DDA20 Risk Management Plans: Challenges and insights

To deepen and apply knowledge about regulatory requirements and guidance for the Risk Management Plan (RMP). At the end of the workshop, participants will be able to identify the right format and content for each section and deal with some major challenges of RMPs.

Participant profile: Aimed at medical writers with some experience of writing risk management plans (RMPs) or other safety documents (e.g. Periodic Safety Update Reports), or who have attended the foundation workshop on RMPs (the latter may be helpful for those with no experience of RMPs). Participants may also find the workshop “Introduction to Pharmacovigilance writing” (DDF32) helpful.