Assessment of Safety Topics of Interest:

FDA Medical Query, MedDRA SMQ
 or create a custom grouping?

PHUSE 2023 Safety Analytics Webinar Series Presents:
AE Groupings for Assessment of Safety Topics of Interest
September 14, 2023
10 - 11:30 AM Eastern

Dr. Peg Fletcher, Guest Speaker

Dr.  Peg Fletcher joins Mac Gordon, Director Bistatistics-Janssen and Scott Proestel, Acting Associate Director of the Biomedical Informatics and Regulatory Review Science Team at the FDA’s ‘in a panel discussion to explore the emerging challenge of managing and interpreting groups in different settings (e.g., Analysis of Similar Events, signal detection, etc.) and how groupings can be maintained.
Click Here to for Webinar Registration
Dr Peg Fletcher Margaret Fletcher MD PhD
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