×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
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 : Operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures (ST&Fs) in safety reporting; Utilize the PHUSE Safety Analytics Education Library to enhance safety analytics; 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
Standard Safety Tables and Figures (ST&Fs)
Representative Invited
FDA, United States
PHUSE Safety Analytics Education Library
William Palo
Takeda Global Research & Development Center, Inc., United States
FDA Medical Queries (FMQs)
Representative Invited
FDA, United States
Have an account?