Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes

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: www.fda.gov/dr...
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