戻る Agenda
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.