EU Risk Management Plan Creation Training Course

This practical virtual live training course will teach the EU RMP creation skills from both industry and regulatory perspective, including the project management, medical writing, design, and maintenance of the document. It also includes preview of the GVP V Rev 3 and RMP Template Rev 3.

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
• Product and Disease/Condition Overviews
• Safety Specification Modules SII-SVI
• Identification and Characterisation of Safety Concerns (Modules SVII and SVIII)
• Group Work on Safety Concerns
• Source Data and Planning Process
• Group Work on Project Management
• Pharmacovigilance Plan and Post-Authorisation Efficacy Studies
• RMPs outside of the EU
• Summary of the EU-RMP and Annexes
• Risk Minimisation Measures
• Group Work on Risk Minimisation
• EU-RMP for Generic Medicinal Products (and other “Article 10” Products)
• Publication of EU RMPs
• Preview of the GVP V Rev 3 and RMP Template Rev 3

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