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CC = Vancouver Convention Centre   F = Fairmont Waterfront Vancouver
* = applied session       ! = JSM meeting theme

Activity Details

108 * ! Mon, 7/30/2018, 8:30 AM - 10:20 AM CC-West 214
New Era for Safety Evaluation — Topic Contributed Papers
Biopharmaceutical Section, Biometrics Section, American Public Health Association
Organizer(s): Freda Cooner, Sanofi
Chair(s): Freda Cooner, Sanofi
8:35 AM The Role of Real World Evidence in a Regulatory Environment: Focus on Safety

Estelle Russek-Cohen, US FDA CDER
8:55 AM Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights

Olga Marchenko, Bayer
9:15 AM Propensity-Score-Based Controls: Its Use in Establishing Benefit/Risk of Medicines for Unmet Medical Need

Junjing Lin, AbbVie; Margaret Gamalo-Siebers, Eli Lilly & Co; Ram Tiwari, Center for Devices and Radiologica Health, FDA
9:35 AM Visual Analytics in the Real World Evidence Data Realm
Melvin Munsaka, AbbVie, Inc.; Kefei Zhou, Theravance Biopharma; Krishan P. Singh, GlaxoSmithKline
9:55 AM Discussant: Judy Li, Regeneron Pharmaceuticals Inc.
10:15 AM Floor Discussion