Pharmacovigilance Inspectors Working Group

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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.

Documents of Interest

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Document(s) Language Status First published Last updated Effective Date
Annual report of the Pharmacovigilance Inspectors Working Group for 2016 (English only) adopted 2017-08-08    
Work plan for the Pharmacovigilance Inspectors Working Group for 2017 (English only) adopted 2017-05-17    
Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level (English only)   2017-02-10    
Annual report of the Pharmacovigilance Inspectors Working Group for 2015 (English only) adopted 2016-07-29    
Work plan for the Pharmacovigilance Inspectors Working Group for 2016 (English only) adopted 2016-06-28    
Mandate, objectives and rules of procedure for the Pharmacovigilance Inspectors Working Group (English only)   2009-12-16 2013-07-24  
Pharmacovigilance inspection policy for centralised procedures - medicinal products for human use (English only)   2009-11-27 2013-07-24  
Pharmacovigilance Inspection policy for centralised procedures - medicinal products for veterinary use (English only)   2009-11-27    
Distant / virtual pharmacovigilance inspections of marketing-authorisation holders during a crisis situation - points to consider (English only) adopted 2013-02-18    
Work plan for the Pharmacovigilance Inspectors Working Group for 2015 (English only) adopted 2015-05-04    
Annual report of the Pharmacovigilance Inspectors Working Group for 2014 (English only) adopted 2015-08-12    
Work plan for the Pharmacovigilance Inspectors Working Group for 2014 (English only) adopted 2014-05-22    
Annual report of the Pharmacovigilance Inspectors Working Group for 2013 (English only) adopted 2014-08-06    
Work plan for the Pharmacovigilance Inspectors Working Group for 2013 (English only) adopted 2013-03-14    
Annual report of the Pharmacovigilance Inspectors Working Group for 2012 (English only) adopted 2013-07-25    
Work plan for the Pharmacovigilance Inspectors Working Group for 2012 (English only) adopted 2012-07-13    
Annual report of the Pharmacovigilance Inspectors Working Group for 2011 (English only) adopted 2012-07-13    
Work plan for the Pharmacovigilance Inspectors Working Group for 2011 (English only) adopted 2011-06-16    
Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2010 (English only) adopted 2011-09-02    
Work plan for the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2010 (English only) adopted 2010-04-22    
Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2009 (English only) adopted 2010-04-22    
Work plan for Pharmacovigilance Inspectors Working Group (PhV IWG) for 2009 (English only) adopted 2009-04-20    
Annual report of the Pharmacovigilance Inspector Working Group (PhV IWG) for 2008 (English only) adopted 2009-05-18    
Work plan for Pharmacovigilance Inspectors Working Group (PhV IWG) for 2008 (English only) adopted 2009-04-20