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Plenary Session 1 - FDA Update
Session Chair(s)
Gary M. Gensinger, MBA
Senior Advisor for Records, OSP, OBI, CDER
FDA, United States
Plenary Session 1 - FDA Update
Speaker(s)
CDER eCTD Update
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
Moving Toward Required Study Data Standards, A Regulatory Update
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
Identification of Medicinal Products (IDMP): Update on Technical Specifications, Maintenance, and Implementation Activities
Vada Perkins, DrSc, MSc
Boehringer-Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Paul M. Loebach
FDA , United States
Team Leader, Drug Registration and Listing Program, OC, CDER
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