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Risk Management Plans: Challenges and insights

Level:
Advanced
Area:
Drug Development
Code:
DDA20
Duration:
03:30:00
Workshop 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.
Objective:
To learn about the regulatory requirements and the main changes introduced by the revision of the RMP guidance and template (expected in January 2017). 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 the new RMP format.
Content:
This workshop will provide an overview of the changes introduced by the revision of the Good Pharmacovigilance Practice (GVP) module V on Risk Management Systems, particularly focusing on the RMP format.Participants will learn how to choose the right format for RMPs in different scenarios. A brief overview of the structure and contents of the RMP according to the revised GVP Module V will be provided. Major challenges of the new format will be explored in exercises. Particular emphasis will be given to the new definition of important risks, to common pitfalls when updating existing RMPs written in the old format, and to the summary of the RMP for the lay public.