Transcript BLI_PC assay Development

SAPA-GP Webinar Program
A Professional Training Tool for SAPA Members
Non-members are Welcome to Participate
January, 2013
Introduction of Early Drug Development
Dr. Sean Zhang , MD, FCP
Medical Director, Bristol-Myers Squibb (BMS)
February, 2013
Late Stage of Clinical Drug Development, e.g., Ph 2b/3 Studies/Strategies
Dr. Joan Shen, MD. PhD.
Senior Medical Director, China Clinical Lead, PCBU Pfizer Inc.
April, 2013
Regulatory Requirements for the CTA of Multinational Clinical Trials in China
Dr. Cathleen CHAN/陈明
Regulatory Director, Sanofi R&D China
1
SAPA-GP Webinar Program
Regulatory Requirements for the CTA of
Multinational Clinical Trials in China
April. 16th, 2013
Cathleen CHAN, MD.
Regulatory Director, Regulatory R&D China, GRA
Sanofi R&D
2
Background

Dr. Chan is a physician. She starts her career in the sales and marketing in the
pharmaceutical and medical device industry in China

Dr. Chan has worked as the regional head in the sales and marketing for the
North of China, director in regulatory and government affairs for China and
Asia

Dr. Chan gained her broad regulatory experience in Servier and Sanofi, where
she is the head in regulatory, responsible for IND, NDA and LCM for Asia and
China

Dr. Chan has been very devoted to Multinational Clinical Trial Applications for
global and regional clinical trials with the CFDA in the last 10 years

Dr. Chan leads Asian regional and China R&D regulatory team in regulatory
strategy and operation for Sanofi, success in shorting the CTA review timeline
by improving internal practice and collaborating with academy, associations in
China
3
Presentation Outlines:

General Regulatory Requirements for the
Multinational Clinical Trials

Hurdles of CTA for the Multinational Clinical Trials
for IND in China

Description of China CTA Package contents – CFDA
requirement

How to Prepare an China CTA Package Based on
EU/IMPD (Investigational Medical Product Document)
or US/IND package
4