PRAC Risk Minimisation Alliance (PRISMA) Group

The Pharmacovigilance Risk Assessment Committee (PRAC) Risk Minimisation Alliance (PRISMA) group advises PRAC on factors that support the effective implementation of risk minimisation measures in healthcare.

The group focuses on the healthcare systems perspective on risk minimisation measures. It does not discuss ongoing PRAC assessments.

The PRAC set up the working group in 2022.

For more information on EMA's working parties and other groups, see:

• Working parties and other groups

Responsibilities

The working group’s tasks include:

• Providing insights on risk minimisation options and their practical implementation in healthcare, reflecting the perspectives of patients and healthcare professionals
• Enhancing PRAC’s engagement with patients, healthcare professionals, and related organisations

Composition

The PRISMA group is composed of:

• PRAC members and alternates, including patient and healthcare professional members;
• National competent authorities experts;
• EMA experts.

The group may also include members from relevant European organisations, such as those representing general practitioners and pharmacists. 

When selecting experts for this group, the best available expertise needed to meet the group’s commitments is taken into account.