戻る Agenda
Session 2: The Development Safety Update Report (DSUR)
Session Chair(s)
Sven Schirp
Head of Global Pharmacovigilance Writing
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
- Scope and content
- Overview of relevant data and data sources
- The concept of safety concerns
- Hot Topic: Clinical Trials Facilitation and Coordination Group (CTFG) and EU Clinical Trial Regulation. Impact on the DSURs
- Develop key messages