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Session 10: Aggregate Reporting for Clinical Trials: Development Safety Update Report
Session Chair(s)
Mark Vieder, MBA, RPh
Vice President, Drug Safety and Pharmacovigilance
Biorasi, LLC, 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 the DSUR submission to FDA in lieu of the IND Annual Report.
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