With the EU Clinical Trial Regulation (EU No. 536/2014) fully in force, safety reporting has become more centralized, more visible, and less forgiving. Whether you’re managing a first-in-human trial or scaling across member states, getting the details right on XEVMPD, SUSARs, and DSURs is no longer optional.
This webinar breaks down what clinical and regulatory teams need to know to stay compliant — and confident — when navigating safety reporting under CTR.
Here’s what you’ll learn:
- XEVMPD and how it connects to your CTIS submission
- SUSARs: what they are and how to report them correctly
- DSUR essentials and the role of the RSI in annual safety updates
Built for clinical operations, regulatory affairs, and safety leads who want clarity on safety reporting essentials — without the jargon.
- Date: May 8th
- Time: 16:00 – 16:45 CET
Speaker:
- Bianca Schrans-Stassen: Graduate from Radboud University in Nijmegen, the Netherlands holding a PhD in molecular biology, Bianca Schrans is a seasoned pharmacovigilance expert with over 20 years of experience. Her career in pharmacovigilance started at former Organon where she gained knowledge on post-marketing as well as clinical development pharmacovigilance. As of 2011 she entered into the pharmacovigilance consultancy business working for several companies on different projects like company core data sheet owner, setting up a pharmacovigilance system for generic companies and providing support with Extended EudraVigilance medicinal product dictionary (XEVMPD) entries of medicinal product data on authorized as well as investigational medicinal products. She supports SUSAR reporting in the EU via EVWEB and compiles and writes developmental safety update reports on request of customers.
Register now and strengthen your clinical trial reporting foundation!
