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Risk Management Plan (RMP) Assessment E-learning Module

This short e-learning module summarises certain keys aspects to consider when undertaking RMP assessment.

After completing this module learners will be able to:

 - Explain what constitutes an important risk as regards the benefit/risk of the product and how to then categorise important risks as either identified risk or potential risks

 - Describe how to identify patient groups for which there is missing information on safety

 - Understand when additional PV activities may be required and what the related activities are

 - Understand when additional risk minimisation measures may be required and what the related activities are.

What does this document cover?

1. Introduction

2. How to prepare for the assessment 

3. Safety specification/categorising risk

4. Safety specification/missing information

5. Pharmacovigilance plan

6. Risk minimisation plan

Target audience

The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.


15 minutes completion time.

Click here to access this e-learning module.

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