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项目委员会
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Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
Astellas, United States -
Betsy Fallen, RN Consultant
BAFallen Consulting LLC, United States -
Sarah Powell, RAC President
Powell Regulatory Services, United States -
Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
Epista Life Sciences, United States -
Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States -
Jake Doran Head of Digital
Lykos Therapeutics, United States -
Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Mark A. Gray Senior Project Manager, DSB, CBER
FDA, United States -
Ginny Hussong Branch Chief, Data Standards, CBER
FDA, United States -
Andrew Marr, PhD Managing Director
Marr Consultancy Ltd, United Kingdom -
Thomas Noto Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States -
Daniel Orfe, MS President and CEO
Regulatory eSubmissions, LLC, United States -
Michiel Stam Director Regulatory Information Management
Qdossier - A Celegence Company, United Kingdom -
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States
