Accelerating Drug & Clinical Trial Approvals in Asia REGULATOR ...

WORKSHOPS 27 & 30 AUGUST 2013
TUESDAY & FRIDAY
Accelerating Drug & Clinical Trial Approvals in Asia
PRE-CONFERENCE WORKSHOPS | 27 AUGUST 2013
Registration begins 30 minutes before workshop commences. Morning/afternoon refreshments are included; lunch will be served for delegates who
attend the full day i.e. morning and afternoon sessions.
WORKSHOP A: (0900 – 1230)
Developing Successful Bridging Strategies for East Asia
(China, Korea and Japan)
East Asian populations are very similar from various aspects. However,
each country is increasingly requiring clinical data generated in its
own population.
By attending this workshop, participants will find opportunities for
scientific synergies in the East Asian region and will learn possible
regulatory pathways for the future.
Conducted by
So-Jeong Lee, Head of Regulatory, GlaxoSmithKline, Korea
Workshop Outline:
Collaborations in East Asia
Updates on Tripartite (China/Korea/Japan) collaboration
Drug development strategies in East Asia
Opportunities for scientific synergies
Possible regulatory pathways for the future
WORKSHOP B:
(1330 – 1700)
Stability Testing Requirements for Drug Approval in Asia/ASEAN Countries
Stability testing requirements are specific to a region and/or country,
thus with the need of international harmonization. A robust stability
monitoring program ensures a quality product. By attending this
workshop, participants will learn specific requirements for Asia/ASEAN
Countries and find opportunities from possible harmonization.
Conducted by
Nisha Desai, Chief Manager – Corporate Regulatory Affairs, Priamal
Enterprises Limited, India
Workshop Outline:
Stability testing requirements in Asia/ASEAN countries
Country/region specific requirements
Correlation with ICH requirements
Opportunities for harmonization
Challenges & possible solutions
POST-CONFERENCE WORKSHOP | 30 AUGUST 2013
WORKSHOP C: (0900 – 1230)
Overview and Guidelines to Pharmaceutical/Biopharmaceutical
Regulations in India
This workshop provides a comprehensive review of regulatory
guidelines and updates to successful product registration and clinical
trial development in India. Recommended for professionals involved
in regulatory affairs, product registration and clinical development in
India.
Workshop Outline:
Overview of regulatory framework in India
Registration of overseas manufacturers and their products in India
Filings for obtaining an approval for a biological product
Changes in Clinical Trial related regulations
Registration process for Ethics Committees
About your Workshop Leader
Dr. Bobby George, Vice President and Head Regulatory Affairs,
Reliance Life Sciences., India
Dr. George is currently responsible for providing regulatory guidance
and strategic inputs for Reliance Life Sciences’ biopharmaceutical &
pharmaceutical development programs to assure appropriate and
timely regulatory filing and approvals, across different regions. He has
over 14 years of industrial experience, of which the last 10 years have
been with Reliance. During this period, he has been instrumental in
commercializing as many as 7 biosimilars already in India. Many of
these are also under process of registration in the rest of the world
markets.
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaregulatoryasia.com