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.
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.
Documents of interest
If you have questions about the content below, please send a question to EMA.
- Work plan for the Pharmacovigilance Inspectors Working Group for 2018
- Work plan for the Pharmacovigilance Inspectors Working Group for 2017
- Work plan for the Pharmacovigilance Inspectors Working Group for 2016
- Work plan for the Pharmacovigilance Inspectors Working Group for 2015
- Work plan for the Pharmacovigilance Inspectors Working Group for 2014
- Work plan for the Pharmacovigilance Inspectors Working Group for 2013
- Work plan for the Pharmacovigilance Inspectors Working Group for 2012
- Work plan for the Pharmacovigilance Inspectors Working Group for 2011
- Work plan for the Pharmacovigilance Inspectors Working Group for 2010
- Work plan for the Pharmacovigilance Inspectors Working Group for 2009
- Work plan for the Pharmacovigilance Inspectors Working Group for 2008
- Annual report of the Pharmacovigilance Inspectors Working Group for 2018
- Annual report of the Pharmacovigilance Inspectors Working Group for 2017
- Annual report of the Pharmacovigilance Inspectors Working Group for 2016
- Annual report of the Pharmacovigilance Inspectors Working Group for 2015
- Annual report of the Pharmacovigilance Inspectors Working Group for 2014
- Annual report of the Pharmacovigilance Inspectors Working Group for 2013
- Annual report of the Pharmacovigilance Inspectors Working Group for 2012
- Annual report of the Pharmacovigilance Inspectors Working Group for 2011
- Annual report of the Pharmacovigilance Inspectors Working Group for 2010
- Annual report of the Pharmacovigilance Inspectors Working Group for 2009
- Annual report of the Pharmacovigilance Inspectors Working Group for 2008