Module 1 (RMP)

Question 1

What is a Risk Management Plan?

Answer 1

An RMP is a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions.

Question 2

In the US, does the FDA require the submission of a RMP?

Answer 2

No, it does not require it. Instead the FDA may request a REMS, a risk management activity.

Question 3

Are there other countries/regions beside the EEA that require RMPs?

Answer 3

Yes, many countries outside the EEA require RMPs, including Switzerland, Australia, Canada and Brazil.

Question 4

What format can we use to create the EU RMP?

Answer 4

The EU RMP Template - provided by the EMA - is mandatory.

Question 5

Is there a difference between the Core and EU RMP for the same product?

Answer 5

Yes, there may be. The Core RMP represents the company position and the EU RMP is approved by the CHMP.