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Activity Details

497 * Wed, 8/2/2017, 10:30 AM - 12:20 PM CC-315
Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Susan P Duke, Safety Statistics Consultant
Chair(s): Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
10:35 AM Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance Kefei Zhou, Theravance Biopharma ; Melvin Munsaka, Safety Statistics and Observational Res Analytics, Takeda
10:55 AM Analysis of Clinical Trial Adverse Event Data Michael Fries, CSL Behring ; Judy X. Li, Regeneron Pharmaceuticals ; Matilde Sanchez-Kam
11:15 AM When to Alert a Safety Assessment Committee - Approaches and Examples Brian Waterhouse
11:35 AM Discussant: Barbara Hendrickson, TA Head, Immunology, Pharmacovigilence and Patient Safety, AbbVie
11:55 AM Discussant: Yong Ma, FDA/CDER/OTS/OB/DB VII
12:15 PM Floor Discussion
 
 
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