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Regulatory Submissions, Information, and Document Management Forum


Plenary Session 1: FDA - PDUFA V Update

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

  • Senior Informatics Advisor, Office of the Director, CBER
  • FDA, United States
Plenary Session 1: FDA - PDUFA V Update

Speaker(s)

Adam  Kroetsch

REMS

Adam Kroetsch

  • Research Director, Biomedical Information and Regulatory Policy
  • Duke-Margolis Center For Health Policy, United States
Aaron  Niman, MPH

Sentinel

Aaron Niman, MPH

  • Research Officer, Office of Surveillance and Epidemiology, CDER
  • FDA, United States
Aloka  Chakravarty, PhD

Biomarkers and Adaptive Trial Design

Aloka Chakravarty, PhD

  • Senior Statistical Advisor, Office of the Commissioner
  • FDA, United States
Virginia  Hussong

PDUFA VI Informatics Preview

Virginia Hussong

  • Chief, Data Standards Program, CBER
  • FDA, United States