Legend:
CC = Vancouver Convention Centre F = Fairmont Waterfront Vancouver
* = applied session ! = JSM meeting theme
Activity Details
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108 * !
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Mon, 7/30/2018,
8:30 AM -
10:20 AM
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CC-West 214
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New Era for Safety Evaluation — Topic Contributed Papers
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Biopharmaceutical Section, Biometrics Section, American Public Health Association
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Organizer(s): Freda Cooner, Sanofi
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Chair(s): Freda Cooner, Sanofi
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8:35 AM
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The Role of Real World Evidence in a Regulatory Environment: Focus on Safety
Estelle Russek-Cohen, US FDA CDER
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8:55 AM
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Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights
Olga Marchenko, Bayer
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9:15 AM
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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
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9:35 AM
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Visual Analytics in the Real World Evidence Data Realm
Melvin Munsaka, AbbVie, Inc.; Kefei Zhou, Theravance Biopharma; Krishan P. Singh, GlaxoSmithKline
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9:55 AM
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Discussant: Judy Li, Regeneron Pharmaceuticals Inc.
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10:15 AM
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Floor Discussion
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