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Sheraton Philadelphia University City

Oct 22, 2018 1:45 PM - Oct 24, 2018 10:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Drug Safety and Pharmacovigilance Across the Product Lifecycle

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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.