and collaboration
Jonathan Rabinowitz, Bar-Ilan University, Israel
A PARTICIPATORY SOCIETY FOR A BETTER HEALTH: PATIENT, CITIZEN,
AND CONSUMERS VOICE IN PPPS
Session Chair:
Jan Geissler, Director, EUPATI, Belgium
The medical landscape is changing at a very fast pace. Particularly in areas
with strong unmet medical needs, new collaboration models between
all key healthcare players are essential to address these. In order to
create better health, researchers, industry, policy makers and regulators
increasingly understand the need to involve patients and citizens to make
research and healthcare provisioning more effective. This session will
provide an overview of the level of patient involvement across PublicPrivate Partnerships in the Innovative Medicines Initiative, and will provide
practical examples of projects where patient involvement has become
reality.
Empowering Patients in Medicines R&D for Better Health: The EUPATI IMI
project
Nicola Bedlington, Executive Director, European Patient's Forum, Belgium
Patient Involvement in IMI Public-Private Partnership: Strategy and
current status
Madga Gunn, Scientific Project Manager, IMI, Belgium
"How it Works" - 18 years of experience by the European Community
Advisory Board (ECAB)
David Haerry, European AIDS Treatment Group, Switzerland
PANEL DISCUSSION WITH PUBLIC-PRIVATE PARTNERSHIP
STAKEHOLDERS
Session Chair:
Fatiha Sadallah, Principal Scientific Manager, Innovative Medicines Initiative
(IMI), Belgium
PPPs a Trojan Horse of neoliberal development or an innovation
opportunity for all stakeholders? In this session we invite to a lively panel
discussion with all stakeholders to appreciate the mutual benefits and
drawbacks of PPPs.
Matthias Gottwald, Head R&D Policy and Networking, Bayer, Germany
Jan Geissler, Director, EUPATI, Belgium
for Research, European Commission, EU
Magda Chlebus, Director, Team Leader, EFPIA, Belgium
Isabelle Moulon, Head of Patients and Healthcare Professionals, European
Medicines Agency (EMA), EU

Theme 6
Implementing Innovation
Globally Conducive Regulatory
Policies
Jun Kitahara, International Liaison Officer stationed in Swissmedic,

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Henrik Kim Nielsen, Corporate Vice President, Regulatory Affairs GLP1 and Obesity, Novo Nordisk, Denmark
This theme examines developments in harmonising rules
internationally and how they can stimulate innovation by simplifying
global requirements. Do the concepts of regulatory convergence,
harmonisation and co-operation represent the reality? Is there a
role for the ICH and other harmonisation initiatives? What are the
developments in regulatory harmonisation in major Asian markets such
as Japan and China? It will also explore how increased harmonisation
can reduce costs and complexities in gaining approvals, speeding the
benefits of innovation to the patient globally.
EM0601 | Tuesday, 14 April, 09:00-10:30 | Room Maillot Level 2
ICH, IPRF, ICMRA: HOW ARE THESE INITIATIVES ADVANCING
REGULATORY HARMONISATION AND CONVERGENCE?
Session Chair:
Petra Drr, Head of Communication and Networking, Deputy Director,
Swissmedic, Switzerland
ICH, IPRF, ICMRA: How do all these initiatives play together? Can
duplication of efforts be avoided? What are the accomplishments so far
with regard to advancing regulatory harmonisation and convergence?
Reform of ICH
Lenita Lindstrm Gommers, EU Member ICH Steering Committee, Senior
Policy Officer, Unit 5D, European Commission, EU
A New Initiative among Regulators - The International Coalition of
Medicines Regulatory Authorities (ICMRA)
Nobumasa Nakashima, International Planning Director, for Pharmaceutical
Affairs, Ministers Secretariat, Ministry of Health, Labour and Welfare
Industry View on Different Regulatory Harmonisation Initiatives
Pr Tellner, EFPIA ICH Coordinator, Director, Team Leader, Regulatory
Affairs, EFPIA, Belgium
ASIA: CREATING POSSIBILITIES FOR CLINICAL DEVELOPMENT AND
COLLABORATION
Session Chair:
Toshiyoshi Tominaga, Associate Executive Director for International
Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
31
Asia is increasing its responsibility in worldwide pharmaceutical market,

because it is expanding its presence not only as a key market, but also as a
pharmaceutical manufacturing hub. Therefore, many Asian regulators make
strong efforts to accelerate the dealing with urgent issues such as capacity
building for their product review and safety monitoring, development of
guidelines for development of pharmaceuticals, etc.
This session contains the current situation of regulatory environment as well
as the recent achievements and challenges of Asian regulators, by focusing
on multi-regional clinical trials in Asia, followed by Q&A with the audience
to offer the opportunity to interact directly with Asian representatives to
consider how to facilitate regulatory development of innovative products.
Regulatory Perspective to Review MRCT Data for Drug Approval: Focusing
on ethnic factor evaluation
Yoshiaki Uyama, Director, Division of Epidemiology, Office of Safety I,
Pharmaceuticals and Medical Devices Agency, Japan
Efforts of MFDS for Facilitating Access to Medicines
Ho-Jeong Kim, Drug Review Management Division, Drug Evaluation
Department, National Institute of Food and Drug Safety Evaluation, MFDS,
Korea
Regional Heterogeneity in Multi-Regional Clinical Trials - Experiences
with regional health authorities
Jane Xu, Vice President, Data Science, Sunovion Pharmaceuticals, USA
CHINESE REGULATORY SESSION: UPDATE FROM THE CFDA
Session Chair:
Ning Li, Vice President Regulatory and Medical Policy, Asia Region, Sanofi,
China
Updates from two reports will be presented by the officials of Drug &
Cosmetics Registration Dept. and the Center for Drug Evaluation of the
China and Food Administration (CFDA). The progress of the ongoing
Reform of Drug Review and Approval System and the encouragement of
innovation, as well as the 2014 annual report of the drug technical review
will be discussed.
CFDAs Perspective on Clinical Trial Review for Drug Registration: Update
from CDE/CFDA
Wang Tao, Division Director, Center for Drug Evaluation, China Food and
Drug Administration, China
Issues and General Considerations of IND/CTA Applications in China
Wang Haixue, Chief Pharmacist, Center for Drug Evaluation, China Food
and Drug Administration, China
32


CHINA: OPPORTUNITIES AND CHALLENGES FOR INNOVATION
Session Chair:
Joseph Scheeren, Head of Global Regulatory Affairs Pharma and Consumer
Care, Bayer Consumer Healthcare, Switzerland
China has very complicated and dynamic regulatory policies in driving the
development of innovative new drugs. The session will elaborate on these
key regulatory policies and share experience on the regulatory aspirations,
barriers and opportunities that will impact global drug development and
availability of new medicines in China. How to optimize implementing
innovations within such an environment requires strategic considerations,
which this session aims to enlighten.
Understanding Regulatory Laws and Policies in China
Shaoyu Chen, Partner, Managing Director, Covington & Burling LLP, China
Quantifying the Chinese Regulatory Environment: Challenges and
Opportunities
Neil McAuslane, Director, Centre for Innovation in Regulatory Science
(CIRS), UK
An Overview of the Drug Development Landscape in China
Amar Kureishi, Vice President and Regional Chief Medical Officer, Head of
Drug Development Asia, Quintiles, Singapore
Science-Based Initiatives of PMDA

Tetsuo Nagano, Executive Director, Pharmaceuticals and Medical Devices
Agency (PMDA), Japan
New Streams of Risk Management
Tomiko Tawaragi, Chief Safety Officer, Pharmaceuticals and Medical Devices
Agency (PMDA), Japan
EM0607 | Wednesday, 15 April, 14:00-15:30 | Room Maillot Level 2
FROM THE SHOP FLOOR: PRACTICAL ADVICE ON BRINGING NEW
MEDICINES TO PATIENTS
Session Chair:
Henrik Kim Nielsen, Corporate Vice President, Regulatory Affairs GLP-1
and Obesity, Novo Nordisk, Denmark
Those working in industry present proposals from their daily experience for
improving and expediting safe and effective medicines to patients globally.
Strategies are presented for effective submission management processes
for global dossiers, in particular for emerging markets; possibilities for
trading molecules that have been shelved during development; and
creation of a Regulatory Compliance Matrix to simplify GMP submissions.
Submission Project Management Strategy: Coordinating Simultaneous
Global Submissions & Re-using Content for Future Emerging Markets
Submissions with a Focus on Latin America
Sophia Kourliouros, Senior Manager, Regulatory Submissions, Esai, USA

PMDA UPDATES: DISCUSSION OF LATEST PLANS AND NEW
DIRECTIONS IN REGULATION TOWN HALL
Session Chair:
Toshiyoshi Tominaga, Associate Executive Director for Office of
International Programs, Pharmaceuticals and Medical Devices Agency
(PMDA), Japan
In spring 2014, the Pharmaceuticals and Medical Devices Agency (PMDA)
developed the Third Mid-term Plan based on the results of the Second
Mid-term Plan, in which we achieved the shortened review time of new
drug approval, established a risk management plan, shortening the review
period of relief service, and established the structures for the promotion of
regulatory sciences. In the new plan, we will accelerate drug development,
especially for innovative ones, by improving the scientific quality of review,
consultation, and postmarketing safety measure through the regulatory
sciences such as the science board, advanced review/consultation system,
and other approaches.
This session contains the report for recent and future challenges of PMDA,
followed by Q&A with the audience to offer the opportunity to interact
directly with PMDA senior level representatives regarding almost all
services rendered by PMDA, including international programmes.
New Regulation in Japan and Future Direction of PMDA
Taisuke Hojo, Senior Executive Director, Pharmaceuticals and Medical
Devices Agency (PMDA), Japan
Collaborate to Innovate: Strategic alternatives towards developing a

seconds market
Doris Pereira, Assistant Manager, International Operations Department,
Torrent Pharmaceuticals, India
How to Meet Regulatory Challenges when Sourcing Biologicals from
Multiple Sites
Speaker invited
EMERGING MARKETS UPDATE: WHAT ON EARTH IS GOING ON WITH
REGULATOR CONVERGENCE?
Session Chair:
David Verbraska, Vice President, Worldwide Public Affairs & Policy, Pfizer,
USA
Identify successes and challenges in the rapidly evolving area of regulatory
harmonisation, particularly in the emerging markets. Understand the role of
WHO, public-private partnerships and the bio-pharmaceutical companies,
current initiatives and challenges.
Jaime Oliveira, Director Chairman, ANVISA, Brazil
Durhane Wong-Rieger, President and Chief Executive Officer, Canadian
Organization for Rare Disorders (CORD), Canada
Successes and Challenges of Regulatory Convergence: WHOs viewpoint
Lembit Rgo, Head, Regulation of Medicines and other Health Technologies,
World Health Organization (WHO), Switzerland

Theme 7
Special Development Pathways
in Paediatrics, the Elderly and in
Pregnancy
33
of conducting a global clinical trial in rare paediatric conditions. Leveraging

academic/industry partnerships and clinical trial networks are an efficient
way to share scientific and clinical information across geographic regions,
conduct comprehensive feasibilities to inform initial enrolment projections,
and provide ongoing feasibility to mitigate clinical trial conduct challenges.
New Mechanisms of Action - Changing the paradigm in paediatric drug
development
Sabine Atzor, Head of EU Regulatory Policies, F. Hoffmann-La Roche,

Switzerland
Jordi Llinares Garcia, Head of Product Development Scientific
Support, European Medicines Agency, EU
Children, pregnant women and the elderly have pose specific
treatment challenges. This is a highly charged and emotional interface
between science and society. Meeting these requires a dedicated
approach to drug development. This theme examines how we can
leverage scientific developments and define specific development
pathways to address these needs.
We will consider what we have learned since the Paediatric Regulation
was introduced ten years ago. How do we leverage the advances in
science since then to make further improvements?
We will also examine the health demands of an ageing population,
where new treatments are struggling to keep pace with Europes
demographic change. How can we bridge to their unmet needs more
quickly?
Medicine use during pregnancy remains a scientific, ethical and
regulatory challenge for researchers. How do we address this
specific need, and can broader, multi-stakeholder approaches make
a difference?
WHAT WILL THE FUTURE BRING INNOVATIVE PAEDIATRIC
DEVELOPMENT
Session Chair:
Nathalie Schultze, Regulatory Affairs Team Leader, F. Hoffmann-La Roche,
Switzerland
Despite obvious phenotypic differences, increasing evidence demonstrates
that adult and paediatric diseases may share similar molecular determinants
of disease occurrence and progression. Pursuing a disease-centred,
rather than drug-centred approach, allows a change in emphasis from
adult indications with paediatric counterparts to diseases in children with
greatest unmet need based on the mechanism-of-action and therapeutic
target of a molecule. While the current era of targeted therapies and
personalised medicine has created the opportunity to change the
paradigm of paediatric drug development, clinical trials in rare paediatric
conditions remains a major challenge. Accurate projection of recruitment
rates and successful accrual of patients in paediatric trials is often difficult
due to the limited number of cases, the absence of historical data of
paediatric patients participating in clinical trials, and logistical challenges
What are Innovative Trends? An industry perspective

Nathalie Schultze, Regulatory Affairs Team Leader, F. Hoffmann-La Roche,
Switzerland
Regulators Approach to Enable Innovation
Koenraad Norga, Head of Clinic Paediatric Oncology, PDCO member,
Belgium
Clinical Trial Networks as Enablers to Overcome Challenges with
Paediatric Clinical Trials
Irmgard Eichler, Professor of Paediatrics, Scientific Administrator, European
Panel Discussion: What navigation is needed by industry and regulators to
ensure childrens early access to innovative medicines?
HOW WILL THE GLOBAL NEEDS OF PAEDIATRIC DEVELOPMENT BE
ADDRESSED?
Session Chair:
Dirk Mentzer, Chair of PDCO; Head of Pharmacovigilance Unit, PaulErhlich-Institut (PEI), Germany
Eight years after the implementation of the Regulation EU 1901/2006 =
Paediatric Regulation, this piece of legislation has drastically changed
the way the Pharmaceutical Industry is considering the development of
new candidate medicinal products for children. Pharmaceutical industry,
investigators and patients are aware that newly developed medicinal
products are formulated and tested in children and it is expected to
increase in the coming years.
Of course the needs of the paediatric population is not restricted to the
Europe. In addition, a considerable number of medicinal products are
developed and manufactured by multi regional acting pharmaceutical
industry. Therefore, it is important to harmonise the paediatric study
program in each region to limit the number of paediatric clinical trial
needed to bring the medicinal product to the market. At the same time
guidance documents should facilitate the framing of medicinal product
development across the regions.
In this respect, Europe, US and Japan and FDA have commenced activities
for updating the ICH guideline E11 with the support of all regions involved.
This is to support the equal opportunities for child health in all regions.
The Next Era of ICH Paediatric Guidelines
Dirk Mentzer, Chair of PDCO; Head of Pharmacovigilance Unit, Paul-ErhlichInstitut (PEI), Germany
34

How is Convergence on Timing between EU-US Possible?

Irmgard Eichler, Professor of Paediatrics, Scientific Administrator, European
Optimising EMA Advice on Development and Putting the Patient First

Francesca Cerreta, Scientific Administrator, European Medicines Agency
(EMA), EU
Which Other Areas Would Benefit from Convergence how successful

have we been to date?
Jane Mll Pedersen, Global Regulatory Director, Novo Nordisk, Denmark
How Does Industry Address the Needs?

Susanna Del Signore, Associate Vice-President Global Regulatory Affairs,
Head of Global Regulatory Policy, Sanofi R&D, France
Panel discussion with: Sabine Fuerst-Recktenwald, Senior Medical Director

Pediatric Oncology, F. Hoffmann-La Roche, Switzerland - Solange Rohou,
Director Global Regulatory Affairs, AstraZeneca, France - Stephen Spielberg
Editor-in-Chief, Therapeutic Innovation & Regulatory Science, DIA, USA
Are Patients Convinced their Expectations are Met?

Barbro Westerholm, AGE Platform Europe, Belgium
HOW TO OVERCOME CHALLENGES IN THE DEVELOPMENT OF MEDICINES TO TREAT DEMENTIA

Session Chair:
Karl Broich, President, BfArM, Germany
MODELLING AND SIMULATION IN PAEDIATRICS:

THE NEXT STEP- KEEPING THE MOMENTUM
Session Chair:
Solange Rohou, Director, Global Regulatory Affairs, AstraZeneca, France
The 2011 EFPIA/EMA workshop was a unique event bringing together
scientists from academia, industry and regulatory agencies from Europe
and beyond to take an in depth look at the role of Modelling & Simulation
(M&S) in drug development. Since then, both regulators and industry
representatives have kept the momentum. This session will be the
opportunity to understand the status of this discussion, the work done so
far, and share some learnings. Case examples will be also presented for
discussion to show how extrapolation/M&S can be used to support drug
development in children and labelling claim.
The EMA Modelling and Simulation Working Group A strategic enabler
to further support PIP development
Efthymios Manolis, Scientific Officer, European Medicines Agency, EU
Good Practices in Model Informed Drug Discovery & Development (MID3)
Marylore Chenel, Director of Clinical PK and PMx, Institut de Recherches
Internationales Servier, France (on behalf of the EFPIA M&S group)
From Theory to Practice - Case examples
Amy Cheung, Senior Clinical Pharmacometrician, AstraZeneca, UK (on
behalf of the EFPIA M&S group)
Panel discussion
THE SILVER GENERATION - HOW DOES DEVELOPMENT ADDRESS THEIR
NEEDS?
Session Chair:
Francesca Cerreta, Scientific Administrator, European Medicines Agency
(EMA), EU
The European population is rapidly aging, with over 80s being the fastest
growing population group. This session will provide an update on the EMA
latest regulatory activities with respect to the assessment of the Benefit/
Risk balance in the older population, including the progress on the Frailty
Points to Consider and the guideline on packaging and formulations,
together with the perspective of industry and patients on addressing the
needs of the older population.
Can We Overcome Development with Set-Backs? Outcome of EMA

Alzheimer Workshop
Karl Broich, President, BfArM, Germany
Considering Bioethical Aspects in Development
Xavier Carne, Head of Clinical Pharmacology Department, Hospital Clinic,
University of Barcelona School of Medicine, Spain
Industry s Learning Curve - answering to challenges
Luc Truyen, Vice President, Clinical Research & Development, Johnson &
Johnson, USA
Panel discussion
50 YEARS AFTER THALIDOMIDE DEVELOPING DRUGS IN PREGNANCY
Session Chair:
Jordi Llinares Garcia, Head of Product Development Scientific Support,
Despite the urgent need, the development of products for use in pregnant
women is one of the most challenging situations clinicians, patients,
developers and regulators can encounter. Nevertheless the daily reality
is that in most cases pregnant women have to be treated without a clear
understanding of the effects on the drugs on the woman and the fetus. The
session will offer the opportunity to discuss the needs for regulatory and
development progress in this area and an overview of current initiatives.
Defining the Boundaries of the Current Regulatory Framework
Jordi Llinares Garcia, Head of Product Development Scientific Support,
How Does Industry Translate Experiences into a Way Forward?
Lode Dewulf, Vice President, Chief Patient Affairs Officer at UCB, Belgium
Clinical, Ethical and Socioeconomic Considerations An analysis in
epilepsy, rheumatoid arthritis and schizophrenia
Victoria Tzouma, Market Access Manager, MSD, Greece

Theme 8
Translational Medicine and
Regulatory Science
Anna Cielik, Director Department of Documentation Assessment,

Office for Registration of Medicinal Products, Poland
Detlef Niese, Consultant, Dr. Niese Health Science and Policy,
Germany
Regulatory science is essential in bringing the benefits of therapeutic
innovation to patients. It systematically analyses existing regulatory
frameworks, ensuring they evolve to keep pace with scientific
advances. This provides a dual benefit of promoting innovation whilst
protecting public health.
However, regulatory science faces a new challenge. An understanding
of how diseases operate a molecular or cellular level is replacing our
traditional disease definition based on phenotypes and symptom
descriptions.
This theme explores how existing regulations will need to adapt to
recognise these new definitions. It also examines the consequences
of these new approaches, particularly in clinical trials and the role of
clinical end points versus molecular end points. How will regulatory
science help drive this change? We harness the views of scientists,
regulators and patients in looking at the implications, implementation
and likely benefits of this change.

THE ROLE OF TRANSLATIONAL MEDICINE IN THE FUTURE OF LIFE SCIENCE
Session Chair:
Dariusz ladowski, Associated Professor, Medical University Warsaw,
Committee for Advanced Therapies (CAT) Representative, Poland
Translational medicine is a discipline bridging biomedical and public health
research to improve and speed up the process of practical implementation
of novel scientific achievements. The session will bring together the issues
of knowledge network which seems crucial for the better use of clinical
trials data which are about to be released by the EMA, the prospects of
innovative biomarkers and a problem of new technologies assessment
from the point of view of a regulator. It will focus on the future of university,
enterprise and regulatory scientists integration, in the translation process
of a new ideas into practical medicine.
Precision Medicine and the Evolving Role of Clinical Research and
Development
Claudio Garutti, Senior Consultant, Oracle Health Sciences, the Netherlands
35
Precision Medicine and the Evolving Role of Clinical Research and

Development
Joel Haspel, Senior Marketing Strategist, Oracle, UK
Diagnostic and Pharmacodynamic Biomarkers and Mass Spectrometry
Assays Thereof: Current status and perspectives
Harald Mischak, Institute of Cardiovascular and Medical Sciences, University
of Glasgow, UK
CAT View of the Role of Translational Medicine in the Future of Life
Science
Dariusz ladowski, Associated Professor, Medical University Warsaw,
Committee for Advanced Therapies (CAT) Representative, Poland
IS THE CLASSIFICATION OF DISEASE ON PAR WITH THERAPEUTIC
INNOVATION?
Session Chair:
Detlef Niese, Consultant, Dr. Niese Health Science and Policy, Germany
This session will address the role of ATC/DDD system for drug utilisation
research to improve the harmonisation of regulatory decisions.
A Mechanism-Based Disease Taxonomy: Need or hype?
Detlef Niese, Consultant, Dr. Niese Health Science and Policy, Germany
A New Disease Taxonony: A view from academia
Rolf Bass, University of Basel, Switzerland
THE RISK-BASED APPROACH FOR NEW MEDICINES DEVELOPMENT:
FROM ATMPS TO "CONVENTIONAL" DRUGS
Session Chair:
Beatriz Silva Lima, Professor, University of Lisbon, Portugal
The risk-based approach (RBA) for the safety assessment of ATMPs
consists on product-based risk anticipation followed by confirmation,
rather than risk observation followed by mechanistic understanding. Will
predictive science allow using the RBA to study conventional drugs safety?
Quality Aspects
Tobias Ostler, Senior Manager Scientific Affairs Biopharmaceuticals/
Immunologist, Dr. Regenold GmbH, Germany
Clinical Aspects
Andrea Laslop, Head of Scienific Office, AGES, Austria
Non-Clinical Aspects
Beatriz Silva Lima, Professor, University of Lisbon, Portugal
36

DIAGNOSTIC AND PHARMACODYNAMIC BIOMARKERS AND MASS

SPECTROMETRY ASSAYS THEREOF: CURRENT STATUS AND
PERSPECTIVES
Session Chair:
Pierre Marquet, Professor of Clinical Pharmacology, University of Limoges,
France
TRANSLATING REGULATORY APPROVAL INTO HEALTHCARE UPTAKE:

THE NEXT CHALLENGE FOR BIOSIMILARS
Session Chair:
Virginia Acha, Executive Director Research, Medical and Innovation,
Association of the British Pharmaceutical Industry, UK
Proteomics, peptidomics and metabolomics are considered to be sources

of potential biomarkers of disease or drug response in many clinical
areas, including organ transplantation and such biomarkers are already
well advanced towards clinical practice. In this session we will present
examples of protein, lipid and metabolite biomarkers, together with the
mass spectrometry assays involved; the regulatory paths for approval of
biomarkers, as well as mass spectrometry assays in Europe.
Protein and Metabolite Biomarkers of Graft Injuries in Renal Transplantation
Pierre Marquet, Professor of Clinical Pharmacology, University of Limoges,
France
Mass Spectrometry as a Routine Clinical Diagnostic Technique
Olof Beck, Adjunct Professor, Division of Clinical Pharmacology, Department
of Laboratory Medicine, Karolinska Institute, Sweden
Regulatory Issues in Clinical Biomarkers and Mass Spectrometry Assays
in Europe
Harald Mischak, Institute of Cardiovascular and Medical Sciences, University
of Glasgow, UK
CLASSIFICATION OF MEDICINAL PRODUCTS - FACTORS AFFECTING
REGULATORS DECISIONS, IS HARMONISATION POSSIBLE AND
NECESSARY?
Session Chair:
Hubertus Cranz, Director General, AESGP, Belgium
The session will look into the change of classification status from
prescription to non-prescription by paying particular attention to the
challenges for a successful application in the centralised procedure. Recent
experiences will be reviewed and proposals for future improvements will
be discussed.
Moving Emergency Contraception to Non-Prescription Status
Helen Guillard, Director, Self-Care Medicine, HRA Pharma, France
How to Make the Centralised System Work Better for Non-Prescription
Medicines
Mark Griffiths, Senior Director, Pfizer Consumer Healthcare, UK
Panel Discussion with all speakers,
Viola Macoli arini, Head of Agency, Agency for Medicinal Products and
Medical Devices (HALMED), Croatia, and
Tomas Salmonson, Chair CHMP, Senior Scientific Advisor, Medical
Products Agency, Sweden
This session will explore the gap that now remains is the translation from
regulatory assessment and approval to incorporation of biosimilars within
our healthcare systems in Europe. Presenters will offer new insights on
how to bridge this gap.
Mind the Gap: Setting out the translational challenges for biosimilars in
healthcare settings
Virginia Acha, Executive Director Research, Medical and Innovation,
Association of the British Pharmaceutical Industry, UK
Translating from Approval to Uptake The experiences of the first
biosimilar mAb in Europe
Paul K. Audhya, Vice President, Medical Affairs EMEA, Hospira, UK
Bridging the Gap for Hospital Pharmacist
Arnold Vulto, Hospital pharmacist, University Hospital Rotterdam, the
Netherlands
Bridging the Gap for Hospital Pharmacist
Richard Sullivan, Director of the Institute of Cancer Policy and KHP
Integrated Cancer Centre Global Health Work, Kings College London
Bridging the Gap for Patients
Alison Lightbourne, Policy Manager, International Alliance of Patients
(IAPO), UK
Incorporating the Patient Perspective into Clinical Decision Making in
Type 2 Diabetes
Matthew Reaney, Senior Scientist, ERT, UK
37


REGULATORY SCIENCE- NEW PARTNERSHIPS
Session Chair:
Per Spindler, Director, Biopeople, University of Copenhagen, Denmark
Regulatory Science in relation to medicines development has been a
field of growing interest for regulators and the pharmaceutical industry
for a number of years. The shaping and implementation of legislation and
guidelines are recognised as having a significant impact on public health
as well as R&D of medicinal products. Current concepts of benefit/risk
assessment, patient involvement and the regulatory pathways are being
challenged and new ideas are being launched by the pharmaceutical
industry, patient organisations and regulatory authorities. Universities are
increasingly contributing with research projects, educational projects, and
collaborations to make regulatory science a research-driven contribute to
regulatory decision-making. The universities possess expertise not only
within the traditional disciplines of medicines research and development
but also with other disciplines such as law and pharmacoeconomics.
New approaches from universities might indeed open doors for new
perspectives to be explored and new partnerships to be formed. Examples
are plenty such as transparency, patient involvement, definition of unmet
medical needs, methodologies in clinical research, licensing and health
economics. This session will show that research and educational initiatives
in universities offer a plethora of opportunities for new cross-sectorial
partnerships to be created and it will headlight the important role of
academia in setting the trends.
Patients Perspective
Industry Perspective
Merete Schmiegelow, Novo Nordisk A/S, Denmark
Academic Perspective
Karin Friis Bach, Research Assistant, Faculty of Health and Medical Sciences,
University of Copenhagen, Denmark
Authority Perspective
Panel discussion with all speakers and moderators Karin Friis Bach and Per
Spindler
Theme 9
Big Data, Mobile Health
Luca Pani, Director General, Italian Medicines Agency (AIFA), Italy

Duane Schulthess, Managing Director, Vital Tranformation, Belgium
Harnessing Big Data to make better, quicker medical decisions is a
logical development. However, this demands a delicate balance
between individual patient rights and the wider public good.
This theme explores how to reconcile these issues to maximise the
benefits offered by harnessing available health data. How can Big
Data improve patient outcomes and accelerate clinical development?
What are the implications of data ownership, and what will be the role
of social media in healthcare?
EM0901 | Tuesday, 14 April | 09:00-10:30 | Room 242 Level 2

eHEALTH: PUTTING INFORMATION TO WORK
Session Chair:
Jillian Oderkirk, Senior Analyst, Health Division, Organisation for Economic
Cooperation and Development (OECD), France
There is a wide agreement that system wide Electronic Health Records and
Electronic Heath Management systems have the potential to fundamentally
change the way we currently evaluate new therapies and manage
treatment pathways. However, many institutions and governments are
leery of proceeding, aware of the many failed and expensive EHR system
implementations that have gone wrong and not delivered their expected
results. This session will feature and demonstrate several successful 'best
in breed' eHealth platforms that focus on divergent parts of the healthcare
value chain to harness medical data for improved decision making,
efficiency gains, and better patient outcomes.
A Road Map for New Care Models in the 21st Century
Brian Rothman, Medical Director Informatics, Vanderbilt University Medical
Center, USA
Using National Health Records to Speed Development
Tim Williams, Head of Research, Clinical Practice Research Datalink (CPRD),
MHRA, UK
eHealth UK
Georgina Evans, Industry Manager, Farr Institute of Health Informatics
Research, UK
38


GOING MOBILE: DISRUPTIVE TECHNOLOGY AT YOUR FINGERTIPS
Session Chair:
Sten Stovall, The Pink Sheet, European Bureau Chief, Informa Business
Intelligence, UK
Bakul Patel, who heads the FDAs initiatives on Mobile Health (mHealth)
strategy, describes their potential as "taking care of patients 100% of the
time. While many governments and healthcare systems are focused on
large-scale national and regional health IT projects, mHeatlh is a catchas-catch-can of Angry Birds disruptive innovation that can fundamentally
change the way manage patient care and outcomes. This session will
investigate how companies, governments and industry are addressing
the challenges and opportunities of mHealth, and are integrating it into
strategy and policy.
Big Data Analytics Revolutionising Real Life Evidence Journey across the
Pharma Value Chain - challenges and opportunities
Dinesh Singh, Senior Manager- Business Consulting, Cognizant Technology
Solutions, UK
SOCIAL MEDIA, PATIENTS AND PUBLIC POLICY
Session Chair:
Alastair Kent, Director General, Genetic Alliance UK
mHealth for Patient Recruitment in Global Clinical Trials

Matthew Stumm, Corporate Promotion and Lead Generation, BBK
Worldwide, USA
As information becomes increasingly democratised, the barriers between

confidential data and public information are becoming increasingly blurred.
There are many examples of patients sharing information on clinical
research, promising new therapies, and locations of trials, but where
does this cross a line into impacting the impartiality of the research and
regulatory process? How can policy makers, patients, practitioners and
researchers harness social media tools for better stakeholder engagement,
while not impacting the need for some health information to remain
confidential as part of the research process?
Integrating mHealth Into National Healthcare Decision Making

John Eaglesham, CEO, Advanced, Digital Health Institute, UK
Using Social Media Tools to Change the Nature of Research

Ifty Ahmed, Founder and CEO, Pow Health, UK
Connected, Continuous & Coordinated: How mobile delivers connected

therapies that improve outcomes & powers business models
Gene Dantsker, Director of Business Development, Qualcomm Life, USA
The EPF's View of Social Media


BIG DATA: MOVING BEYOND BUZZ WORDS TO RESULTS
Session Chair:
Luca Pani, Director General, Italian Medicines Agency (AIFA)
Big Data world is invading the field of life sciences. Research organisations,
pharma companies as well as policy makers should be prepared to manage
this enormous amount of information and all the knowledge changes that
will be derived from it at a global level. This approach can lead to a better
and more accurate definition of several diseases and to the development of
monitoring activities and targeted responses.
"From the world to a water pump: this is the story of John Snow who
mapped all the cases of typhus fever in the 19th century using the London
city map. He could find that the center of the epidemic was indeed in a
water pump and was able to stop it. Since then Big Data analysis became
more sophisticated and as people are sharing more and more information
future scenarios are even now hard to imagine...
Simplifying Clinical Research and Cost-Effective Trial in the Era of Big
Data
Candida Fratazzi, President, Boston Biotech Clinical Research, USA
Metadata Management at the Core of Big Data Management
Isabelle de Zegher, Worldwide Director, Clinical Data Standards, PAREXEL
informatics, Belgium
Perspectives on Stakeholder Engagement in Regulatory Intelligence

Activities
Carolyn Hynes, Head of Global Regulatory Intelligence, GlaxoSmithKline,
UK
WHO OWNS MY HEALTH DATA?
Session Chair:
Who has the right to use patient data, and who gets to decide how it's
used? The European Parliament in March of 2014 overwhelmingly voted
for a data protection policy that could limit the use of existing health
databases without an opt-in by patients, but the US has an approach to
data that allows institutions to harness their captured medical information
as long as that usage falls within established confidentiality guidelines.
What are the implications if health data is not allowed to be harnessed as
easily in Europe as it is in the US and increasingly, Asia? What is the correct
path forward to make sure data is harnessed to provide the best patient
outcomes, but confidentiality is preserved?
This session will include four 15-minute presentations on patient data and
an open discussion of the impact of data usage and policy
39

Harnessing Patient Data to Develop New Therapies

John Parkinson, National Institute for Cardiovascular Outcomes Research,
UK
Who Owns My Data? Data Protection When Faced with Terminal Illness
Bettina Ryll, Founder, Melanoma Patient Network Europe, Uppsala
University, Sweden
EU Health Data and Research
Nathalie Kayadjanian, Senior Scientific Officer, Science Europe
Balancing the Need for Data Protection and Securing the Public Good
for Research, European Commission
REAL WORLD EVIDENCE FOR MEDICINES ADAPTIVE PATHWAYS TO
PATIENTS (MAPPS)
Session Chair:
Chris Chinn, VP and Head of Health Investment Evidence, GSK; Project
Coordinator IMI GETREAL
After nearly a decade of discussion, analysis and development, Medicines
Adaptive Pathways to Patients (MAPPs) is beginning to see acceptance
from regulators, industry and payers with the first live adaptive pilot project
under the guidance of the European Medicines Agency (EMA) in 2014. A
key plank of adaptive licensing is the ability to harness data in real time to
measure and capture an expanding evidence base. What are the current
frontiers and best practices of real world evidence, and how it incorporate
into new clinical pathways and accelerated decision making while insuring
data quality and security?
Harnessing Real World Evidence
Jonathan Cave, Departement of Economics, University of Warwick, UK
Optimising Patient- Centricity through Multilingual Social Intelligence
Liesl Leary, Director, Social Intelligence & Solutions, SDL, UK
Opt-in, Opt-out, & Patient Led Databases. Better Patient Outcomes,
Faster and Cheaper
Theme 10
Innovation in Vaccine
Development
Richard Pilsudski, Vice President Global Regulatory Affairs, Sanofi

Pasteur, France
Jan Willem van der Laan, Department of Pharmacology, Toxicology
and Biotechnology (FTBB), Medicines Evaluation Board, the
Netherlands
Vaccines play an increasingly important role in delivering global public
health. They offer a rapid and highly cost-effective way to reduce the
global disease burden, with an untapped potential for many more
benefits.
This theme explores current and future trends in vaccine development.
How do we balance the needs of supplying essential vaccines to the
developing world whilst maintaining innovation? What regulatory
pathways will support these differing needs? How do we harmonise
regulation to speed access where it is most needed?
ADAPTIVE PATHWAYS AND PATIENT ACCESS MODELS TO INNOVATIVE
TREATMENTS: IS IT APPLICABLE TO THE DEVELOPMENT OF VACCINES?
Session Chair:
Michel Stoffel, Vice-Chair Vaccines Europe, Belgium
Current considerations on how adaptive pathways (also referred as
Medicine Adaptive Pathways to Patients) could streamline the research,
licensing and market access processes have mainly focused on drugs and
patients. Vaccines Europe Regulatory Affairs Working Group initiated a
reflection to test the applicability of such adaptive pathways to vaccines,
and would like to open up a debate with main stakeholders in this field such
as regulators, payers/providers.
Adaptive Pathways and Patient Access Models to Innovative Vaccines: A
view from the industry
Steve Lockhart, Vice President, Development, Sanofi Pasteur-MSD, France
Adaptive Pathways and Patient Access Models to Innovative Vaccines: A
view from the regulator
Marco Cavaleri, Head of Anti-infectives and Vaccines, European Medicines
Agency, EU
Viral Challenge Studies: An innovative way to speed up the vaccine
development: An influenza case study
Bruno Speder, Head Clinical Regulatory Affairs & Document Management,
SGS Life Science Services, Belgium
40


VACCINE DEVELOPMENT ACROSS REGIONS
Session Chair:
Franoise Rey, Regulatory Policy and Intelligence, Sanofi Pasteur, France
The vaccine development is a long and very complex process that could
last up to 20 years before risk benefit of a new vaccine could be confirmed.
It involves a combination of investigators, volunteers, health authorities,
scientific experts and international organisations across all regions of
the world. The recent development of vaccines against Polio disease will
illustrate the development of new ways of working and interacting between
Sponsors, National Health Authorities, World Health Organization and
Public Private Partnership such as GAVI Alliance. The theme will explore
whether it is possible to further harmonize global development across
regions.
Global Regulatory Collaboration in the Framework of Polio Eradication
Fotula Fegaras, , Global Regulatory Affairs Franchise Head, Sanofi Pasteur,
Canada
The Role of IPV in a Post-Polio World
Sona Bari, Senior Communications Officer, WHO, Switzerland
Polio Endgame: Opportunities for collaboration
Keith Chirgwin, Deputy Director, Regulatory Affairs, Bill & Melinda Gates
Foundation, USA
Registration, Regulation and Practice in China
Li Maozhong, Deputy Director, Department of Drug and Cosmetics
Registration, China Food and Drug Administration, China
NEW AVENUE FOR NON-CLINICAL REGULATORY SCIENCE
Session Chair:
Bhazine Combadire, Director of Research, Head of Immunity and Vaccination
team, INSERM, Center for Immunology and Microbial Infection, France
On February 2010, the FDA launched its Advance Regulatory Science (ARS)
Initiative on groundbreaking efforts to transform the way medical products
are developed, evaluated, and manufactured on the basis of development of
new tools, standards, and approaches to assess the safety, efficacy, quality,
and performance of drugs and vaccines. The example of new technologies
allowing to forecast different vaccine responses before clinical trials are
conducted and to provide predictive in vitro immunological models and
assays will be presented. Acceptance of such innovative technologies by
European regulatory agencies will be discussed.
Innovation in Methods of Vaccine Administration and Immune Efficacy
Bhazine Combadire, Director of Research, Head of Immunity and
Vaccination team, INSERM, Center for Immunology and Microbial Infection,
France
Bioengineering in vitro Models of Human Immunity: Science Fiction or
Science Fact?
William Warren, Vice President, Head of VaxDesign Campus, USA
Advancing Vaccine Non-Clinical Testing by Harnessing New TechnologiesA regulators view

Yuansheng Sun, Senior Reviewer, Viral Vaccine Section, Paul-EhrlichInstitut (PEI), Germany
ADJUVANTS IN VACCINES
Session Chair:
Jan Willem van der Laan, Department of Pharmacology, Toxicology and
Biotechnology (FTBB), Medicines Evaluation Board, the Netherlands
The last decade several vaccines have reached the market with new
adjuvants. Issues have been raised about their safety, e.g., in relation to
autoimmunity. The WHO took the initiative of writing a guideline on the
non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines. With
this experience and new insights on the impact of Toll-like receptors on
the immune responses, an update of the regulatory testing was needed,
preferably from a global perspective. New adjuvants are still under
development.
Safety of Vaccine Adjuvants with Focus on Autoimmunity: HESI
workshop report
Heather Davis, Vaccines Research, Pfizer, Canada
WHO Guideline on Adjuvanted Vaccines
Biotechnology (FTBB), Medicines Evaluation Board, Netherlands
Regulatory Strategy for Non-Clinical Safety Assessment to Support
Malaria Candidate
Micaela Damsten, Manager, Nonclinical Toxicology, Global Regulatory
Affairs, GSK Vaccines, Belgium
BIOVACSAFE (IMI PROJECT)
Session Chair:
David JM Lewis, Imperial College London, UK
BIOVACSAFE is a 30M, 5 year Innovative Medicines Initiative project with
20 partners including industry (GSK, Sanofi Pasteur, Novartis Vaccines,
deCODE), academia and SMEs. It integrates human clinical experimental
medicine studies with animal models and large cohorts of adults and
children to identify biomarkers associated with vaccine reactogenicity
and immunosafety. A systems biology, bioinformatics and cross-species
approach is pursued, together with careful clinical characterisation of
adverse reactions following immunisation.
BIOVACSAFE: Translational Medicine and Systems Biology to Identify
Biomarkers of Vaccine Reactogenicity
David JM Lewis, Imperial College London, UK
Questing for Early Markers of Safety: A circular approach
Giuseppe Del Giudice, Global Head Translational Medicine, Novartis
Vaccines, Italy
41


NEW DEVELOPMENTS, EBOLA VACCINES
Session Co-Chairs:
Richard Pilsudski, Vice President Global Regulatory Affairs, Sanofi Pasteur,
France
Biotechnology (FTBB), Medicines Evaluation Board, the Netherlands
Theme 11
Availability of Medicinal
Products: Drug shortages
The Ebola epidemic in African countries put a huge challenge to public

health authorities how to cope with it. Existing programs developing
vaccines are enhanced to shorten the time to reach clinical stages. New
vaccine strategies have to reach maturity in a short time frame.
Beln Escribano Romero, Head of Department, Pharmaceutical

Inspection and Enforcement Department, Spanish Medicines Agency
(AEMPS), Spain
Pr Tellner, Team Leader, Regulatory Affairs, EFPIA, Belgium
Accelerated Development of a Heterologous Prime Boost Approach

Combining Ad26.ZEBOV and MVA-BN-FILO
Benoit Callendret, Compound Development Team Leader, Janssen (Crucell),
the Netherlands
Shortages of medicinal products are an increasingly problem

globally. Although there are many causes of shortages issues
of manufacturing, supply, quality and commercial viability the
consequences are inevitably on patients.
rVSV-ZEBOV-GP Vaccine: Development Update and Regulatory

Considerations
Geert Preuveneers, Merck Sharp & Dohme, Belgium
Regulatory Activities Related to Ebola Vaccines EMA perspective
Marco Cavaleri, Head of Anti-infectives and Vaccines, European Medicines
Agency, EU
This theme examines ways to address this problem. It will set out
why preventing drug shortages needs to be a priority and explores
the steps that regulators can take to protect patients. How do we
encourage the broad cooperation between regulatory authorities
inside and outside Europe that can help reduce shortages and limit
their impact when they do occur?

SOME BASICS ABOUT SHORTAGES OF MEDICINAL PRODUCTS:
CONCEPTS, CAUSES, SITUATION AND TRENDS
Session Chair:
Beln Escribano Romero, Head of Department, Pharmaceutical Inspection
and Enforcement Department, Spanish Medicines Agency (AEMPS), Spain
Shortages are increasing and have a negative impact mainly for patients
but also for the industry and the regulatory authorities. In this session we
will try to establish the basic concepts about shortages, taking into account
different perspectives of the problem. Shortages concept, classification
and their root causes as well as trends will be presented. These basic
discussions will help us to progress towards the other sessions of this
theme: shortages consequences, solutions and future scenario.
Basics about Shortages, Supply Chains and Quality
Domnico Di Giorgio, Director of the Counterfeit Prevention Unit, Italian
Medicines Agency, (AIFA), Italy
EFPIA Good Practices for Drug Product Shortages
Birgitte Holst, Quality Intelligence Director, Novo Nordisk, Denmark
Medicines Shortages, Supply Chains and Quality
Stephen Spielberg Editor-in-Chief, Therapeutic Innovation & Regulatory
Science, DIA, USA
42

EM1104 | Tuesday, 14 April, 16:00-17:30 | Room 352B Level 3
SHORTAGE CONSEQUENCES: THEIR IMPACT oN PATIENTS, HEALTH

CARE PROFESSIONALS AND REGULATORS
Session Chair:
Pr Tellner, Team Leader, Regulatory Affairs, EFPIA, Belgium
LOOKING AT THE FUTURE OF SHORTAGES OF MEDICINAL

PRODUCTS
Session Chair:
Brendan Cuddy, Scientific Administrator, Manufacturing and Quality
Compliance European Medicines Agency, EU
At this session we are focusing on consequences of shortages.

Representatives for healthcare professionals and patients are - based on
their experience - describing what could happen when it is not possible to
deliver the medicinal products. A media representative is also giving their
view on the level of transparency regarding shortages in Europe and the
challenges to inform the public about this serious issue.
Consequences of shortages HCP perspective
Roberto Frontini, President, European Association of Hospital Pharmacists,
Healthcare Professionals Working Group, Germany
Consequences of Shortages Patient perspective
Franois Houyez, Health Policy Officer, EURORDIS, France
Consequence of Shortages Press perspective
Sten Stovall, The Pink Sheet, European Bureau Chief, Informa Business
Intelligence, UK
SOLVING AND PREVENTING SHORTAGES / COMMUNICATION BETWEEN
DIFFERENT STAKEHOLDERS
Session Chair:
Shortages of Medicinal Products as a Result of Quality Defects or GMP
Non-Compliance
Brendan Cuddy, Scientific Administrator, Manufacturing and Quality
Compliance European Medicines Agency, EU
Recommendations to Address Shortages
Franois Houyez, Health Policy Officer, EURORDIS, France
Industry Communication Principles to Authorities
Julie Marechal, Senior Manager Quality & Regulatory Affairs, European
Generics Association (EGA), Belgium
NCA Perspective
Proposals to Decrease the Problems with Shortages in the Future
Franois Bouvy, Director Market Access, EFPIA (European Federation of
Pharmaceutical Industries and Associations), Belgium
Panel discussion with speakers and Beln Escribano Romero, Roberto
Frontini, Franois Houyez and Sten Stovall

Theme 12
Pharmacovigilance in 2015 Poised for convergence of
innovation
43
Post-approval Safety Surveillance: FDA Perspective

Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, Food and
Drug Administration (FDA), USA
The Good, the Bad and the Ugly of Patient Safety Data Sources
Sue Rees, Executive Director and EU QPPV, Global Patient Safety, Amgen,
UK
Maarten Lagendijk, Pharmacovigilance Coordinator, Medicines

Evaluation Board (MEB), the Netherlands
Maria-Grazia Zurlo, QPPV, Pfizer, Italy
Harnessing the Power of Emerging Data and Technologies: Balancing

qualitative and quantitative needs in safety surveillance
Andrew Bate, Senior Director, Epidemiology Group Lead, analytics,
Worldwide R&D, Pfizer Ltd., UK
The 2010 European Pharmacovigilance Legislation has converted

many of the concepts and approaches of pharmacovigilance into
practical applications. Whilst refinement of this process continues,
it already provides a system that promotes patient safety whilst
remaining proportionate.
Will Social Media Aid Decision Making in Pharmacovigilance? Look Before

You Tweet
David J. Lewis, Global Head of Pharmacovigilance, Novartis Pharma,
Switzerland
This theme reviews the important learnings in pharmacovigilance to

date, and what role it plays in stimulating innovation. It will examine
which principles and technologies are driving change. How should
these new insights and new approaches affect the way we consider
risk benefit? Should risk benefit be applied in the same way for new
and established treatments?
We will also look at PRAC (Pharmacovigilance Risk Assessment
Committee) and its impact on approaches to safety. How is
participation between bodies changing, nationally and internationally
and how do we improve this process? We also explore the role of
patients in pharmacovigilance; how has their role changed, and are we
giving them the right information to participate fully?
EM1201 | Tuesday, 14 April | 09:00-10:30 | Room Bordeaux Level 3

PHARMACOVIGILANCE DEBATE: BRAVE NEW WORLD OF DECISION
SUPPORT
Session Chair:
Paul Eisenberg, Senior Vice President of Global Medical and Chief Medical
Officer, Amgen, USA
Evidence-based drug safety decisions must be made as early as possible,
often with incomplete, missing, or misleading data. ICSRs historically
have had a major role in this process and there have been increased
efforts to gather more detailed data for ICSRs, although the impact that
would have on patient safety is unclear. The digital age has ushered in
new possibilities for additional data streams. This session will consist of a
debate centered around pragmatic approaches to quality decision making
in pharmacovigilance: Should the focus be on gathering more detailed data
for ICSRs? Should intelligent signaling systems be developed to analyse
electronic health records and social media data? Can intelligent signaling
applied to digital data be used to augment traditional ICSR-based system
to more rapidly reach acceptable decisions in pharmacovigilance? Where
should we apply future efforts and investment?
Signal Detection in an EMR Healthcare Environment: Danish experience

Mona Vestergaard Laursen, Senior Adviser, Danish Health and Medicines
Authority, Denmark
EM1202 | Tuesday, 14 April, 11:00-12:30 | Room Bordeaux Level 3
PHARMACOVIGILANCE: HOW WELL ARE PATIENTS INFORMED AND
HOW CAN THEY CONTRIBUTE?
Session Chair:
Vicki Edwards, QPPV and Head of Affiliate Vigilance Excellence, Abbvie, UK
Current EU legislation and guidance encourage patients to engage the
pharmacovigilance system by reporting safety concerns. Are they doing
so? Regulated communication of patient-centric safety information must
be conveyed in lay terms, which should give consideration to individual
understanding, translatability, and cultural and other communication
issues. Given the communication channels currently available to patients, a
portion of this session will explore whether the new legislation has had an
impact on the value of this information to patients, i.e., is there evidence
of improved patient comprehension, retention, and behavior regarding
the safe and proper use of medicinal products? Another segment of this
session will be devoted to patient engagement in safety and whether
this has begun to contribute to the evolving body of safety information
in EudraVigilance? Are there additional opportunities for two-way
communication with patients, particularly for citizens who have difficulty
understanding and using health information?
Pharmacovigilance and Patient Information - What's new?
Theo Raynor, Professor of Pharmacy Practice, University of Leeds, UK
The Patient Information Gap
Phil Willan, Patient Representative, Healthcare Quality Improvement
Partnership (HQIP), Member of the Outcomes Publication Advisory Group,
UK
Using Patient Insights to Improve Safety Management
Michael Richardson, VP International GPV&E and EU QPPV, Bristol-Myers
Squibb, UK
44

INTERNATIONAL COLLABORATIONS IN PHARMACOVIGILANCE:

COMMON OBJECTIVES, COMMON CHALLENGES
Session Chair:
Peter Arlett, Head of Pharmacovigilance, European Medicines Agency, EU
IS IT OFF-LABEL USE OR MEDICATION ERROR INTO THE UNKNOWN?

Session Co-Chairs:
June Raine, Vigilance and Risk Management of Medicines Division, MHRA,
UK
Carla Schoonderbeek, Partner, Hoyng Monegier, the Netherlands
Pharmacovigilance is a global enterprise and regulatory science is

constantly evolving globally to meet new scientific challenges, particularly
those with common objectives. As a result, a patchwork of agreements
amongst regulatory authorities has evolved that permit confidential
data exchange across jurisdiction and the ability to share perspectives
on common objectives and challenges. This session will cover current
collaboration between EMA and FDA in pharmacovigilance. Focus will be
on drug-specific scientific evaluations, new pharmacovigilance tools, and
how regulators address common challenges in the context of legislative
constraints.
Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, CDER,
FDA, USA
Val Simmons, EU QPPV, Executive, Global Patient Safety, Eli Lilly and
Company Ltd., UK
GVP Annex I defines ADRs, off-label use, medication errors, and misuse.
Specific MedDRA terms are available to code these medical concepts, but,
based on available information, term selection for coding may not always be
obvious. This session will address regulatory expectations and challenges
in applying these definitions for ICSRs and implications for PSURs. Focus
will be on practical and legal aspects of categorising, monitoring, and
assessing medication errors, misuse, and off-label use and how to identify
and implement opportunities to prevent them.
The Challenges and Pitfalls of Off-Label and Other Unlicensed Use of
Medicines
Alexander Meier, Global Head Legal Regulatory & Development, Novartis
Pharma AG, Switzterland
How the Expanded Definition of AE is Helping Pharmacovigilance
Georgy Genov, Head of Signal Management, Division Inspections and
Human Medicines Pharmacovigilance, European Medicines Agency (EMA),
EU

BENEFIT/RISK - PRAGMATIC LIFECYCLE MANAGEMENT
Session Co-Chairs:
June Raine, Vigilance and Risk Management of Medicines Division, MHRA,
UK
Valerie Simmons, EU QPPV, Executive, Global Patient Safety, Eli Lilly & Co.,
Ltd, UK
The benefit/risk profile of a medicinal product must be favorable to gain
and maintain marketing authorisation. From a pragmatic view, however,
different approaches and proportionality are needed to assess and
manage the benefit-risk balance across a products lifecycle in a resourceappropriate manner. This session will address practical aspects of benefitrisk management from First-In-Human studies through late-cycle product
maturation. Different lines of evidence, challenges in their evaluation,
and triggers for PASS and PAES will be discussed in a pragmatic context,
considering both patient safety and the changing realities of data across a
products lifecycle.
How is the Regulatory Framework Helping?
Peter Arlett, European Medicines Agency, EU
Will the New PROTECT Tools Make a Difference?
Shahrul Mt-Isa, Imperial College UK
Assessment of Benefit/Risk in the Lifecycle of Biologics
Isma Benattia, Vice President Global Safety, Amgen, USA
Panel Discussion with all speakers and Tomas Salmonson, Chair CHMP,
Senior Scientific Advisor, Medical Products Agency, Sweden
Making the Pharmacy an Even Safer Place to Get Medicines

John Chave, Secretary General EU pharmacist organization PGEU
Panel discussion with Rob Camp, EURORDIS, France
EM1206 | Wednesday, 15 April, 11:00-12:30 | Room Bordeaux Level 3
MANAGING THE RISK OR MANAGING THE PLAN?
Session Chair:
Maarten Lagendijk, Pharmacovigilance Coordinator, Medicines Evaluation
Board (MEB), the Netherlands
Harmonisation of RMPs (Risk Management Plans) across different
regulatory jurisdictions, including triggers for RMP updates, is challenging
due to discordant perceptions of true risk and the availability, burden, and
effectiveness of various minimisation interventions. The RMP is a living
document; as more and more information on a product becomes available
during its lifecycle risks can change. However, removing risks can especially
be a challenge and in this session a possible method is discussed. Preparing
an RMP for mature products gives rise to challenges, and several practical
issues to effectively manage RMPs for generics, such as multiple divergent
assessments, developing a RMP when the reference products has none,
etc. exist as well. In the session plans to streamline the process will be
discussed.
RMPs for Generics
Kora Doorduijn, CMDh member/Policy adviser, Policy, Governance and
Regulatory Affairs Department, Medicines Evaluation Board (MEB), the
Netherlands
45

RMPs for Mature Products

Wendy Booth, Director, Global Clinical Safety & Pharmacovigilance,
GlaxoSmithKline, UK
Are Risks Written in Stone? Strategies to Successfully Remove Risks from
Risk Management Plans
Samuel Ramsden, Safety Surveillance Risk Management Specialist, Novo
Nordisk, Denmark
SIGNAL DETECTION AND MANAGEMENT: CAN YOU WHISTLE?
Session Chair:
Phil Tregunno, Signal Management Unit Manager, MHRA, UK
The session will present signal detection recommendations from the
collaborative Innovative Medicines Initiative (IMI) PROTECT Project and
discuss the key principles of signal management in the EU. Over the course
of the past 5 years, IMI PROTECT has conducted research across multiple
partners to explore various aspects of statistical signal detection. Its results
are already beginning to shape changes in the approach to signal detection
within the EU Network. This session will provide a whistle-stop tour of those
recommendations, and key principles for signal management in the EU.
Introduction to PROTECT Research and Recommendations for Statistical
Signal Detection
Antoni Wisniewski, Analytics Systems Lead, AstraZeneca, UK
Choice of Granularity for Statistical Signal Detection: When and how to
group adverse events
Niklas Norn, Chief Science Officer, Head of Research, Uppsala Monitoring
Centre, Sweden
Statistical Signal Detection for Spontaneous Reports: Which method to
use?
Suzie Seabroke, Senior Epidemiologist, Medicines and Healthcare Products
Regulatory Agency (MHRA), UK
The Signal Management Process in the European Pharmacovigilance
Network - key principles, transparency, process optimisation, and
interface with stakeholders
Georgy Genov, Head of Signal Management, European Medicines Agency,
EU

PRAC: HIGHLIGHTS, CHALLENGES AND REFERRALS
Session Co-Chairs:
Sarah Montagne, Head of EU Regulatory Policy, Bayer, UK
Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board,
the Netherlands
More than two years after the inauguration of PRAC, PV legislation remains
high on everyones agenda and has fundamentally changed the way safety
related activities are conducted in the EU.
There has been a major shift from a predominately reactive system
to a proactive lifecycle benefit/risk management approach using risk
management plans (RMPs), post-authorisation safety studies and real-time
signal detection. Whilst managing this shift, PRAC has devoted a significant
part of its time conducting safety referrals, often on well-established
products.
The consequence of a proactive risk management system in the postmarketing environment has seen increased levels of activity and complexity
not previously experienced within the EU.
A panel discussion including Industry and regulators will consider some
of the key challenges and latest hot topics in this area. Three short
presentations will be made to set the scene: PRAC highlights, impact of
PASS, and lessons learn on safety referrals for well-established products.
PRAC: Highlights from a busy agenda
Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board, the
Netherlands
The Impact of Imposed PASS and the Challenges of Making Multi-MAH
Studies Work
Katarina Nedog, Safety and Regulatory Manager, European Generic
Medicines Association (EGA), Belgium
Union Safety Referrals: Shared experiences of the referral journey for wellestablished products and the importance of effective communication
Emmanuelle Pines, Head of Corporate Pharmacovigilance Division, Pierre
Fabre Medicament, France, on behalf of AESGP
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HOT TOPICS/STAND ALONE SESSIONS

EM1302 | Tuesday, 14 April | 11:00-12:30 | Blue Room Level 2
ESSENTIAL BUSINESS CHANGE MANAGEMENT IN PHARMACOVIGILANCE: SYSTEMS, SERVICES AND SIMPLIFICATIONS
Session Chair:
The coming months will see the launch of the EMA literature monitoring
service for the industry, piloting of the PSUR repository for centralised
document submission, the Article 57 database of products and substances
in full maintenance mode and significant progress made in the development
of new functionalities for the EudraVigilance system for collecting and
analysing reports of suspected adverse drug reactions. All these services
and systems will impact industry and regulators and informed business
change management will allow the improved data and information to be
utilised while realising efficiency gains for the industry. The session will set
out the scope of the imminent change and explore the impact on different
industry stakeholders.
Scope and Benefits of Business Change in Pharmacovigilance
Impact of New Systems and Services on Innovative Industry Sector
Margaret Walters, Director & Deputy EU QPPV, MSD, UK
Impact of New Systems and Services on Generics Sector
Wendy Huisman, EU QPPV, Teva Pharmaceuticals Europe., the Netherlands
Discussion on Impact on Industry
Elmar Kroth, Managing Director, German Medicines Manufacturers
Association (BAH), Germany
EM1305 | Wednesday, 15 April 09:00-10:30 | Room Havane Level 3
PHARMA MEDICAL AFFAIRS: VISION THROUGH 2020
Session Chair:
Gustavo Kesselring, President IFAPP; DIA Advisory Council of Latin
America; Executive Director Latin America, ViS Research, Brazil
Medical affairs organisations have emerged over the past half century
in response to federal regulations around the separation of medical and
commercial activities within drug companies. Many companies also
chose to focus R&D resources on developing new products and moved
post-launch activities, such as finding new indications for existing drugs,
into the medical affairs function. Continued pressure from regulatory
agencies and public sentiment have pushed more and more activities
into Medical affairs organisations. Today, these organisations commonly
involve the following medical activities: Medical education, medical field
teams, post-launch clinical trials, medical-information services, medical
communications, medical strategic activities and health economics and
outcome research activities. The vision from medical departments of three
global pharmaceutical companies will be addressed and balanced with the
vision of the Standing Committee of the European Doctors (CPME).
Michael Devoy, Head, Global Medical Affairs & Pharmacovigilance; Member

of the Executive
Committee and Chief Medical Officer, Bayer HealthCare AG, Germany
Jacques de Haller, Vice President, Standing Committee of European
Doctors (CPME), Switzerland
Michael Rosenblatt, Executive Vice President and Chief Medical Officer,
Merck & Co., Inc, USA
Tamas Suto, Chief Medical Officer, Sanofi Asia, China
50 YEARS OF EDQM: PREPARING FOR THE FUTURE TO CONTINUOUSLY
ENSURE THE QUALITY OF MEDICINES
Session Chair:
Susanne Keitel, Director, EDQM/Council of Europe
The European Directorate for the Quality of Medicines and HealthCare
(EDQM) turned 50 in 2014. While EDQM and its 37 Member States are proud
of the tremendous achievements over the past 50 years, globalisation and
technical and scientific developments in all fields pose constant challenges.
The session will provide an insight to EDQMs activities, and focus on current
hot topics such as the introduction of finished product monographs in the
European Pharmacopoeia, the impact of Quality by Design (QbD), recent
developments in pharmacopoeial harmonisation, the holistic strategy in
combating counterfeit medicines and the establishment of a harmonised
European paediatric formulary of unlicensed medicines.
Finished Product Monographs and Current Hot Topics of the European
Pharmacopoeia
Cathie Vielle, Head of the European Pharmacopoeia Department, EDQM/
Council of Europe
QbD and the Pharmacopoeia
Graham Cook, Sr. Director, Global Quality Intelligence and Compendial
Affairs, Pfizer
An Update on Pharmacopoeial Harmonisation
Susanne Keitel, Director, EDQM/Council of Europe
The EDQMs Holistic Anti-Counterfeiting Strategy
Franois-Xavier Lery, Head of Section, EDQM/Council of Europe
Paedform A Harmonised European Paediatric Formulary
Dirk Leutner, EDQM/Council of Europe

47
FOCUS SESSIONS
Focus on Quality
Focus on Adaptive Pathways
Session 1101 | Tuesday, 14 April, 09:00-10:30
Session 0106 | Wednesday, 15 April, 11:00-12:30
SOME BASICS ABOUT SHORTAGES OF MEDICINAL PRODUCTS:

CONCEPTS, CAUSES, SITUATION AND TRENDS
Session Chair: Beln Escribano Romero, Head of Department,
Pharmaceutical Inspection and Enforcement Department, Spanish
Medicines Agency (AEMPS), Spain
MEDICINES ADAPTIVE PATHWAYS TO PATIENTS (MAPPS) - HOLDING

HANDS ACROSS THE LIFECYCLE
Session Chair: James Anderson, Head of Corporate Government Affairs,
GlaxoSmithKline, UK

QUALITY ASPECTS FOR AN ATMP (M3 OF MAA)
Session Chair: Valerie Pimpaneau, Voisin Consulting Life Sciences, France
HTA AND ADAPTIVE PATHWAYS

Session Chair: Sarah Garner, Associate Director R&D, NICE, UK

SOLVING AND PREVENTING SHORTAGES/ COMMUNICATION BETWEEN
DIFFERENT STAKEHOLDERS
Session Chair: Lidia Retkowska-Mika, Director, Legal Department, Office
for Registration of Medicinal Products, Poland
NEW AVENUE FOR NON-CLINICAL REGULATORY SCIENCE
Session Chair: Bhazine Combadire, Director of Research, Head of
Immunity and Vaccination team, INSERM, Center for Immunology and
Microbial Infection, France
IMPACT OF THE CLINICAL TRIAL REGULATION ON CMC FILING AND
RELEVANT GMP REQUIREMENTS
Session Chair: Georges France, Global LOC Quality lead, GlaxoSmithKline,
UK
50 YEARS OF EDQM: PREPARING FOR THE FUTURE TO CONTINUOUSLY
ENSURE THE QUALITY OF MEDICINES
Session Chair: Susanne Keitel, Director, EDQM/Council of Europe
FROM THE SHOP FLOOR: PRACTICAL ADVICE ON BRINGING NEW MEDICINES TO PATIENTS
Session Chair: Henrik Kim Nielsen, Corporate Vice President, Regulatory
Affairs GLP-1 and Obesity, Novo Nordisk, Denmark
REAL WORLD EVIDENCE FOR MEDICINES ADAPTIVE PATHWAYS TO

PATIENTS (MAPPS)
Session Chair: Chris Chinn, VP and Head of Health Investment Evidence,
GSK; Project Coordinator IMI GETREAL
Focus on Patient Involvement

Monday, 13 April, 13:30-15:00
EU REGULATORY TOWN HALL MEETING
50th Anniversary of the EU Pharmaceutical Legislation
Moderator: Fernand Sauer, French Academy of Pharmacy, Former
Executive Director of the European Medicines, France
Session 0405 | Wednesday, 15 April 09:00-10:30
PATIENT INVOLVEMENT IN THE DEVELOPMENT DIALOGUE WITH
REGULATORY AUTHORITIES AND HTAS
Session Chair: Isabelle Stckert, Head Global Regulatory Affairs Europe/
Canada, Bayer Pharma AG, Germany
DEVELOPING BEST PRACTICE GUIDANCE ON PATIENT ENGAGEMENT IN
MEDICINES R&D
Session Chair: David Haerry, EUPATI Co-Leader on Sustainability (WP7),
European AIDS Treatment Group, Switzerland
SOCIAL MEDIA, PATIENTS AND PUBLIC POLICY
Session Chair: Alastair Kent, Director General, Genetic Alliance UK

CLINICAL, QUALITY & REGISTRATION CONSIDERATIONS FOR BIOLOGICS COMBINATION PRODUCTS DEVELOPMENT
Session Chair: Paul Jansen, Global Head Medical Devices US, Sanofi, USA
Session 0507 | Wednesday, 15 April 14:00-15:30

A PARTICIPATORY SOCIETY FOR A BETTER HEALTH: PATIENT, CITIZEN,
AND CONSUMERS VOICE IN PPPS
Session Chair: Jan Geissler, Director, EUPATI, Belgium
48

SPEAKER INDEX
Last Name
First Name
Session
Page Number
Acha Virginia
EM0807
36
Adams
Neil
EM0201, EM0204
24
Ahmed
Iftakhar (Ifty)
EM0906
38
Anderson
James
EM 0106
Arlett
Peter
EM1203, EM1204, EM1302
44, 46
Atzor
Sabine
EM0103, Theme 7
22, 33
23
Audhya Paul
EM0807
Backman Christer
EM0104
22
Bari Sona
EM1002
40
Bate Andrew
EM1201
43
Beck Olof
EM0805
Bedlington
EM0507, EM0808, EM0906
Nicola
36
36
30, 36, 38
Benattia Isma
EM1204
44
Bloom Alexander
EM0305
26
Boehm
EM0403, EM0406
Jrme
27, 28
Bogaert Peter
EM0308
26
Booth Wendy
EM1206
44
Bouder Frederic
EM0108
23
Bouvy Franois
EM1104
42
Broekmans Andr
EM0503
29
Broich Karl
EM0706
34
Brosch
EM Tutorial 1
16
Burzykowski Tomasz
EM0306
26
Callendret Benoit
EM1008
41
Calmels Bastien
EM0302
26
Camp Rob
EM1205
44
Cavaleri
EM1001, EM1008
Sabine
Marco
39, 41
Cave Jonathan
EM0908
Celis Patrick
EM0301
39
25
Celis Julio
EM0506
30
Cerreta
Francesca
EM0407, EM0705
Charmeil
Olivier
Opening Plenary
28, 34
21
Chave John
EM1205
44
Chen Shaoyu
EM0604
32
Chenel Marylore
EM0703
Cheung
Amy
EM Tutorial 6, EM0703
Chibout
Salah-Dine
34
18, 34
Theme 5, EM0501
29
Chinn Chris
EM0908
39
Chirgwin Keith
EM1002
Chlebus
Magda
EM0505, EM0508
Clamou
Isabelle
40
29, 30
Theme 4
27
Combadire Bhazine
EM1004
40
Compton Chris
EM0501
29
Cook Graham
EM1306
46
Cranz Hubertus
EM0806
36
Creba Judith
EM0404
28
Creff Nicolas
EM0504
29
Cuddy
EM1103, EM1104
42
Brendan
49

SPEAKER INDEX
Last Name
First Name
Session
Dal Pan
Gerald
EM1201, EM1203
Damsten Micaela
EM1006
Danan
Gaby
Page Number
43, 44
40
EM Tutorial 1
16
Dantsker Gene
EM0903
38
Davis Heather
EM1006
40
De Cuyper
Xavier
EU Town Hall Meeting
20
De Haller
Jacques
EM1305
46
de Zegher
Isabelle
EM0904
38
Del Giudice
Giuseppe
EM1007
40
Del Signore
Susanna
Theme 1, EM0107, EM0705
22,23,34
Devoy Michael
EM1305
46
Dewulf Lode
EM0708
34
Di Giorgio
EM1101
41
Doorduijn Kora
EM1206
44
Drr Petra
EM0601
Draghia-Akli
EM0504, EM0508, EM0907
Domenica
Ruxandra
31
29, 30, 38
Eaglesham John
EM0903
38
Edwards Vicki
EM1202
43
Eggermont Alexander
EM0506
Eichler
Hans-Georg
EM0106, EM0402, EM0503
Eichler
Irmgard
EM0701, EM0702
Eisenberg Paul
EM1201
Escribano Romero
Theme 11, EM1101, EM1104
Beln
30
23, 27, 29
33, 34
43
41, 42
Evans Georgina
EM0901
37
Facey Karen
EM0505
30
Fegaras Fotula
EM1002
40
Fournier Marielle
EM0208
25
Fratazzi Candida
EM0904
38
Frnoy Edith
EM0406
28
Friis Bach
Karen
EM0808
36
Frontini
Roberto
EM1102, EM1104
42
Gandhi
Shelley
EM Tutorial 5
Garner
Sarah
EM0407, EM0503
17
28, 29
Garutti Claudio
EM0802
35
Geissler
Jan
EM0507, EM0508
Genov
Georgy
EM1205, EM1207
Gillham-Eisen
Liz Anne
EM0301
25
Giorgi
Dominique
Satellite Symposium
20
Gottwald
Matthias
EM0501, EM0505, EM0508
30
44, 45
29, 30
Griffiths Mark
EM0806
Guillard Helen
EM0806
36
Gunn Magda
EM0507
30
Haerry
Opening Plenary, EM0505, EM0507
21, 30
David
Hansson Erik
EM0201
Harousseau
Satellite Symposium, EM0402
Jean-Luc
36
24
20, 27
Heckenberg Andrea
EM0505
Hellbert
EM Tutorial 2
16
EM0106
23
Karina
Hirsch Gigi
30
50

SPEAKER INDEX
Last Name
First Name
Session
Page Number
Hockley Kimberly
EM0405
28
Hoekstra-van den Bosch
Theme 2, EM0201
24
Hojo Taisuke
EM0605
32
Holst Birgitte
EM1101
41
Holzmann Catherine
EM0205
24
Houyez
EM0405, EM1102, EM1103, EM1104
Sabina
Franois
28, 42
Huisman Wendy
EM1302
Hurts
Opening Plenary
21
Hynes Carolyn
EM0906
38
Hystad Marit
EM0305
26
Jansen
Theme 2, EM0208
Hugo
Paul
46
4, 24, 25
Jessen George
EM0204
24
Kayadjanian Nathalie
EM0907
39
Keitel Susanne
EM1306
46
Kenny
Opening Plenary
20
Maureen
Kent Alistair
EM0906
38
Kesselring Gustavo
EM1305
46
Kim Ho-Jeong
EM0602
31
Kitahara
Theme 6
31
Kourliouros Sophia
Jun
EM0607
32
Kroth Elmar
EM1302
46
Kbler
EM Tutorial 3
16
Jrgen
Kureishi Amar
EM0604
Lagendijk
Theme 12, EM1206
Maarten
32
43, 44
Laslop Andrea
EM0804
35
Lastic
EM Tutorial 4
17
Pierre-Yves
Laursen Mona
EM1201
Le Cam
Yann
EM0106, EM0402
Le Gledic
Sylvie
43
23, 27
EM0205
25
Leary Liesl
EM0908
39
Lechat
Philippe
Satellite Symposium
Lery
Franois-Xavier EM1306
20
46
Leurent Pierre
EM0207
25
Leutner Dirk
EM1306
46
Lewis
David J
EM1201
43
Lewis
David JM
EM1007
40
Li Maozhong EM1002
Li
Ning
EM0202, EM0603
40
24, 31
Lightbourne Alison
EM0807
Lindstrm Gommers
EM0601
31
Lisman John
EM0103
22
Llinares Garcia
Theme 7, EM0708
Lenita
Jordi
36
4, 33, 34
Lockhart Steve
EM1001
39
Macoli arini
20
Viola
Maes Luk
EM0403
27
Maleck Klaus
EM0301
25
Malikova Marina
EM0208
25
Manolis Efthymios
EM0703
34
51

SPEAKER INDEX
Last Name
First Name
Session
Page Number
Mantua Valentina
EM0904
38
Marechal-Jamil Julie
EM1103
42
Marquet Pierre
EM0805
36
Maselbas Wojciech
EM1101
McAuslane
EM0406, EM0604
Neil
22
28, 32
Meier Alexander
EM1205
44
Menezes-Ferreira Margarida
EM0302
26
Mentzer Dirk
EM0702
Meyer
Franois
Satellite Symposium, EM0403
Michaux
Genevive
EM Tutorial 2
Mischak
Harald
EM0802, EM0805
33
20, 27
16
35, 36
Montagne Sarah
EM1208
Morris
Andrew
Opening Plenary
45
21
Moulon
Isabelle
EM0505, EM0508
30
Moult Anthony
EM0105
23
Moussa Miranda
EM0204
24
Mt-Isa Shahrul
EM1204
44
Nagano Tetsuo
EM0605
32
Nakashima Nobumasa
EM0601
31
Narayanan Gopalan
EM0306
26
Nedog Katarina
EM1208
45
Neves Judite
EM0204
24
Nielsen
Henrik Kim
Theme 6, EM0607
4, 31, 32
Niese
Detlef
Theme 8, EM0803
4, 35
Noren Niklas
EM1207
45
Norga Koenraad
EM0701
33
O'Connor Michelle
EM0202
24
Oderkirk Jill
EM0801
37
Olson Melvin
EM0501
29
Osipenko Leeza
EM0404
28
Ostler Tobias
EM0804
Ovelgnne
Hans
EM0303, EM0404
26, 27
Pani
Luca
Theme 9, EM0904
4, 37, 38
35
Parkinson John
EM0907
39
Pascual Maria
EM0303
26
Passarani Ilaria
EM0108
23
Pavlovic
Mira
Satellite Symposium
20
Pedersen
Jane Mll
EM0702
34
Pereira Doris
EM0607
32
Peuvrelle Fabien
EM0108
23
Pfister Sabine
EM0105
23
Pignatti Francesco
EM0405
28
Pilsudski
Theme 10, EM1008
Richard
Pimpaneau Valerie
EM0302
Pines Emmanuelle EM1208

Poulsen
Dorthe
Theme 1, EM0104
4, 39, 41
26
45
4, 22
Preuveneers Geert
EM1008
41
Rabinowitz Jonathan
EM0506
30
52

SPEAKER INDEX
Last Name
First Name
Session
Page Number
Rgo Lembit
EM0608
32
Raine
EM1204, EM1205
44
June
Ramsden Samuel
EM1206
Rasi
EU Town Hall Meeting, Opening Plenary
Guido
45
20, 21
Raynor Theo
EM1202
43
Reany Matthew
EM0807
36
Rees Sue
EM1201
43
Rengarajan Badri
EM0308
Retkowska-Mika
EM1103, EM1104
Lidia
27
3, 42
Rey Franoise
EM1002
40
Richardson Michael
EM1202
43
Richardson
William
EM Tutorial 5
Rodriguez
Ana
EM0101, EM0108
17
22, 23
Roediger Alexander
EM0108
23
Rohou Solange
EM0703
23
Rosenblatt Michael
EM1305
46
Rothman Brian
EM0901
37
Rueda Rodriguez
Jess
EM0205
24
Ryll
Bettina
EM0103, EM0907
Rys
Andrzej
Sadallah
Fatiha
Theme 5, EM0508
4, 29, 30
Salmikangas
Paula
Theme 3, EM0305
4, 25, 26
Salmonson
Tomas
EM0402, EM0806, EM1204
22, 39
20
27, 36, 44
Salvador-Roldn Rocio
EM0305
26
Sauer
20
Scheeren Joseph
EM0604
32
Schmiegelow Merete
EM0808
37
Schneider Christian
EM0103
22
Schoonderbeek Carla
EM1205
Schulthess
Theme 9, EM0907, EM0908
Fernand
Duane
Schultze Nathalie
EM0701
Schuring
Theme 3, EM0305
Henk
Seabroke Suzie
EM1207
Silva Lima
EM0301, EM0506, EM0805
Beatriz
44
4, 37, 39
33
4, 25
45
25, 30, 35
Simmons Valerie
EM1203
44
Singh Dinesh
EM0904
38
Sladowski Dariusz
EM0802
35
Slijkerman Diederick
EM0308
27
Sokal Etienne
EM0306
26
Speder Bruno
EM1001
Spielberg
EM0702, EM1101
Stephen
39
34, 41
Spindler Per
EM0808
Stckert Isabelle
EM0405
28
Stoffel Michel
EM1001
39
Stovall
EM0903, EM1102, EM1104
Sten
36
38, 42
Straus Sabine
EM1208
45
Stumm Matthew
EM0903
38
Sullivan Richard
EM0807
36
53

SPEAKER INDEX
Last Name
First Name
Session
Page Number
Sun Yuansheng EM1004
40
Suto Tamas
EM1305
46
Tawaragi Tomiko
EM0605
Tellner
Pr
EM0601, Theme 11, EM1102
Thalheim
Christoph
32
4, 31, 41, 42
20
Thompson Brad
EM0207
25
Thristan Mark
EM0205
Tominaga
EM0602, EM0605
Toshiyoshi
24
31, 32
Tregunno Phil
EM1207
45
Troelsen Henrik
EM0104
22
Truyen Luc
EM0706
34
Tshinanu
EM Tutorial 6
18
Tunbridge Graeme
EM0201
24
Tzalis Dimitrios
EM0504
29
Tzouma Victoria
EM0708
34
Uyama Yoshiaki
EM0602
Vamvakas
Spiros
EM0404
Van der Laan
Jan Willem
Theme 10, EM1006, EM1008
Flora
31
3, 27
39, 40, 41
Verbraska David
EM0608
32
Verstappen Daniel
EM0202
24
Vielle Cathie
EM1306
46
Vollebregt Erik
EM0207
25
Vulto Arnold
EM0807
36
Walters Margaret
EM1302
46
Wang Haixue
EM0603
31
Wang Tao
EM0603
31
Warren William
EM1004
40
Westerholm Barbro
EM0705
34
Wichems
EM Tutorial 3
16
Willan Phil
EM1202
43
Williams Tim
EM0901
43
Wirthumer-Hoche
EU Town Hall Meeting, EM0208
20,25
Christine
Christa
Wisniewski Antoni
EM1207
45
Wong-Rieger Durhane
EM0608
32
Xu
Jane (Jing)
EM0602
Zurlo
Maria Grazia
Theme 12
31
4, 43
54

NETWORKING EVENTS
Networking is an integral part of the EuroMeeting. Past attendees tell us that the networking opportunities presented by the EuroMeeting are one of the
key reasons for attending. Each year, the EuroMeeting offers numerous opportunities to catch up with existing contacts and to make new ones in a relaxing
setting. All networking events at the EuroMeeting are included in the registration fee.
EuroMeeting Bienvenue Paris Opening Reception

Monday, 13 April 2015 | 18:00-20:30 | Hall Passy Level 1
Join us at the the best-attended networking event of the conference for an excellent opportunity to renew your existing contacts and to make new ones.
The reception will take place in a unique setting. Take the exceptional opportunity to join colleagues from the EuroMeeting and Clinical Forum for an
inspirational evening of networking.
Patient Welcome Lunch

Monday, 13 april 2015 | 12:30-14:00 | Room Arlequin Level 3
Reserved for patient representatives and patient speakers only. Overview of the EuroMeeting scientific programme and an opportunity for patient
representatives to meet and network with each other prior to the conference.
Speed Networking Sessions

Monday, 13 April 2015 13:00-13:30 | Tuesday, 26 March 12:30-13:00 in the Exhibition Area 3B on Level 3
The EuroMeeting is used as a networking opportunity by all participants. However, it is not easy to walk right up to someone, introduce yourself and have a
conversation. The EuroMeeting Speed Networking session aims to make this process a lot easier.
DIA Communities Meet and Eat

Tuesday, 14 April 2015 | 13:00-14:00 Room Arlequin Level 3
An opportunity for all Community members and those interested in joining one to get together for networking at lunchtime.
Tuesday Networking Cheese & Wine Reception

Tuesday, 14 April 2015| 17:30-18:30 | Exhibition Halls Level 2 and 3
Tuesdays networking reception takes place in the Exhibition Halls on both floors. Drinks and snacks are included. It is open to all registered attendees.
Student Poster Award Ceremony

Tuesday, 14 April 2015 | 17:45-18:15
Students from around Europe will be showcasing their research in this years Student Poster Session. Posters will be located in the Bordeaux Hallway on
Level 3. In addition, join us at 17:45 in the DIA Booth 3.D17 as we present the awards for the first and second place student poster winners.
Patient Feedback Lunch

Wednesday, 15 April 2015 | 12:45-13:45 | Room Arlequin Level 3
Reserved for patient representatives and patient speakers only.
Young Professional Mentoring Lunch

Wednesday, 15 April 2015 | 12:45-13:45 | Exhibition Area 3B on Level 3
Network on the Exhibition Floors

All refreshments and lunches will be served in the Exhibition Halls, making it the ideal place to meet the people you want to meet.
CONFERENCES
& WO R KS H O P S
2015
1-2 OCT LONDON, UK I #15109

Annual joint DIA / EFGCP / EMA Better Medicines for
Children Conference
10-11 NOV LONDON, UK | #15106

9th European Medical Information and Communications
Conference
27-28 APR DAKAR, SENEGAL | #15105

4th African Regulatory Conference and Exhibition Moving towards regulatory harmonisation to enhance
access to medicines in Africa
This annual conference on Medicines for Children is

a unique opportunity to get the update of the latest
developments on the paediatric medicines and the
regulatory challenges on the area. On the conference
there will be presentations and discussions on the
Pathfinder initiative and Adaptive pathways and Clinical
Trials design/modelling and simulation in psychiatry
and neurology. The voices of patients and Health
Care Professionals and the perspectives of regulatory
authorities, industry and CROs is an essential part of this
conference.
This is a unique conference organised by medical

information professionals for medical information
professionals. The speakers share hands-on experience
of dealing with current challenges as well as successes.
It provides opportunities to showcase success stories
or stories to learn by, in the popular Putting Theory
into Practice session and to explore the impact of new
technologies on information delivery and customer
interactions. A dedicated poster session will also provide
an opportunity to broaden the topics at the conference
to other areas.
13-14 OCT LONDON, UK | #15104

(Pre-Conference on 12 OCT)
9th Annual QPPV Forum
Call for Abstracts is open and can be submitted online at

www.diahome.org/Get-Involved/Submit-Abstracts
This conference offers the opportunity for key

stakeholders active in the region to exchange progressive
views on key topics of interest and identify focus areas
for ongoing efforts aimed to increase patient access to
new and improved medicines.
18-19 MAY BASEL, SWITZERLAND | #15113
Oncology Drug-induced Cardiotoxicity Conference
From bench to bedside
As survival rates in oncology patients further increase,
early detection and early development of diagnostic and
mitigation strategies are needed to facilitate optimal
outcomes in the treatment of oncology patients.
24-25 JUN DAR ES SALAAM, TANZANIA | #15107
4th Global Animal Health Conference
Regulatory Convergence
The International Federation for Animal Health (IFAH) is
organising the 4th in the series of Global Animal Health
Conferences with the support of an Organising Committee
and funded by the Bill and Melinda Gates Foundation.
Leading figures from government, academia, industry,
and international organisations will share over 1.5 days
challenges and solutions for improving regulatory
convergence for veterinary product registration. The
focus will be on developing countries and on how to
enable the widest availability of high quality, safe and
efficacious products in these markets, with an emphasis
on Africa, and East Africa in particular.
30 JUN BRUSSELS, BELGIUM | #15117
DIA/TOPRA Workshop on Adaptive Pathways
Adjusting the route to the market is vital to support
innovation and timely approvals for products that could
cover unmet or high medical needs. The workshop
aims to look into both the regulatory hurdles as well
as discuss improvements in market access based on
evidence from recent years and the situation in European
countries. Insights from experts from both regulatory
as well as market access (HTA) side are brought to the
table, connecting all stakeholders. The outcomes will be
compiled into white paper.
22 SEP VIENNA, AUSTRIA | #15118
The New Medical Device Regulation Information Day
You will get an overview of the EU device legislative
system updates. This Information Day provides an insight
of the essential changes in various fields, such as the role
of notified bodies and all requirements in clinical or postmarket requirements.
This is the only forum designed for QPPVs by QPPVs,

now in its 9th year and ever growing. Over time, one
of the key successes of the Forum has been the ability
to secure continuing support and involvement of key
regulators. Sessions have been open and interactive with
attendees appreciating opportunities to raise challenging
issues in an informal environment. This 9th QPPV Forum
aims to continue to attract such key speakers and
encourage open debate.
26-27 OCT LONDON, UK I #15111
Clinical Trials Workshop
The new EU Clinical Trials Regulation is expected to
become applicable in 2016. The new legislation will have
implications on clinical trial sponsors preparing and
submitting clinical trial applications. Member States will
have to adapt their procedures and the new Regulation
will impact how the conduct of a clinical trial is managed
after approval has been granted. New provisions for
public access to an EU Clinical Trials Database will enforce
disclosure of clinical trials data and information.
This 2-day workshop will provide a forum for information
exchange and discussion on conceptual and practical
questions through lectures and panel discussions.
4-5 NOV LONDON, UK | #15115
Biosimilars Conference European view on biosimilars
with a global outlook
This 2-day conference is the third of its kind. It will
provide an update on the current status for biosimilars
in EU and internationally with focus on both regulatory
and scientific challenges as well as market access and
experiences. Patients and physicians approach to use of
biosimilars will be part of the conference scope including
a discussion on biosimilars adoption into current
treatment guidelines in EU. The conference will consist of
plenary lectures followed by interactive panel discussions
providing participants an opportunity
NOVEMBER/DECEMBER I #15110
16th Conference on Electronic Document Management
Join to find out about the latest trends in document
management, content and information management,
electronic submissions and a lot more.
This conference is currently in development and more
information will be available shortly.
17-18 NOV MIDDLE EAST LOCATION I #15102

11th Middle East Regulatory Conference (MERC)
This is the 11th DIA Middle East Regulatory Conference
(MERC) in partnership with the Middle East Regulatory
Network (MERN). This Conference marks an important
milestone it will celebrate the 20 year anniversary of
MERC and will reflect on the significant progress made
over that period. It provides a forum for all participants
to contribute to active discussion and identify actions to
expedite access of valued innovative medicines to Middle
Eastern patients. This years conference will explore
advances in regulatory science and discuss the benefits
of regulator collaboration & convergence. It will ask how
this can be put into practice to meet the challenges of
assessing innovative medicines.
2016
6-8 APR HAMBURG, GERMANY | #16101
28th Annual EuroMeeting
Solutions are found through exchange of knowledge
between professionals involved in therapeutic innovation
and regulatory science. Attend the DIA EuroMeeting 2016
and join us in advancing the future of world health!
DIAs European flagship conference is the place to meet
and learn what will be hot in 2016. Choose from 12
themes, 100 sessions and tutorials, and visit one of the
largest exhibition halls in Europe, where you will find
innovation on every corner, and benefit from countless
opportunities to network with thought leaders from
industry, academia, and regulatory agencies.
26-28 MAY EDINBURGH, UK I #16106
8th European Conference on Rare Disease & Orphan
Products (ECRD 2016) Game changers in rare
diseases
This biennial conference is the unique forum across all rare
diseases, across all European countries, bringing together
all stakeholders.
ECRD covers research, development of new treatments,
healthcare, social care, information, public health and
support at European, national and regional levels.
ECRD provides the state of the art of the rare disease
environment, monitoring and benchmarking initiatives.


09:00-12:30 Pre-conference Tutorials
11:00-12:30 HAS Satellite Session | 13:30-15:00 Regulatory Town Hall Meeting | 15:00-16:00 Refreshment Break in the Exhibition Halls | 16:00-17:45 Plenary Session
18:00-20:30 EuroMeeting Welcome to Paris Opening Reception on Level 1
Theme 1
Theme 2
Theme 3
Theme 4
Access to Innovative Treatments
Medical Devices and


Early Dialogue with

Regulators and HTA Bodies
on Innovative Medicines
Session 0101
The Role of the New Clinical
Trial Legislation
Session 0201
New Medical Device
Regulations in the EU
Session 0301
Approval Process and Experience
to Date/Challenges and Successful
Outcomes of ATMP Development
Blue Room Level 2
Room 241 Level 2
Room 251 Level 2
Session 0202
Impact of the Regulations in Practice
across Regions
Session 0302
Quality Aspects for an ATMP
(m3 of MAA)
Session 0402
Regulatory Evidence Standards: Are
we maximising value generation?
Room 241 Level 2
Room 242 Level 2
Room Havane Level 3
Session 0103
Clearing the Path for Innovations
in Drug Development
Session 0303
Adaptive Licensing for ATMPs
Session 0403
Shaping European Early Dialogues:
The SEED project
Blue Room Level 2
Room 243 Level 2
Room Havane Level 3

Session 1
09:00-10:30
Session 2
11:00-12:30
Session 3
14:00-15:30
Session 4
16:00-17:30
Session 0104
Primary Factors for Trial Location
Session 0204
Impact of the Regulations on SubstanceBased Medical Devices
Session 0404
Lifecycle of Regulatory/HTA Advice
Blue Room Level 2
Room 241 Level 2
Room Havane Level 3
Session 5
09:00-10:30
Session 6
11:00-12:30
Session 7
14:00-15:30
Session 8
16:00-17:30
Theme 1
Theme 2
Theme 3
Theme 4
Access to Innovative Treatments
Medical Devices and


Early Dialogue with

Regulators and HTA Bodies
on Innovative Medicines
Session 0105
Impact of The Clinical Trial Regulation
on CMC Filing and Relevant GMP
Requirements
Session 0205
New IVD Regulations in the EU
Session 0305
ATMP Regulations - ongoing review
Session 0405
Patient Involvement in the
Development Dialogue with
Regulatory Authorities and HTAs
Room 251 Level 2
Room 242 Level 2
Room 253 Level 2
Room Bordeaux Level 3
Session 0106
MAPPs- Holding hands across
the lifecycle
Session 0306
Moving from Risk Management to
Benefit/Risk Management Planning
Session 0406
One-Step Approach in Pricing, HTA
Appraisal and Reimbursement
Blue Room Level 2
Room 253 Level 2
Room Havane Level 3
Session 0107
MAPPS: Fostering Collaborative Models
for Clinical Development
Session 0207
Health Apps: Definition, regulation & use
Session 0407
HTA and Adaptive Pathways
Blue Room Level 2
Room 242 Level 2
Room Havane Level 3
Session 0108
Disclosure of information
Session 0208
Clinical, Quality & Registration
Considerations for Biologics
Combination Products Development
Session 0308
Challenges for Development
of Rare Diseases
Blue Room Level 2
Room 242 Level 2
Room 253 Level 2


Theme 5
Theme 6
Theme 7
Theme 8
Collaborative Consortia, IMI and the

Way to Horizon 2020
Implementing Innovation Globally

Conducive Regulatory Policiess

Pregnancy

Regulatory Science
Session 0501
Strengthening Collaborative Innovation and
Maximising Mutual Benefit
Session 0601
ICH, IPRF, ICMRA: How are these initiatives
advancing regulatory harmonisation and
convergence?
Session 0701
What Will the Future Bring Innovative
Paediatric Development
Room Havane Level 3
Room Maillot Level 2
Room 252 Level 2
Session 0602
Asia: Creating possibilities for clinical
development and collaboration
Session 0702
How Will the Global Needs of Paediatric
Development be Addressed?
Session 0802
The Role of Translational Medicine in the
Future of Life Science
Room 252 Level 2
Room 251 Level 2
Session 0503
Minimising Costs, Hurdles, and Duplication
Session 0603
China Regulatoy Session:
Updates from the CFDA
Session 0703
Modelling and Simulation in Paediatrics: The
next Step- keeping the momentum
Session 0803
Is the Classification of Disease on Par with
Therapeutic Innovation?
Room 241 Level 2
Room 252 Level 2
Room 251 Level 2
Session 0504
In Between: SMEs Perspective on PPPs
Session 0604
China: Opportunities and challenges for
innovation
Session 0804
The Risk-Based Approach for New Medicines
Development: From ATMPs to "conventional"
drugs
Room 252 Level 2
Room 251 Level 2

Theme 11
Theme 6
Theme 7
Theme 8
Collaborative Consortia, IMI and the

Way to Horizon 2020
Implementing Innovation Globally

Conducive Regulatory Policiess

Pregnancy

Regulatory Science
Session 0505
Developing Best Practice Guidance on Patient
Engagement in Medicines R&D
Session 0605
PMDA Updates: Discussion of latest plans and
new directions in regulation Town Hall
Session 0705
The Silver Generation- how does development
address their needs?
Session 0805
Diagnostic and Pharmacodynamic Biomarkers
and Mass Spectrometry Assays Thereof:
Current status and perspectives
Room 241 Level 2
Room 252 Level 2
Room 243 Level 2
Session 0506
Collaborative Innovation in Biomedicine
Serving Industry, Academy and Society
Session 0706
How to Overcome Challenges in the
Development of Medicines to Treat Dementia
Session 0806
Classification of Medicinal Products factors affecting regulators decisions, is
harmonisation possible and necessary?
Room 243 Level 2
Room 252 Level 2
Room 251 Level 2
Session 0507
A Participatory Society for Better Health
Session 0607
From the Shop Floor: Practical advice on
bringing new medicines to patientss
Session 0807
Translating Regulatory Approval into
Healthcare Uptake: The next challenge for
biosimilars
Room 253 Level 2
Room 251 Level 2
Session 0508
Panel Discussion with Public-Private
Partnership Stakeholders
Session 0608
Emerging Markets Update: What on Earth is
going on with regulator convergence?
Session 0708
50 Years after Thalidomide
developing drugs in pregnancy
Session 0808
Regulatory Science- new parnerships
Room Havane Level 3
Room 252 Level 2
Room 251 Level 2


Theme 9
Theme 10
Theme 11
Theme 12
Theme 13
Innovation in Vaccines
Development
Availability of Medicinal
Products
Pharmacovigilance in 2015
- Poised for convergence of
innovation
Hot Topics/Stand Alone

Sessions
Session 1001

Session 0901
eHealth: Putting information to work
Adaptive Pathways and Patient Access

Models to Innovative Treatments: Is it
applicable to the development of vaccines?
Session 1101
Some Basics about Shortages of
Medicinal Products: Concepts, causes,
situation and trend
Session 1201
Pharmacovigilance Debate: Brave
new
world of decision support
Room 242 Level 2
Room 243 Level 2
Room 253 Level 2
Session 1002
Vaccine Development across
Regions
Session 1102
Shortages Consequences: Their
impact in patients, health care
professional and regulators
Session 1202
Pharmacovigilance: How well are
patients informed and how can they
contribute?
Session 1302
Essential Business Change
Management in Pharmacovigilance
Room 243 Level 2
Room 253 Level 2
Blue Room Level 2
Session 0903
Going Mobile: Disruptive technology
at your fingertips
Session 1103
Solving and Preventing Shortages/
Communication between Different
Stakeholders
Session 1203
International Collaborations in
Pharmacovigilance: Common
objectives, common challenges
Room 242 Level 2
Room 253 Level 2
Session 0904
Big Data: Moving beyond buzz
words to results
Session 1004
New Avenue for Non-Clinical
Regulatory Science
Session 1104
Looking at the Future of Shortages
of Medicinal Products
Session 1204
Benefit/Risk- pragmatic
lifecycle management
Room 242 Level 2
Room 243 Level 2
Room 352B Level 3

Theme 9
Theme 10
Theme 12
Theme 13
Innovation in Vaccines
Development
Pharmacovigilance in 2015
- Poised for convergence of
innovation
Hot Topics/Stand Alone

Sessions
Session 1205
Is it Off-Label Use or
Medication Error?
Session 1305
Pharma Medical Affairs:
Vision though 2020
Blue Room Level 2
Room Havane Level 3
Session 0906
Social Media, Patients and Public
Policy
Session 1006
Adjuvants in Vaccines
Session 1206
Managing the Risk or
Managing the Plan?
Session 1306
50 Years of EDQM
Room 241 Level 2
Room 242 Level 2
Session 0907
Who Owns My Health Data?
Session 1007
BIOVACSAFE (IMI Project)
Session 1207
Signal Detection and Management:
Can you whistle?
Room 241 Level 2
Room 243 Level 2
Session 0908
Real-World Evidence for Medicines
Adaptive Pathways to Patients
(MAPPS)
Session 1008
New Developments, Ebola Vaccines
Session 1208
PRAC: Highlights, challenges
and Referrals
Room 241 Level 2
Room 243 Level 2
2015
Chemistry, Manufacturing and Controls
Quality by Design - New concepts for

chemical and biotech product development
and optimisation
Participants from pharmaceutical, biotech and generic
industry as well as regulators will learn how to use QRM,
Process Characterisation, DoE, Development of a Design
Space and Control Strategy, as well as the tools of Knowledge
Management (KM).
Clinical Research
18-20 MAY LONDON, UK| #15557
Essentials of Clinical Study Management

After successful completion of the training course, participants will be able to plan, execute and manage a clinical study
from protocol to final report.
16-18 SEP LONDON, UK | #15542
Clinical Project Management Part I

This course provides a comprehensive foundation in clinical
project management. Using the Project Management Body of
Knowledge (PMBOK) as a guide, participants will be taught
how to apply project management strategies, tools and
techniques to their clinical trial projects.
16-18 NOV LONDON, UK | #15555
Clinical Project Management Part II

This is the second part of the 2-part course on Clinical Project
Management, concentrating on specific concepts such as
project quality risk management.
14-16 OCT LONDON, UK | #15531
Practical GCP Compliance Auditing of Trials

and Systems
This course provides practical training for industry auditors
and regulatory authority inspectors, who are faced with the
task of auditing clinical trials and related systems. It will also
be of interest to those with managerial responsibilities.
15-16 OCT LONDON, UK | #15532
Clinical Statistics for Non-Statisticians

This course is an introduction of basic statistical concepts
fundamental to clinical research, for professionals who have
regular exposure to statistics.
Regulatory Affairs
4-5 NOV PARIS, FRANCE | #15556
Essentials of European Regulatory Affairs

This is the must-attend training course for anyone needing to
learn the essentials of European Regulatory Affairs.
16-18 NOV LONDON, UK | #15554
US Regulatory Affairs: A comprehensive

review of regulatory procedures for INDs and
NDAs in the US
This course is designed for persons with a background in
pre-clinical research, clinical research, quality assurance
or academia, who need knowledge of the US regulatory
processes.
9-10 NOV DUBAI, UNITED ARAB EMIRATES | #15562
Building the eCTD - Practical Approaches to

compiling Electronic Submissions
Participants will learn about the Electronic Common Technical

Document (eCTD), its components and history, preparing
submission ready documents, and how to change your business processes in preparation for moving towards electronic
submissions.
6-7 MAY AMSTERDAM, THE NETHERLANDS | #15551
HTA for Non-HTA user
A foundation course designed especially for non-HTA experts

interested in gaining a better insight into the role of HTA in
decision making processes in the health care sector.
TRAINING
COURSES
17-18 SEP LONDON, UK | #15552
26 APR DAKAR, SENEGAL | #15559
This course will provide a full introduction to PIPs and the EU

Paediatric Regulation.
Participants will gain solid knowledge and a clear

understanding of international approaches to drug safety
pharmacovigilance, as well as the best practices for successful
local and global regulatory applications.
Paediatric Investigation Plans (PIP)
ICH Endorsed Pharmacovigilance
Medical Devices: Regulation and lifecycle

management
18-19 MAY LONDON, UK | #15539
All you need to know about medical devices, if you are

not working with devices on a daily basis or your need an
overview.
14-15 OCT LONDON, UK | #15546
How to Prepare for your Meeting with Health

Authorities
This course covers Health Authority (HA) meetings and other
interactions in the EU and the US. You will learn by performing
role plays yourself and by many case studies.
25-27 NOV VIENNA, AUSTRIA | #15545
Biopharmaceuticals, Biosimilars and Advanced

Therapies in Europe - Development and
Regulatory Framework in Europe
Participants will learn about the legislative and regulatory
framework for biopharmaceuticals in Europe and the roles
of the European Medicines Agency and National Competent
Authorities in market access.
Comprehensive Training on European

Regulatory Affairs including Different
Registration Procedures and Variations: Expert
Overview
This is a complete comprehensive in-depth training on
European regulatory affairs, exploring all aspects of medicinal
product lifecycle management.
NEXT OCCURANCE TO BE ANNOUNCED
10-11 JUN PARIS, FRANCE | #15540
Medical Approach in Diagnosis and

Management of ADRs
Combo
Pricing*
How to use medical knowledge in the diagnosis and

management of selected Adverse Drug Reactions (ADRs).
11-12 JUN PARIS, FRANCE | #15544
Diagnosis and Management of Drug-Induced

Liver Injury (DILI)
This course will provide tools, explanations, examples and
several exercises for a better understanding of DILI and how
best to apply that knowledge in day to day work.
Post-Authorisation Safety Studies (PASS)

This course delivers insight in (pharmaco-)epidemiological
methodology for non-interventional studies, and the concept
of multi-departmental collaboration for the development and
conduct of a PASS.
YEAR-ROUND
EMA HEADQUARTERS, LONDON
AND SELECTED EUROPEAN CITIES
EudraVigilance Courses and EMA

Information Days
Approval of Generic Medicines in the

EU. Focus on CMC requirements and
bioequivalence
The overall requirements for the approval of generics will be
detailed including problems in relation to generic substitution
and falsified medicines.
Safety and Pharmacovigilance

How to Prepare for Pharmacovigilance
Audits and Inspections
Participants will be guided through all the regulations

and guidelines pertinent to pre-marketing safety in the
EU. The course offers an overview of all the current major
methodological approaches and hands-on solutions for dayto-day challenges.
21-22 SEP BERLIN, GERMANY | #15535
28-29 APR BASEL, SWITZERLAND | #15550
Pre-Marketing Clinical Safety
EudraVigilance Electronic Reporting of

ICSRs in the EEA
eXtended EudraVigilance Medicinal Product
Dictionary
28 APR LONDON, UK | #15522
Combo
Pricing*
The course will teach you how to prepare for an inspection

from the announcement (or of the arrival of the inspectors at
your doorstep) to the conclusion.
27-28 APR BASEL, SWITZERLAND | #15534

Signal Management in Pharmacovigilance

The course will teach basic concepts of signal detection
and signal management and how to apply them within the
participants functions.
Benefit/Risk Management
This intensive course explores current opportunities made

possible by the new legislation, advances in information
technology and a new scientific methodology to enhance
and modernise the approaches in the product lifecycle
management.
Information Day on New Services and

Systems in Pharmacovigilance: Preparing
for Business Change
29 APR LONDON, UK | #15521
ICSR Information Day
1 JUN LONDON, UK | #15523
Risk Management Plan Information Day

Information Day on Post-Authorisation

Studies (PAS)
ISO IDMP Information Day
SAVE TIME AND TRAVEL COSTS with

IN-HOUSE TRAINING
Excellence in Pharmacovigilance: Clinical trials

and post-marketing
All DIA Training Courses can be held on your

premises and tailored to your needs.
By attending this course you will gain a firm grounding in key

aspects of safety and pharmacovigilance from a European
and global standpoint.
Get the best value and train your whole team!
Discover new opportunities at diahome.org. Call DIA offices at +41 61 225 51 51 or diaeurope@diaeurope.org
6-8
April 2016
28 Annual
EuroMeeting
th
CCH Congress Center Hamburg

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27th Annual EuroMeeting

Development, Innovation, Access and Patient Safety

13-15 April 2015

DIA EuroMeeting 2015

Welcome Form DIA Chair, DIA Board of Directors and

It is our pleasure to welcome you to Paris, the hub of European biotech

Welcome from the EuroMeeting 2015 Co-Chairs

Theme 3 | Advanced Therapies, Novel Treatments

On behalf of the DIA Board of Directors and all of our EuroMeeting

Theme 8 | Translational Medicine and Regulatory Science............... 35-37

Theme 4 | Early Dialogue with Regulators and

Theme 9 | Big Data, Mobile Health........................................................... 37-39

Enjoy the programme!

Theme 11 | Availability of Medicinal Products: Drug shortages.........41-42

Barbara Lopez Kunz

DIA EuroMeeting 2015

WELCOME FROM THE EUROMEETING 2015 CO-CHAIRS

Lidia Retkowska-Mika and Olivier Charmeil

DIA EuroMeeting 2015

EUROMEETING 2015 THEME LEADERS

Susanna Del Signore

Beln Escribano Romero

Sabina Hoekstra-van den Bosch

Jordi Llinares Garcia

Henrik Kim Nielsen

Jan Willem van der Laan

Maria Grazia Zurlo

DIA EuroMeeting 2015

Sunday, 12 April 2015

DIA Communities - Meet and Eat

Parallel Scientific Sessions - Session 3

Exhibitor Registration and Set-up

Choose from Parallel Sessions

Attendee and Speaker Registration*

Exhibition Guest Passes

Students and Young Professionals Welcome

Coffee Break in the Exhibition Hall

Parallel Scientific Sessions - Session 4

Choose from Parallel Sessions

* Avoid the rush on Monday by picking up your badge and conference

Networking Reception in the Exhibition Hall

material on Sunday afternoon

Student Poster Award Ceremony at the DIA Booth

Monday, 13 April 2015

Wednesday, 15 April 2015

Exhibitor Registration and Set-up

Attendee, Speaker and Exhibitor Registration

Attendee, Speaker and Exhibitor Registration

Exhibition Hall Open

Pre-Conference Tutorials Coffee Break

Parallel Scientific Sessions - Session 5

HAS Satellite Symposium

Choose from Parallel Sessions

Conference and Exhibition Open

Coffee Break in the Exhibition Hall

Lunch & Innovation Theatre Presentation in the

Parallel Scientific Sessions - Session 6

Choose from Parallel Sessions

Regulatory Town Hall Meeting

50 Years of EDQM Session

Optional Clinical Forum Tutorials*

Lunch & Innovation Theatre Presentation in the

Extended Refreshment Break in the Exhibition Hall