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