This webinar discussed how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application.

Timestamps

01:26 – Common Mistakes When Pooling Clinical Trial Safety Data

41:14 – FDA Type C Meetings on ISS Safety Analysis Strategy and Related Data Requirements

54:39 – Brief Remarks

59:52 – Q&A Discussion Panel

Speakers | Panelists:

Mary Nilsson
Executive Director-Statistics
Safety Analytics Working Group
FDA | Pharmaceutical Users Software Exchange (PHUSE)
Eli Lilly

Veronica Pei, M.D., MPH, MEd
Lieutenant Commander (LCDR) | United States Public Health Service (USPHS)
Acting Associate Director
Biomedical Informatics and Regulatory Review (BIRRS)
Division of Biomedical Informatics, Research, and Biomarker Development (DBIRBD)
Office of Drug Evaluation Sciences (ODES)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER) | FDA

Gregory Levin, Ph.D.
Associate Director for Statistical Science and Policy
Office of Biostatistics (OB)
Office of Translational Sciences (OTS)
CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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