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Program Committee
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Betsy Fallen, RN Consultant
BAFallen Consulting LLC, United States -
Gary M. Gensinger, MBA Senior Advisor for Records, OSP, OBI, CDER
FDA, United States -
Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
Astellas, United States -
Mark A. Gray Senior Project Manager, DSB, CBER
FDA, United States -
Ginny Hussong Branch Chief, Data Standards, CBER
FDA, United States -
Daniel Orfe, MS President and CEO
Regulatory eSubmissions, LLC, United States -
Emily Onkka Senior Director, Regulatory Affairs
Pfenex, Inc., United States -
Laura J. Sherman, MBA Training Partner, Clinical Business Operations
Vertex Pharmaceuticals, Inc., United States -
Stacy Tegan Program Director
Transcelerate Biopharma, Inc., United States -
Hans van Bruggen, MSc CSO
Qdossier, a Celegence Company, Netherlands
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