Overview

This hands-on virtual live training 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.

Featured topics

- Background to the EU Risk Management
- Objectives and Structure of the EU-RMP
- RMP publication on EMA website – drafting early for post-opinion steps; Applicant/MAH requirements for publication
- Identification and Characterisation of Safety Concerns (Modules SVII and SVIII)
- Group Work on Safety Concerns
- Risk Minimisation Measures
- Group Work on Risk Minimisation
- Source Data and Planning Process
- Group Work on Project Management
- Product and Disease/Condition Overviews
- Safety Specification Modules SII-SVI
- Pharmacovigilance Plan and Post-Authorisation Efficacy Studies
- RMPs outside of the EU
- Summary of the EU-RMP and Annexes
- EU-RMP for Generic Medicinal Products (and other “Article 10” Products)

Who should attend?

This virtual live training course is intended for the professionals working within the pharmaceutical industry, service providers, and research institutions in:
- Pharmacovigilance and Drug Safety
- Risk Management
- Regulatory Affairs
- Medical Affairs

Learning objectives

At the conclusion of this virtual live training course, participants will be able to:
- Discuss requirements of the EU Good Pharmacovigilance Practice Module V and Guidance on the format of the RMP
- Define the best medical writing practices for EU RMP and consistency check with other parts of the dossier
- Identify the project management challenges

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EU Risk Management Plan Creation