Overview
Course instructor Emil Cochino, Scientific Officer, Risk Management Specialist, Office of vaccines and therapies, European Medicines Agency:
This basic and intermediate-level training is aimed primarily at providing marketing authorisation holders and marketing authorisation applicants with practical advice on risk management plans (RMP) drafting using the principles of risk assessment and management included in good pharmacovigilance 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). The Q&A sessions will include the response to questions received in advance or raised during the presentations.
This virtual live course is aimed at the practical aspects of the EU Risk Management Plan (EU-RMP) creation process. We will demonstrate the various uses of the EU-RMP within the lifecycle of medicinal products, medical writing process and RMP management process. It will provide a detailed understanding of the GVP Module V (Rev. 2) with all potential implications for the marketing authorisation holders.
The participants will learn the best practice in medical writing of the EU-RMP. The solutions will be demonstrated in practical exercises included throughout the course.
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