Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.
The Development Safety Update Report (DSUR) is the common standard for annual clinical trial safety reporting in the ICH regions (Europe, Japan and the US). This webinar will review practical experience with the DSUR from a medical writer’s perspective. The session will include case studies illustrating lessons learned for DSUR preparation. Common challenges, like DSUR scheduling and DSURs for combination vs mono-substances will be discussed.
- Content and timeline parameters for a compliant DSUR
- Overcoming common pitfalls of preparing a DSUR
- Best practices for preparing and submitting DSURs
Head of Global Pharmacovigilance Writing
Boehringer Ingelheim Pharma GmbH & Co. KG