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Chi-Wan Chen

Pfizer Inc
Executive Director, Global CMC
Dr. Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on China and Asia Pacific. She has made numerous presentations on regulatory and CMC topics on China in these countries. Prior to joining Pfizer in 2008, Dr. Chen had served in the U.S. FDA for more than 21 years and held several management positions in the Center for Drug Evaluation and Research (CDER), including Deputy Director in the Office of New Drug Quality Assessment. She represented CDER on the ICH Q1AR, Q3AR/Q3BR, and Q8R Expert Working Groups between 1998 and 2008 and managed the CDER Quality-by-Design Pilot Program in 2005-08.

My Speakers Sessions

Tuesday, June 20