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