European Medicines Agency information day on risk management planning: implementation of GVP V and RMP template rev. 2 guidance
Location: European Medicines Agency, London, UK
This information day is aimed primarily at providing marketing authorisation holders and marketing authorisation applicants with practical advice on risk management plans (RMP) drafting usingthe principles of risk assessment and management included in good pharmacovigilnce practice (GVP) module 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 European Medicines Agency (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 Pharmacovigilance Risk Assessment Committee (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.