The European Medicines Agency has published significant changes to EU pharmacovigilance guideline on risk management plans (GVP Module V and RMP Template Rev 2). These updates aim to further clarify the activities on which a risk management plan should focus to ensure optimal health promotion and protection based on a risk-proportionate planning of activities that directs resources to areas where the need for additional information and risk minimisation is greatest.
This Information Day is aimed primarily at providing marketing authorisation holders (MAHs) and marketing authorisation applicants (MAAs) with practical advice on RMP drafting using the principles of risk assessment and management included in GVP V Rev 2.
Content requirements and procedural advice for RMP submission will be presented with practical examples provided, based on frequent questions from applicants, assessors, and EMA Risk Management Specialists. Highlights will include types of products with different legal basis application (e.g. generics, fixed dose combination products, biosimilars).

Feedback from the Industry will be discussed and EMA and PRAC view on topics raised will be provided.

The Q&A and panel discussion sessions will include the response to questions received in advance or raised during the presentations.

Participants are invited to send questions related to their experience with implementation of Rev 2 by 10 December to emaevents@diaglobal.org.