PRAC Interest Group on Measuring the Impact of Pharmacovigilance Activities (PRAC IG Impact)

The Pharmacovigilance Risk Assessment Committee (PRAC) Interest Group on Measuring the Impact of Pharmacovigilance Activities (PRAC IG Impact) oversees the implementation of the PRAC impact strategy.

The PRAC set up the working group in 2016.

For more information, see:

• Working parties and other groups

Responsibilities

The working group's main tasks include:

• Advising on key activities to assess the impact of pharmacovigilance, in particular through studies on risk minimisation measures
• Prioritising key PRAC regulatory decisions to guide the scope of impact research conducted within the European medicines regulatory network
• Contributing to the assessment of the feasibility of multi-database studies measuring the impact of pharmacovigilance activities
• Advising on the revision of PRAC impact strategy in light of accumulated experience

For more information, see:

• Measuring the impact of pharmacovigilance activities

Composition

In addition to PRAC members, the working group is composed of:

• National competent authorities experts;
• EMA experts with special interest in regulatory impact research.