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The 7th DIA China Annual Meeting


Session 0602 Managing Post-Approval CMC Changes in China and the US - II

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

  • Pfizer, Inc., United States

Experience Sharing on Multiple Sites for Biologics in Taiwan

Speaker(s)

Jofeng  Chi

Experience Sharing on Multiple Sites for Biologics in Taiwan

Jofeng Chi

  • Section Chief, Taiwan
  • Food and Drug Administration Ministry of Health and Welfare, China
Chi-Wan  Chen, PhD

Managing post-approval changes for chemical drugs-case studies (EN&CN)

Chi-Wan Chen, PhD

  • Pfizer, Inc., United States
Andrew  Chang, PhD

Managing Post-Approval CMC Changes for Biologics in a Global Market – Case Studies (EN&CN)

Andrew Chang, PhD

  • Vice President, Quality and Regulatory Compliance
  • Novo Nordisk, United States

Contact us

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