Pre-Marketing Clinical Safety

DIA presents an intensive course for professionals involved in management of safety information from clinical trials in the EU. Participants will be guided through all the regulations and guidelines pertinent to pre-marketing safety in the EU. The course offers overview of all the major current methodological approaches and hands-on solutions for day-to-day challenges. Attendees will learn how to produce Development Safety Update Reports (DSURs), and how to bridge a Development Risk Management Plan, EU-RMP and REMS to be ready for a marketing authorisation application.