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Overview

DIA presents an intensive course for professionals involved in the 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 an 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 Risk Management Plan (EU-RMP), and Risk Evaluation and Mitigation Strategies (REMS) to be ready for a marketing authorisation application.