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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

Melly Lin

  • Senior Regulatory Manager, CMC Policy,
  • Roche(China) Holding Ltd, China
Chi-Wan  Chen, PhD

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

David LIN, PhD

  • Senior Consultant
  • Biologics Consulting Group, Inc., United States
Chi-Wan  Chen, PhD

Chi-Wan Chen, PhD

  • Executive Director, Global CMC
  • Pfizer Inc, United States
Duu-Gong  Wu, DrSc, PhD

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

Zhen Chen

  • Professor
  • Medicine College, Zhengzhou University, China

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