Understanding FDA Guidance Development and Implementation —Delivered by Asian Women Scientists for FDA (AWS4FDA)
Former Director, Office of Drug Evaluation III, CDER, FDA
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Audrey Jia, PhD, Former Senior CMC Reviewer, CDER, FDA
Sharon Liang, MD PhD RAC, Former Device Team Leader, CDRH, FDA
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Owner-manager, Florence Houn MD MPH LLC
https://www.amnow.com/q7envc01 Former Director, Office of Drug Evaluation III, CDER, FDA
https://faradayvp.com/nm6t12g2naf Former VP for Global Regulatory Science at Bristol-Myers Squibb/Celgene
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Global Regulatory Affairs Director, AstraZeneca
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https://www.amnow.com/ok9o5un3 FDA CDER Excellence in Mentoring Award
https://popcultura.com.br/5e4lkuj14ms FDA CDER Leadership Excellence Award Board Member,
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Former Senior IVD and CMC Reviewer, CBER, FDA
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https://ontopofmusic.com/2022/09/2vnvzt57 Principal Consultant, DataRevive USA LLC
Former Senior CMC Reviewer, CDER, FDA
20 years of combined experience in biologic drug development and regulatory review
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MDIC RWE Working Group member for COVID-19 IVD tests FDA Steering
Committee member and Lead for Precision Medicine Initiative (PMI) Bioinformatics Working Group
FDA Commissioner’s Special Citation Award
FDA Outstanding Service Award
Panelist: Jing Zhang, MD PhD
CMO, Axter Therapeutics
Executive Director, CNS, R&D, AbbVie/Allergan Director, CNS, R&D, Janssen (J&J)
Former Clinical Team Leader, CDER, FDA
More than 10 years drug regulatory experience
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Expert in CNS new drug development