Études de cas

Études de cas

Pharmacovigilance - Risk Management Plan

Pharmacovigilance, Regulatory Affairs and Cosmetics, EUDRAC

Risk Management Plan in revision 2 template


To update an established Risk Management Plan (RMP) in the Revision 1 template to the Revision 2 template, as stated in the EMA guidance.

Within the update of the RMP from Revision 1 to Revision 2 was a shift from a ‘shopping list’ / ‘include all’ approach to identifying safety concerns to a more deliberate and evidence-based approach. As a consequence, the RMP Revision 2 now has much narrower scope; it only highlights just the key safety concerns (i.e. those which affect the risk/benefit of the product) and removing safety concerns that become resolved. 

The update also reduced much of the duplication which plagued RMP Revision 1. There is now a greater separation between the RMP and the PSUR; with a focus on minimising duplicate information between the documents. Our personal opinion of this update is that it was a great improvement on the previous version.


As the update of the RMP from Revision 1 to Revision 2 was significant, the exercise was not a simple ‘copy and paste’ job. Although many of the sections in the RMP Revision 1 mirror those in RMP Revision 2, there are several sections which require additional information and re-writing. Therefore communicating this to the providers of information was vital to the success of the project. 

The approach for this project therefore was to first establish what information lay in the current approved RMP that could be used to populate the new template. This would then allow for a detailed comparison of the current information against what was required in the RMP Revision 2 template and the generation of a list of missing information. A request for information was made to the key stakeholders and as this was received, the new RMP was populated and the comparison would begin again. This cycle would be repeated until all information was gathered and the RMP was populated.


The approach used to update the RMP was highly successful as:

  • it allowed the writers of the RMP to continually review the updated guidance and template;
  • it opened continuous dialog with the key stakeholders and information providers, so they better understood the process and what was required;
  • the RMP was compared multiple times against the new guidance and template to ensure all requirements were met;

Vous avez des questions?

Vous avez encore des questions ? Nous sommes là pour vous aider !
Faites-nous savoir comment nous pouvons vous aider à réussir dans le domaine de la réglementation !


Plus de sujets sur Ressources