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Session 0602 Managing Post-Approval CMC Changes in China and the US - II
Session Chair(s)
Melly Lin
CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland
Chi-Wan Chen, PhD
Pfizer, Inc., United States
Speaker(s)
Experience Sharing on Multiple Sites for Biologics in Taiwan
Jofeng Chi
Food and Drug Administration Ministry of Health and Welfare, China
Section Chief, Taiwan
Managing post-approval changes for chemical drugs-case studies (EN&CN)
Chi-Wan Chen, PhD
Pfizer, Inc., United States
Managing Post-Approval CMC Changes for Biologics in a Global Market – Case Studies (EN&CN)
Andrew Chang, PhD
Novo Nordisk, Inc., United States
Vice President, Quality and Regulatory Compliance
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