EFPIA DIA

Regulatory Workshop
11-12 July | New Delhi, India

PROGRAM COMMITTEE
| Overview
Shekhar Natarajan
Head, International Regulatory Strategy, Participants will have the opportunity to interact with
Shire, United Kingdom and regulators from global organizations including WHO,
Chair of EFPIA India Regulatory Network
DCG(I), Indian MoH and Members of European Federation
of Pharmaceutical Industries and Associations (EFPIA
Bente Brunbakke India Regulatory Network), and the Organisation of
Regional Manager-Gulf, India and Egypt, Pharmaceutical Producers of India (OPPI) on key regulatory
Novo Nordisk Pharma and
Vice-Chair of EFPIA India Regulatory Network topics including orphan drug regulation, Clinical trial waiver,
accelerated regulatory pathway, and biological product/
Biosimilars registration in India.
Nagaraj Bannur, PhD
Head-Regulatory Affairs and Patient Safety,
India & Subcontinent, AstraZeneca Pharma India Ltd and
Member of EFPIA India Regulatory Network
| Objectives
Finny Liu
APAC Regional Regulatory Policy Lead,
This workshop aims to bring together regulators and
PDR, Roche, Singapore and implementers to exchange viewpoints on key regulatory
Member of EFPIA India Regulatory Network hot topics.

Kum Cheun Wong

Head Asia Pacific Regulatory and Development
Policy, Novartis Asia Pacific, Singapore and | Who Should Attend
Member of EFPIA India Regulatory Network Regulatory Affairs Professionals
Assessors in Regulatory Authorities
Thean Soo (TS) Lo
Director, Asia Pacific Regulatory Policy Lead,
Global Regulatory Affairs, Janssen Asia Hotel Information
Pacific, J&J Singapore and
Member of EFPIA India Regulatory Network The Taj Mahal Hotel, New Delhi
Number One, Mansingh Road
New Delhi - 11 00 11, Delhi, India
Phone: + 91 11 6651 3686

DIA India Pvt. Ltd.

Office Number 250, Unit No 1, Level 2, B Wing | Times Square, Andheri Kurla Road | Andheri East, Mumbai 400059 INDIA
+91 22. 6608 9588 (tel) | +91 9029098844 (cell) | www.DIAglobal.org | India@DIAglobal.org
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 DAY ONE | TUESDAY | 11 JULY

8:00AM Registration and Welcome Coffee

9:00AM Session 1
Welcome Message

Chair: S
 hekhar Natarajan
Head-International Regulatory Strategy, Shire, United Kingdom
Vice-Chair: Industry Representative Invited

Steps Undertaken/Planned by DCGI in India to Ensure Fast Access to New Treatments

Keynote Speaker: Regulator Invited
Strengthening of Regulatory System as per WHO Good Regulatory
Keynote Speaker : Mike Ward
Regulatory Systems Strengthening Coordinator,
World Health Organization, Switzerland
10:30AM Coffee and Networking Break

11:00AM Session 2
PIII Clinical Trial Waiver in India

Session Chair: Nagaraj Bannur, PhD

Head-Regulatory Affairs & Patient Safety India & Subcontinent,
AstraZeneca Pharma India Ltd

Feedback on how Clinical Trials Waiver Requests are Viewed and Handled by the Ministry of Health
Regulator Invited

Current Status and Associated Case Studies

Suneela Thatte, Global Operations Vice President, Quintiles Research, India

12:30PM Luncheon

14:00PM Session 3
Collaborative Procedure in the Assessment and Accelerated National Registration of
Pharmaceutical Products Approved by Stringent Regulatory Authorities
World Health Organization Representative Invited

15:30PM Coffee and Networking Break

16:00PM Session 4
Accelerated Regulatory Pathway in India
Session Chair: Finny Liu
APAC Regional Regulatory Policy Lead, PDR, Roche, Singapore

OPPI Stand on This and how the Current Process can be Further Simplified
Suresh Menon, Chief Scientific Officer, Novartis, India

Inspiration from Other Regions and Comparison Towards India

Industry Representative Invited

18:00PM Panel Discussion

18:45PM END OF DAY ONE

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 DAY TWO | WEDNESDAY | 12 JULY

8:00AM Registration and Welcome Coffee

9:00AM Session 5
Welcome Message

Chair: S
 hekhar Natarajan
Head-International Regulatory Strategy, Shire, United Kingdom
Vice-Chair: Industry Representative Invited
WHO Guideline on Procedures and Data Requirements for Changes to Approved Bio-Therapeutic Products
Mike Ward, Regulatory Systems Strengthening Coordinator, World Health Organization, Switzerland

Plans for Orphan Drug Regulation Implementation in India

Soumya Swaminathan, Director General ICMR and Secretary of Department of Health, India

Review and Development of Biological Products Approval Guidance and Future Plans
Regulator Invited

10:30AM Coffee and Networking Break

11:00AM Session 6
Orphan Drug Regulation

Session Chair: Shekhar Natarajan

Head-International Regulatory Strategy, Shire, United Kingdom

Brief Overview on OD Regulation in US/EU and Other Developed Markets

Shekhar Natarajan, Head of International Regulatory Strategy, Shire, UK

How Does Industry Handle Orphan Indications Today and Associated Case Studies?
Bhasker Sonowal, Head of External Affairs, Shire, India

12:30PM Lunch

14:00PM Session 7
New Biological Product Registration/Biosimilar Regulation

Session Chair: Finny Liu

APAC Regional Regulatory Policy Lead, PDR, Roche, Singapore

Review of Indian Guideline and any Concerns Regarding Concerns and Similarities with ROW
Industry Representative Invited

Comparison with Biosimilar Guidelines Available in Other Major Markets

Industry Representative Invited

15:30PM Coffee and Networking Break

16:00PM Session 8
An Overview of Early-Access or Named Patient Access Procedure
Session Chair: Viraj Suvarna
Medical Director, Boehringer Ingelheim, India

17:00PM Panel Discussion

17:45PM Closing Words

18:00PM END OF WORKSHOP

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 EFPIA - DIA Regulatory Workshop
Event I.D. 17661
The Taj Mahal Hotel, New Delhi | 11-12 July 2017

VENUE: CANCELLATION POLICY: ON OR BEFORE JULY 4, 2017

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