PRAC: Working parties and other groups of interest

The Pharmacovigilance Risk Assessment Committee (PRAC) consults its working parties and other groups on scientific and regulatory issues when needed. It also delegates specific tasks to them, such as pharmacovigilance activities or drafting scientific guidance. These groups provide specialised expertise in their respective fields.

For more information, see:

• Working parties and other groups

Other working parties and associated groups

The following working parties can be consulted to provide advice to EMA and its human scientific committees, including PRAC, on all matters of interest in relation to medicines:

• Healthcare Professionals' Working Party
• Patients' and Consumers' Working Party

The current PRAC working groups are:

• Granularity and Periodicity Advisory Group (GPAG)
• PRAC Interest Group on Measuring the Impact of Pharmacovigilance Activities (PRAC IG Impact)
• PRAC Risk Minimisation Alliance (PRISMA) Group
• Signal Management Review Technical (SMART) Working group 

The Pharmacovigilance Inspectors Working Group (PhVIWG) further supports PRAC's work:

• Pharmacovigilance Inspectors Working Group

Other established CHMP working parties, as well as other relevant groups, may also support PRAC when needed:

• CHMP: Working parties and other groups

Drafting groups

PRAC sets up ad-hoc drafting groups as needed to develop specific guidance documents or other PRAC-related work. 

Each drafting group is composed of experts drawn from EMA, PRAC members and the European expert list, when needed.

For more information, see:

• European expert list