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Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Session Chair(s)
Greg Ball, PHD
Safety Data Scientist
ASAPprocess, United States
We will leverage the PHUSE Safety Analytics Education library and the recent AE Groupings in Safety (AEGiS) white paper to operationalize the FDA Medical Queries and Standard Safety Tables and Figures (ST&Fs).
Learning Objective : Discuss how to operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures (ST&Fs) in safety reporting; Identify ways to use the PHUSE Safety Analytics Education Library to enhance safety analytics; Describe ways to leverage the PHUSE AE Groupings in Safety (AEGiS) white paper to improve adverse event groupings in safety analysis.
Speaker(s)
PHUSE AE Groupings in Safety (AEGiS) White Paper
Robert (Mac) Gordon, MS
Johnson & Johnosn Innovative Medicines, United States
Director, Biostatistics
FDA Medical Queries (FMQs)
Linda Jeng, MD, PHD
FDA, United States
Associate Director for Biomedical Informatics
PHUSE Safety Analytics Education Library
William Palo, MS
AbbVie, United States
Director, Safety Statistics
Standard Safety Tables and Figures (ST&Fs)
Y. Veronica Pei, MD, MED, MPH
FDA, United States
Lead Physician, Associate Director, Biomedical Informatics and Regulatory Review
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