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Session Chair(s)
Ivan S. F. Chan, PHD
Executive Director, Biostatistics, Late Development Statistics
Merck Research Laboratories, United States
Steve Wilson, PHD
Senior Staff Fellow, OB, OTS, CDER
FDA, United States
Speaker(s)
Data Transparency: Protecting the Patient and the Sponsor
Jonathan S. Hartzel, PHD
Merck and Co., Inc. , United States
Biometrician
FDASIA/PDUFA V, Data Standards and Statistical Review: An Update
Benjamin Peter Behrang Vali, MS
FDA, United States
Regulatory Affairs Officer and Project Manager, DGIEP, OND, CDER
Increased Clinical Data Transparency: Building Trust and Advancing Public Health
Jesse Berlin, DRSC
Johnson & Johnson, United States
Senior Vice President, Epidemiology