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Session 0601 Managing Post-Approval CMC Changes in China and the US - I
Session Chair(s)
Melly Lin, MS
CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland
Chi-Wan Chen, PHD
Pfizer, Inc., United States
Speaker(s)
David LIN, PHD
Biologics Consulting Group, Inc., United States
Senior Consultant
Chi-Wan Chen, PHD
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
PPD, United States
Senior Director, Global Regulatory Affairs
Zhen Chen
Medicine College, Zhengzhou University, China
Professor