Convergence in Regulatory Science Across the Strait

Track:
Global Regulatory

Day & Time:
June 25, 1:45PM - 3:15PM

Session Number:
261

Room Number:
253B

Level:
Basic

Type:
Forum

Title:
Convergence in Regulatory Science Across the Strait

Chair(s):
Ning Li, MD,PhD
Vice President, GRA Head, Medical Policy, Asia
Sanofi, China

Description:
In this forum, representatives from the Center of Drug Evaluation from mainland China and the Center for Drug Evaluation from Taiwan will share their views and experience in Good Review Practice (GRP) and IND review. This will form the basis for the discussion of collaboration opportunities and areas of convergence in regulatory science in the two centers.

Learning Objective(s):
Discuss the framework and experience in GRP (good review practices); Identify the principles and practice in IND review.

Presentation(s) & Speaker(s):
Moderator
Ling Su, PhD
Strategic Advisor, Life Sciences
Sidley Austin LLP, China

Point of View from China CDE
Yi Feng
Office of Evaluation Management and Communication
Center for Drug Evaluation of CFDA , China

IND Review: Point of View from China CDE
Zhen Chen, PhD
Deputy Office Director, Office of New Drug Pharmaceutical Science
Center for Drug Evaluation of CFDA , China

Point of View from Taiwan CDE
Hsin-Jung Lee
Reviewer, Division of New Drugs
Center for Drug Evaluation , Taiwan

Point of View from Taiwan CDE
Mey Wang, PhD
Reviewer, Division of New Drugs
Center for Drug Evaluation, Taiwan