Sessions Were Renumbered as of May 19.
Legend:
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
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
