Vaccinology Masters Programme Brochure Final

Siena, Italy
May 2009 - April 2011
Masters Programme in Vaccinology &

Pharmaceutical Clinical Development
2-year programme jointly sponsored by the University of Siena,
Medical School and Novartis Vaccines & Diagnostics, Siena.
The Masters programme is innovative

- It teaches specific skills
- It is thorough and exhaustive
- It provides extensive practical training
- It prepares the student for a career in academia, public health or in
vaccine clinical development, within the pharmaceutical industry
Participants will receive a 2-year grant

Masters in Vaccinology &
SPONSORS, MODULE DIRECTORS, FACULTY and GUEST SPEAKERS
This Masters Programme in Vaccinology and Pharmaceutical Clinical Development is sponsored by

Dr. Rino Rappuoli (Head Global Research, Novartis Vaccines and Diagnostics), Dr. Ralf Clemens (Head
Global Development, Novartis Vaccines and Diagnostics) and Dr. Allan Saul (Chief Executive Officer,
Novartis Vaccines Institute for Global Health).
Drs. Rappuoli, Clemens and Saul will also be part of the Faculty and will give lectures during the Masters.
Several heads of global departments within Novartis Vaccines & Diagnostics (NVD) and the Novartis
Vaccines Institute for Global Health (NVGH) are assigned as the Module Directors and will be respon-
sible for the content and design of each module and for the liaison with the University of Siena.
Additionally, many scientists from the international Novartis Vaccines staff and from the University of
Siena will be invited to be part of the Faculty and to contribute to the teaching program in their area
of expertise. Among them: Prof. Heinz-Josef Schmitt (Medical Affairs), Dr. John Ferguson (Pharmaco-
vigilance), Dr. Theodore Tsai (Scientific Affairs), Dr. Klaus Stöhr (Influenza), Dr. Peter Dull (Meningitis),
Dr. Uwe Nicolay (Biostatistics), Dr. Luiz Jacintho Da Silva (Epidemiology) and others.
Keystone lectures will be delivered by a selection of eminent guest speakers, with international repu-
tation in vaccine development. The following have already agreed to participate: Prof. Robert Steffen
(University of Zurich, Switzerland), Prof. Frank von Sonnenburg (University of Munich, Germany),
Prof. Paul-Henry Lambert (University of Geneva, Switzerland), Dr. Roland Dobbelaer (former chair
of the EMEA Vaccine Working Party, Belgium), Dr Manfred Haase (former member of EMEA CHMP
and Director of the Paul-Erlich-Institute, Germany), Prof. Joel Ward (UCLA, U.S.A.), Prof. Pietro Crovari
(University of Genova, Italy), Prof. Roberto Gasparini (University of Genova, Italy), Prof. Susanna
Esposito (University of Milan, Italy), Prof. Paolo Bonanni (University of Florence, Italy), Prof. Giovanni
Gabutti (University of Ferrara, Italy), Dr. Anne-Marie Georges (AMQuidPharma, Belgium), Prof. Karl
Nicholson (University of Leicester, U.K.), Prof. Juhani Eskola (National Public Health Institute (KTL),
Finland), Prof. Fred Zepp (University of Mainz, Germany), Prof. Donato Greco (Istituto Superiore di
Sanità, Italy) and Dr. Daniel Brasseur (Chair of the EMEA Pediatric Committee, Belgium).
Coordinator & President Technical-Scientific Committee:.

Prof. Ranuccio Nuti (University of Siena)
TECHNICAL-Scientific Committee:
Prof. Gianni Rossolini (University of Siena),
Dr. Audino Podda and Dr. Giovanni Della Cioppa (Novartis Vaccines & .Diagnostics)
Organisation:
Benedetta Caselli (Human Resources, Novartis Vaccines & Diagnostics)
LOCATION & DURATION

Novartis Vaccines & Diagnostics, Siena, Italy
May 2009 – April 2011 (full-time)
ORGANISED BY
Novartis Vaccines & Diagnostics (NVD) & University of Siena, Italy

http://www.novartisvaccines.com http://www.unisi.it/internet/home.html
CONTENTS
SPONSORS, MODULE DIRECTORS, FACULTY and GUEST SPEAKERS
WHY IS THE MASTERS PROGRAMME IN VACCINOLOGY & PHARMACEUTICAL

CLINICAL DEVELOPMENT INNOVATIVE?.........................................................................................................................................2
Minimum entry requirements....................................................................................................................................................3
Funding.......................................................................................................................................................................................................3
Application and selection procedure................................................................................................................................3
Overview of modules and credits.........................................................................................................................................4
Academic calendar ..........................................................................................................................................................................4
Details per module............................................................................................................................................................................5
VACCINE DEVELOPMENT process ..........................................................................................................................................5
Vaccine preventable diseases & vaccinology ......................................................................................................5
Immunology & translational medicine.......................................................................................................................6
Vaccine Development Process...........................................................................................................................................7
Clinical development methodology & PHARMACOVIGILANCE.........................................................................8
Regulatory affairs.....................................................................................................................................................................9
Good clinical practice & clinical quality assurance..................................................................................10
CLINICAL TRIAL OPERATIONS....................................................................................................................................................11
Biostatistics & clinical data management............................................................................................................12
Policies and recommendations for vaccines in the world.....................................................................13
General information for students...................................................................................................................................14
Application to University of Siena......................................................................................................................................15

page 2 | Masters in Vaccinology & Pharmaceutical Clinical Development
First references to the university of Siena date back to 1240, making it one of the most
ancient academic institutions in Europe. In 1357 Emperor Charles IV, in a document
issued in Prague, included Siena among the official universities of the Holy Roman
Empire. Today, the University of Siena runs a wide selection of graduate and postgraduate
courses, including doctoral degree programmes, specialization schools and masters
programmes.
Why is the Masters Programme in Vaccinology &

Pharmaceutical Clinical Development innovative?
Provides graduates in Medicine with training on all aspects of developing
vaccines, from basic research to health authority approval and beyond.
Collaboration between academia and industry
Classroom sessions with a team of scientists and researchers with years of
experience in basic research, technical and clinical research & development of
vaccines
Topics include all R&D aspects, such as immunology and infectious diseases,
clinical research methodology and epidemiology, biostatistics and clinical data
management, regulatory aspects and the production of vaccines
Students will participate in real life clinical and regulatory activities within the
company and be intensively involved in development programs
The Masters programme is in English and provides two options:
- a complete two-year course, the first year including lectures and on-the-job
training, the second year consisting of an internship within one or more of
the clinical or regulatory teams. The second year will be completed with a
dissertation leading to an M.Sc. degree from the University of Siena, Italy.
- a one-year course, as the first year above, with a training certificate from
Novartis Vaccines & Diagnostics.
Masters in Vaccinology & Pharmaceutical Clinical Development | page 3
MINIMUM ENTRY REQUIREMENTS

- University degree in Medicine
- Excellent command of English, written and spoken
FUNDING
A 2-year grant will be provided to students who are accepted.
APPLICATION AND SELECTION PROCEDURE

To apply for this Masters in Vaccinology and Pharmaceutical Clinical
Development, please send your curriculum vitae* and a letter of motivation,
in English, to: vaccines_master.nvdit@novartis.com
Before 15 December 2008
* Please make sure that your curriculum vitae contains details of your
command of the English language, specifying courses attended (including
those in Medical School) and the level reached by examination.
Students will need to make a formal application to the University of Siena,

before 27 February 2009 (see page 15 of this brochure). Assistance will be
provided by Novartis Vaccines & Diagnostics, where necessary (e.g. for non-
Italian candidates).
Contact person:
Mrs. Hilary Franklin

Global Clinical Research & Development department
Novartis Vaccines & Diagnostics S.r.l.
Via Fiorentina 1, Siena, Italy
Tel: +39 0577 24 3525 or +39 335 750 2395
OVERVIEW OF MODULES AND CREDITS
F I RST Y ear credits key

module
1. Vaccine development process 1
2. Vaccine preventable diseases & Vaccinology 5
3. Immunology & Translational Medicine 4
4. Technical Operations & Quality 3
5. Clinical Development methodology & Pharmacovigilance 5
6. Regulatory Affairs 3
7. Good Clinical Practice & Clinical Quality Assurance 2
8. Clinical Trial Operations 5
9. Biostatistics & Clinical Data Management 4
10. Policies and recommendations for vaccines in the world 3
35
11. Internship 25
60
Second Y ear
12. Internship & thesis 60
ACADEMIC CALENDAR
DETAILS PER MODULE
VACCINE DEVELOPMENT PROCESS

Module: 1 Credits: 1 Semester: 1
Duration: 25 hours, distributed over 1 week.
Module Director: Emanuela Palla, Head Early Development Projects, NVD
Aim: Students will understand the overall principles and key steps of pharmaceutical clinical
development process, from bench to patient.
Content:
Key steps in the development process
Decision making on project progress
The role of cross-functional teams
Role and tools in project management
Short introduction to each of the modules 2-10
Method of working: Lectures (16 hours), self-study & test (9 hours)
Evaluation: End of module: Written test
End of year: Written and oral examination
Vaccine Preventable Diseases & VACCINOLOGY

Duration: 125 hours, distributed over 4 weeks
Module Directors: Emanuela Palla, Head Early Development Projects, NVD
Audino Podda, Head Clinical Development, Novartis Vaccines Institute for Global
Health (NVGH)
Aim: Students will have an overview of vaccine-preventable diseases and gain insight into the basic
principles of vaccinology.
Content:
Vaccine preventable diseases
Vaccinology
- Historical background
- Current vaccinology practice & schedules
Types of vaccines
Overview of currently available vaccines
New vaccines under development
Method of working: Lectures (40 hours), self-study, written assignments, tests, etc. (85 hours)
Recommended 1. “New Generation Vaccines - third edition” edited by M.M. Levine, J.B. Kaper, R.
Reading: Rappuoli, M.Liu, M.F. Good - published by Marcel Dekker
2. “Vaccines- fourth edition” edited by Plotkin & Orenstein - published by Saunders
Evaluation: During module: Written assignments, student seminars on selected topical
scientific papers
End of module: Written test
Immunology & Translational Medicine

Module Director: Giuseppe Del Giudice, Global Head Translational Medicine, NVD
Aim: Students will understand the basic concepts of immunology, in particular the immune
responses to vaccines, and how to translate these facts into vaccine production and licensing.
Content:
Identification of vaccine targets

- Antigen structures as potential vaccine candidates
- Conventional and novel approaches to vaccine development
Serology
- Antibody response and correlates of protection
- Functional assays versus quantitative assays
Basis of the immune response

- B-cell responses and antibody production - T-cell responses (induction, differentiation, memory
and ways to measure their functions)
- The immunological basis of adjuvant function (innate immunity, Toll-like receptors, ways to
investigate adjuvant function)
Pre-clinical evaluation of vaccine safety
The analysis of immune responses to vaccines in clinical trials

- The why’s, the how’s and the constraints
- How to translate these findings into vaccine licensing (validation and regulatory hurdles)
Method of working: Lectures (32 hours), self-study, practical and written assignments, tests etc.
(68 hours)
Evaluation: During module: Written assignments
End of module: Written tests
End of year: Written and oral examination.
Vaccine Development Process

Module Director: Vittoria Pellegrini, Head Technical and Business Affairs, Siena, NVD
Aim: Students will understand the concepts, methods and challenges of technical operations and
quality of vaccine manufacturing.
Content:
History of vaccine production, challenges & advances

Production processes in bacterial and viral vaccines
- Working seed-bulk-formulation-filling-packaging
- Products in development
- Industrialisation (scale-up)
- From idea to product
Organisation
- Procedures and flows in manufacturing and control vaccines
- Plant structure & layout, shifts
Quality - throughout the process - the importance of Good Manufacturing Practices (GMP)
to guarantee an immunogenic and safe product
- Selection of raw materials
- Systems as tools to monitor and control
Labelling & packaging
Differences between vaccine and pharmaceutical production
Method of working: Lectures (24 hours), self-study, visits to manufacturing facilities, practical and
written assignments, tests etc. (51 hours)
Evaluation: End of module: Written examination
Clinical Development MethodologY & PHARMACOVIGILANCE

This module will be provided simultaneously with module 6 ‘Regulatory Affairs’.
Module Directors: Giovanni Della Cioppa, Head Global Clinical Research & Development, NVD.
Audino Podda, Head Clinical Development, Novartis Vaccines Institute for
Global Health (NVGH).
Aim: Students will understand the basic principles of clinical development in the pharmaceutical
industry and of clinical trial methodology, in particular in the area of vaccine development.
Content:
Overview of the clinical development process
- Clinical development plans
- Phases of the clinical development process: Phase I - II - III - IV trials
- Experimental studies (clinical trials) vs. epidemiology (observational) studies
- Safety, immunogenicity, efficacy
- Life-cycle management of a product
- Geographical, logistical & economical considerations
Clinical trial methodology and protocol development
- Why clinical trials? Variability of biological phenomena and measurement errors
- Defining the treatment effect
- The choice of the sample: which subjects, how many subjects
- The choice of treatments: study treatments, concomitant treatments
- Experimental designs
- The protocol approval processes: internal, external, amendments
Ethical considerations in clinical development
Health economics considerations in clinical development
Clinical study reports
- Content
- Report writing principles
- Quality control and approval processes: internal, external
Safety reporting and pharmacovigilance
- Risk-benefit assessments
- Adverse Events (AEs), Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse
Reactions (SUSARs)
- Expedited reporting, annual safety reports to regulatory authorities.
Pitfalls & challenges in clinical development
- Cost-benefit, logistical issues, patents, competition, supply problems, seasonal vaccines, etc.
Recommended Reading: “Fundamentals on clinical research. Bridging medicine, statistics and
operations” by Antonella Bacchieri & Giovanni Della Cioppa
Publisher: Springer-Verlag, 2007
Method of working: Lectures (40 hours), self-study, practical assignments in Clinical
Development teams, business training, tests etc. (85 hours)
Regulatory Affairs
Duration: 75 hours, distributed over 4 weeks, simultaneously with module 5 ‘Clinical
Development & Methodology’
Module Directors: Edward Thomas Reilly, Head Regulatory Affairs for Europe & International, NVD
Hillel Cohen, Head Regulatory Affairs for the Americas
& Head Regulatory Affairs for Early Development, NVD
Aim: Students will understand the international regulatory environment and detailed requirements
related to obtaining approval for marketing vaccines and the maintenance of these licences.
Content:
Introduction
- General overview of main Competent Authorities (FDA, EMEA, MHLW)
- International Conference on Harmonisation (ICH)
Drug development life cycle from a regulatory perspective

- Preclinical
- Phase I – initial safety
- Phase II – proof of concept, dose ranging
- Phase III – efficacy, large scale safety
- Post Approval Commitments – clinical studies, epidemiology
- Health Authority review and approval procedures
Regulatory systems
- US regulatory system
- EU regulatory system
- Other selected regulatory systems
Product Labeling
- US Package Insert
- EU Summary of Product Characteristics
- Package Inserts and labels, what needs to be included
Regulatory differences between classical drugs and biologics
Promotional activities
Regulatory inspections
Method of working: Lectures (24 hours), self-study, practical and written assignments, tests,
etc. (51 hours)
Good Clinical Practice & Clinical Quality Assurance

Duration: 50 hours, distributed over 3 weeks, simultaneously with module 8 ‘Clinical
Trial Operations’.
Module Director: Elisabetta Di Martino, Head Clinical Quality Assurance, Italy, NVD
Aim: Students will understand the full ICH-GCP requirements and will be able to apply them to
vaccines clinical trials performed by sponsor companies and by investigators internationally.
Content:
Introduction to Good Clinical Practice (GCP)

- Regulatory requirements, ICH-GCP, differences US-EU-Japan-China etc.
- Roles & Responsibilities of Sponsors, Investigators & Monitors
- The importance of the Informed Consent
- Essential documents
Elements of the Clinical Quality System

- Quality Policies and Quality Manual
- Standard Operating Procedures (SOPs)
- Qualification and training of staff
- Qualification of 3rd parties (Contract Research Organisations (CROs)
- Trial Master File
- Auditing: Internal and external auditing, system audits
Regulatory inspections
- Preparation of an inspection (sponsor and site)
- Types, procedure, reports
- Frequent findings
Recommended ICH GCP E6

Reading:
Method of working: Lectures (16 hours), self-study, GCP training*, practical and written
assignments, tests, etc. (34 hours)
* business training may also be part of the internship

Clinical TRIAL Operations

Duration: 125 hours, distributed over 5 weeks, simultaneously with module 7 ‘GCP and
Clinical Quality Insurance’
Module Directors: Deborah Manzo, Head Global Clinical Trial Operations, Global Clinical
Research & Development, NVD
Peter Thomas, Head Systems, Processes & Standards, Global Clinical
Research & Development, NVD
Aim: Students will understand the details of all the steps of operationally preparing and executing
vaccines clinical trials internationally and will be able to apply them to future trials performed
by sponsors and investigators.
Content:
Introduction
- From protocol to clinical study report
- Clinical project management & planning
Trial preparation & start up activities

- Protocol, Informed Consent Form and related documents
- Labelling & packaging of vaccines
• Site qualification, initiation & training
- Use of 3rd parties (CROs)
During trial - Monitoring

- Paper Case Report Forms, Electronic Data Capture, source document verification, serum sample
handling, vaccine accountability, monitoring reports, issue escalation
- Safety reporting, quality & compliance, and site management
End of trial
- Data review and database lock
- Site close-out
- Clinical study report
Documentation
- Essential documents, Trial Master File, document management, archiving
Systems, Processes & Standards

- Trial management systems
- Standard Operating Procedures (SOPs)
- Efficiencies and quality control in processes
Method of working: Lectures (40 hours), self-study, SOP* training, practical and written
assignments, tests etc. (85 hours)
* business training may also be part of the internship
Biostatistics & Clinical Data Management

Module Directors: Pantaleo Nacci, Head Global Statistical Reporting, NVD
Aldo Schepers, Head Clinical Data Management, NVD
Aim: Students will understand the concepts of statistics for clinical trials with vaccines as well as the
concepts of clinical data management.
Content:
Statistical methodology for clinical trials

- Basics, ICH guidelines (E8, E9, E10), EMEA/FDA guidelines
- Descriptive vs. inferential statistics
- Importance of randomization to avoid bias
- Power & sample size calculations for hypothesis testing
- Superiority, equivalence, non-inferiority
- Designs & analytical approaches
- Endpoints (measures and variables), surrogate, clinical
- P-values: statistical and clinical significance
- Statistical analysis plan
- Interim analyses, meta analyses
- Alignment of protocol, data collection and reports
Clinical Data Management

- Case Report Form (CRF) design
- Electronic Data Capture and paper CRF processes and systems
- Database design and setup with edit checks, rules and derivations
- Validation of computerized systems for data management
- Data collection and data cleaning
- Data integration (e.g. lab data transfers)
- Data quality, database lock, post database lock changes
- Adverse Event reporting
- Coding dictionaries (MedDRA, WHO-drug)
Method of working: Lectures (32 hours), self-study, practical and written assignments, tests, etc.
(68 hours)
Policies and recommendations for vaccines in the world

Module Director: Anna Prugnola, Head Public Affairs and Communications, Italy, NVD
Aim: Students will learn that the introduction of new vaccines into the immunisation calendars of
different countries is dependent on a number of international and local factors
Content:
Factors influencing introduction of new vaccines in different countries

- Epidemiology of disease
- Current vaccination calendars in infants & adults
- US
- Europe
- Public health organisation
- Funding mechanisms
Different policies and recommendations in various countries
WHO, UNICEF and GAVI programs
Health economics
Method of working: Lectures (24 hours), self-study, written assignments, tests, etc. (51 hours)

GENERAL INFORMATION FOR STUDENTS
University of Siena:
http://www.unisi.it/internet/home.html
Office of General Student Affairs - section foreign students (“studenti

stranieri”):
http://www.unisi.it/ammin/udss/affari_generali/stranieri_english.htm
Information for Foreign students:

http://www.unisi.it/v0/minisito.html?fld=1767
Go to
> Cost of Living in Siena, Italy
> Health services and Insurance
> Medical facilities
> Meals Sports & leisure facilities
> Local Transportation
Entry visa and temporary residence permit

Other practical information

Accomodation
Italian Ministry of Foreign Affairs

http://www.esteri.it/MAE/EN/Home.htm?LANG=EN
Novartis Vaccines and Diagnostics
Request brochures: “Living in Siena” and “Immigration Handbook” from:
Email: vaccines_master.nvdit@novartis.com
Telephone: Hilary Franklin

Tel: +39 0577 24 3525 or +39 335 750 2395
APPLICATION to UNIVERSITY OF SIENA
Students will need to make a formal application to the University of Siena,

before 27 February 2009. Assistance will be provided by Novartis Vaccines,
where necessary (e.g. for non-Italian students)
See website:
MASTER http://www.unisi.it/postlaurea/master.htm
UNIVERSITARI
Facoltà di Medicina e Chirurgia

Vaccinologia e sviluppo clinico farmaceutico
II° livello
For the course details, click on Bando
For the application forms, click on modulistica (Allegato A e B)
This application will need to contain the following documents*:

• Application Forms on university website (link ‘modulistica (Allegato A e B)’)
- Attachment A / Application form
- Attachment B / “Dichiarazioni sostitutive di Certificazioni” (Statements
replacing formal qualifications)
• For non-Italian students: Modello G http://www.unisi.it/ammin/udss/affari_
generali/2levelcom.htm
• Curriculum vitae
• Photocopy of university degree certificate in medicine and photocopies of
other qualifications
• Photocopy of all the pages of your valid passport or national identity card
• For Italian students, or foreign students resident in Italy: photocopy of
‘codice fiscale’/tax code
• 2 photographs
• Letter of motivation, in English
Citizens from outside the European Union, with legal residence permit in Italy,
please also include:
• Photocopy of valid visa and permit to stay in Italy
Citizens from outside the European Union, resident outside the European Union
• Please present your application to the Italian Embassy or Consulate in your
country of origin (or current country of residence), who will support you with
compiling, translating and validating the documentation and who will submit
your application to the University of Siena.
• For information concerning Entry visa and temporary residence permit,

please consult the University of Siena website: http://www.unisi.it/v0/
minisito.html?fld=1786
* Note: All foreign language documents must be accompanied by an official translation

in the Italian language and also by the “Dichiarazione di Valore” (Declaration of the legal
value of the documents in the country where they were issued) prepared by the Italian
Consulate or Embassy of the zone. Assistance will be provided by Novartis Vaccines
where necessary (e.g. for non-Italian students)
For further information concerning applications, please consult the university website:
http://www.unisi.it/ammin/udss/affari_generali/stranieri_english.htm
REGULATIONS FOR THE ENROLMENT OF FOREIGN AND ITALIAN CITIZENS

WITH DIPLOMAS OR DEGREES OBTAINED ABROAD
REGULATIONS FOR THE ENROLMENT OF FOREIGN AND ITALIAN CITIZENS

WITH RECOGNITION OF PARTIAL STUDIES CARRIED OUT
(ABBREVIATION OF THE DEGREE COURSE)
RECOGNITION OF FOREIGN ACADEMIC DEGREES:
Citizens of the European Union, wherever they may be residents
Citizens from outside of the European Union, with legal residence permit in Italy
Italian citizens with degrees obtained abroad
Citizens from outside of the European Union who are residents abroad
FURTHER CONTACT and INFORMATION:
Email: vaccines_master.nvdit@novartis.com
Telephone: Hilary Franklin

Global Clinical Research & Development department
Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1
53100 Siena, Italy
+39 0577 243525 or +39 335 750 2395

Masters Programme in Vaccinology &
Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1
53100 Siena, Italia

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Siena, Italy

May 2009 - April 2011

Masters Programme in Vaccinology &

The Masters programme is innovative

Participants will receive a 2-year grant

SPONSORS, MODULE DIRECTORS, FACULTY and GUEST SPEAKERS

This Masters Programme in Vaccinology and Pharmaceutical Clinical Development is sponsored by

Coordinator & President Technical-Scientific Committee:.

LOCATION & DURATION

Novartis Vaccines & Diagnostics (NVD) & University of Siena, Italy

SPONSORS, MODULE DIRECTORS, FACULTY and GUEST SPEAKERS

WHY IS THE MASTERS PROGRAMME IN VACCINOLOGY & PHARMACEUTICAL

Minimum entry requirements....................................................................................................................................................3

Application and selection procedure................................................................................................................................3

Overview of modules and credits.........................................................................................................................................4

Academic calendar ..........................................................................................................................................................................4

Details per module............................................................................................................................................................................5

VACCINE DEVELOPMENT process ..........................................................................................................................................5

Vaccine preventable diseases & vaccinology ......................................................................................................5

Immunology & translational medicine.......................................................................................................................6

Vaccine Development Process...........................................................................................................................................7

Clinical development methodology & PHARMACOVIGILANCE.........................................................................8

Good clinical practice & clinical quality assurance..................................................................................10

CLINICAL TRIAL OPERATIONS....................................................................................................................................................11

Biostatistics & clinical data management............................................................................................................12

Policies and recommendations for vaccines in the world.....................................................................13

General information for students...................................................................................................................................14

Application to University of Siena......................................................................................................................................15

Why is the Masters Programme in Vaccinology &

MINIMUM ENTRY REQUIREMENTS

APPLICATION AND SELECTION PROCEDURE

Before 15 December 2008

Students will need to make a formal application to the University of Siena,

Mrs. Hilary Franklin

OVERVIEW OF MODULES AND CREDITS

F I RST Y ear credits key

DETAILS PER MODULE

VACCINE DEVELOPMENT PROCESS

Vaccine Preventable Diseases & VACCINOLOGY

Immunology & Translational Medicine

Identification of vaccine targets

Basis of the immune response

Pre-clinical evaluation of vaccine safety

The analysis of immune responses to vaccines in clinical trials

Vaccine Development Process

History of vaccine production, challenges & advances

Labelling & packaging

Differences between vaccine and pharmaceutical production

Clinical Development MethodologY & PHARMACOVIGILANCE

Drug development life cycle from a regulatory perspective

Regulatory differences between classical drugs and biologics

Good Clinical Practice & Clinical Quality Assurance

Introduction to Good Clinical Practice (GCP)

Elements of the Clinical Quality System

Recommended ICH GCP E6

* business training may also be part of the internship

Evaluation: During module: Written assignments

Clinical TRIAL Operations

Trial preparation & start up activities

During trial - Monitoring

Systems, Processes & Standards

Biostatistics & Clinical Data Management

Statistical methodology for clinical trials