Pharmacovigilance Inspectors Working Group

The Pharmacovigilance Inspectors Working Group (PhV IWG) was established by the European Medicines Agency with the remit to focus on harmonisation and co-ordination of PhV-related activities at the European Union (EU) level.

In particular, PhV IWG is involved in the preparation of new and revised guidance and EU procedures relating to PhV inspections.

The group provides a link with other groups, such as:

• Committee for Medicinal Products for Human Use (CHMP);
• Committee for Medicinal Products for Veterinary Use (CVMP) and its Pharmacovigilance Working Party;
• Pharmacovigilance Risk Assessment Committee (PRAC).

These involve joint meetings with pharmacovigilance assessors and contributions to training of inspectors and assessors.

The PhV inspectors maintain a dialogue with the inspectors of good clinical practice and good manufacturing practice.

Mandate and work programme

More information on the PhV IWG's role and activities is available in the Human and Veterinary PhV inspection policies and in the group's mandate, workplan and annual report.

Composition

The Pharmacovigilance Inspectors Working Group draws on the expertise of Member States' inspectorates.

PhV IWG meets four times a year at the European Medicines Agency with the representatives of PhV inspectorates involved in inspections related to human and veterinary products, across the European Economic Area. Observers from candidate countries and Switzerland also participate in the meetings.

The Compliance and Inspections Department chairs and provides secretarial support to the group.

The work of the Working Group is supported by PhV assessors subgroup.