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Session 11: Aggregate Reporting, Part 2
Session Chair(s)
William Gregory, PHD
Senior Director, Safety and Risk Management
Pfizer Inc, United States
- This session will cover the Development Safety Update Report (DSUR) required in the EU and include a description of the modifications required for DSUR submission to FDA in lieu of the IND Annual Report. Abstracts of three sequential DSURs for a mock product progressing through development phases 1, 2, and 3 will be reviewed.
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