戻る Agenda
Session 10: Aggregate Reporting for Clinical Trials: Development Safety Update Report
Session Chair(s)
Jill W. Buckley, PharmD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, 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.