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?
2. How to prepare for the assessment
3. Safety specification/categorising risk
4. Safety specification/missing information
5. Pharmacovigilance plan
6. Risk minimisation plan
The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.
15 minutes completion time.
Click here to access this e-learning module.