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Plenary Session 1: FDA - PDUFA V Update
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
Plenary Session 1: FDA - PDUFA V Update
Speaker(s)
Adam Kroetsch
Research Director, Biomedical Information and Regulatory Policy, Duke-Margolis Center For Health Policy, United States
REMS
Aaron Niman, MPH
Research Officer, Office of Surveillance and Epidemiology, CDER , FDA, United States
Sentinel
Aloka Chakravarty, PHD
Director, Data Analytics, Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Biomarkers and Adaptive Trial Design
Ginny Hussong
Branch Chief, Data Standards, CBER, FDA, United States
PDUFA VI Informatics Preview
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