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Boston Convention and Exhibition Center

2013年6月23日 (日) 午前 8:30 - 2013年6月27日 (木) 午後 12:45

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Convergence in Regulatory Science Across the Strait

Session Chair(s)

Ning  Li, MD, PHD

Ning Li, MD, PHD

Vice President, Head of Asia Regulatory and Medical Policy

Sanofi, China

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

Speaker(s)

Ling  Su, PHD

Moderator

Ling Su, PHD

Yeehong Business School, China

Research Fellow

Yi  Feng

Point of View from China CDE

Yi Feng

Fountain Medical Development Ltd., China

SVP, Medical and Reg Affairs

Zhen  Chen, PHD

IND Review: Point of View from China CDE

Zhen Chen, PHD

Center for Drug Evaluation of CFDA , China

Deputy Office Director, Office of New Drug Pharmaceutical Science

Hsin-Jung  Lee

Point of View from Taiwan CDE

Hsin-Jung Lee

Center for Drug Evaluation , Taiwan

Reviewer, Division of New Drugs

Mey  Wang, PHD

Point of View from Taiwan CDE

Mey Wang, PHD

Center for Drug Evaluation, Taiwan

Reviewer, Division of New Drugs

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