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The 7th DIA China Annual Meeting
Session 0601 Managing Post-Approval CMC Changes in China and the US - I
Session Chair(s)
Melly Lin
- Senior Regulatory Manager, CMC Policy,
- Roche(China) Holding Ltd, China
Chi-Wan Chen, PhD
- Executive Director, Global CMC
- Pfizer Inc, United States
Overview of Regulations and Guidelines on Post-Approval CMC Changes for Chemical Drugs in the U.S
Speaker(s)

David LIN, PhD
- Senior Consultant
- Biologics Consulting Group, Inc., United States
Chi-Wan Chen, PhD
- Executive Director, Global CMC
- Pfizer Inc, United States

China Post-Overview of Regulations and Guidelines on Post- Approval CMC Changes for Biotechnological Products in U.S.
Duu-Gong Wu, DrSc, PhD
- Senior Director, Global Regulatory Affairs
- PPD, United States

Zhen Chen
- Professor
- Medicine College, Zhengzhou University, China
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