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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

237 * Mon, 8/1/2016, 2:00 PM - 3:50 PM CC-W196a
Quantitative Sciences for Safety Monitoring and Confirmatory Safety in Clinical Development — Topic Contributed Papers
Biopharmaceutical Section , Scientific and Public Affairs Advisory Committee , Committee on Applied Statisticians
Organizer(s): Judy X. Li, FDA
Chair(s): Qi Jiang, Amgen
2:05 PM ASA Biopharm's Safety Monitoring Subteam: Survey of Statisticians, Thought Leaders, and Regulatory Guidance Mike Wright Colopy, UCB Bioscience ; Susan Duke, AbbVie
2:25 PM Safety-Monitoring Methodology in the Premarketing Setting Melvin Munsaka, Takeda Development Center
2:45 PM Statistical Considerations for Cardiovascular Outcome Trials in Patients with T2DM Maria Matilde Sanchez-Kam, Arena Pharmaceuticals
3:05 PM Discussant: William Wang, Merck
3:25 PM Discussant: Ram Tiwari, FDA/CDER/OT/OB
3:45 PM Floor Discussion
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