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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

597 * Wed, 8/3/2016, 2:00 PM - 3:50 PM CC-W185bc
Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision Making — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians , Section on Risk Analysis
Organizer(s): Weili He, Merck
Chair(s): Jonathan Norton, MedImmune
2:05 PM Practical Considerations for Benefit Risk Assessment and Implementation: Vorapaxar TRA-2P TIMI 50 Case Study Weili He, Merck
2:25 PM Patient Preference in Benefit-Risk Analysis in Medical Device Trials Xuefeng Li, FDA
2:45 PM Benefit-Risk Assessment via Case Studies George Quartey, Genentech ; Qi Jiang, Amgen ; Weili He, Merck
3:05 PM Some Consideration on Endpoint Selection, Weighting Determination, and Uncertainty Evaluation in the Benefit-Risk Assessment in Pharmaceutical Drug Development Haijun Ma ; Qi Jiang, Amgen
3:25 PM Discussant: Martin Ho, FDA/CDRH
3:45 PM Floor Discussion
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