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.
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Work plan for the Pharmacovigilance Inspectors Working Group for 2020 (PDF/117.13 KB)
Adopted
First published: 03/07/2020
EMA/INS/PhV/359174/2020 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2018 (PDF/162.02 KB)
Adopted
First published: 02/07/2020
EMA/INS/PhV/569203/2019 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2017 (PDF/213.93 KB)
Adopted
First published: 29/04/2020
EMA/INS/PhV/742931/2017 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2018 (PDF/116.77 KB)
Adopted
First published: 23/05/2018
Last updated: 23/05/2018
EMA/INS/PhV/138699/2018 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2016 (PDF/238.53 KB)
Adopted
First published: 08/08/2017
Last updated: 08/08/2017
EMA/INS/PhV/614022/2016 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2017 (PDF/149.09 KB)
Adopted
First published: 17/05/2017
Last updated: 17/05/2017
EMA/IN EMA/INS/PhV/128277/2017 -
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Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level (PDF/228.8 KB)
First published: 10/02/2017
Last updated: 10/11/2020
EMA/INS/PhV/567683/2020, Rev 1 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2015 (PDF/352.84 KB)
Adopted
First published: 29/07/2016
Last updated: 29/07/2016
EMA/INS/PhV/646141/2015 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2016 (PDF/148.87 KB)
Adopted
First published: 28/06/2016
Last updated: 28/06/2016
EMA/INS/PhV/618590/2015 -
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Mandate, objectives and rules of procedure for the Pharmacovigilance Inspectors Working Group (PDF/162.6 KB)
First published: 16/12/2009
Last updated: 24/07/2013
EMA/INS/PhV/163756/2013 Rev. 1 -
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Pharmacovigilance inspection policy for centralised procedures - medicinal products for human use (PDF/133.13 KB)
First published: 27/11/2009
Last updated: 24/07/2013
EMA/INS/PhV/163771/2013, Rev. 1 -
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Pharmacovigilance Inspection policy for centralised procedures - medicinal products for veterinary use (PDF/49.07 KB)
First published: 27/11/2009
Last updated: 27/11/2009
EMEA/INS/PhV/384646/2008 -
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Remote pharmacovigilance inspections of MAHs during a crisis situation - Points to consider (PDF/106.38 KB)
Adopted
First published: 18/02/2013
Last updated: 18/11/2020
EMA/509041/2020 Rev 1 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2015 (PDF/102.12 KB)
Adopted
First published: 04/05/2015
Last updated: 04/05/2015
EMA/INS/PhV/574749/2014 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2014 (PDF/242.04 KB)
Adopted
First published: 12/08/2015
Last updated: 12/08/2015
EMA/INS/PhV/380702/2015 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2014 (PDF/140.92 KB)
Adopted
First published: 22/05/2014
Last updated: 22/05/2014
EMA/INS/PhV/555137/2013 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2013 (PDF/142.71 KB)
Adopted
First published: 06/08/2014
Last updated: 06/08/2014
EMA/INS/PhV/732929/2013 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2013 (PDF/127.92 KB)
Adopted
First published: 14/03/2013
Last updated: 14/03/2013
EMA/INS/PhV/697759/2012 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2012 (PDF/165.52 KB)
Adopted
First published: 25/07/2013
Last updated: 25/07/2013
EMA/INS/PhV/697756/2012 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2012 (PDF/128.79 KB)
Adopted
First published: 13/07/2012
Last updated: 13/07/2012
EMA/INS/PhV/313103/2012 -
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Annual report of the Pharmacovigilance Inspectors Working Group for 2011 (PDF/154 KB)
Adopted
First published: 13/07/2012
Last updated: 13/07/2012
EMA/INS/PhV/193153/2012 -
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Work plan for the Pharmacovigilance Inspectors Working Group for 2011 (PDF/150.26 KB)
Adopted
First published: 16/06/2011
Last updated: 16/06/2011
EMA/INS/PhV/835137/2010 -
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Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2010 (PDF/152.49 KB)
Adopted
First published: 02/09/2011
Last updated: 02/09/2011
EMA/INS/PhV/788454/2009 -
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Work plan for the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2010 (PDF/80.55 KB)
Adopted
First published: 22/04/2010
Last updated: 22/04/2010
EMA/INS/PhV/786484/2009 -
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Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2009 (PDF/115.12 KB)
Adopted
First published: 22/04/2010
Last updated: 22/04/2010
EMA/INS/PhV/788454/2009 -
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Work plan for Pharmacovigilance Inspectors Working Group (PhV IWG) for 2009 (PDF/39.31 KB)
Adopted
First published: 20/04/2009
Last updated: 20/04/2009
EMEA/INS/PhV/472212/2008 -
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Annual report of the Pharmacovigilance Inspector Working Group (PhV IWG) for 2008 (PDF/80.07 KB)
Adopted
First published: 18/05/2009
Last updated: 18/05/2009
EMEA/INS/PhV/114151/2009 -
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Work plan for Pharmacovigilance Inspectors Working Group (PhV IWG) for 2008 (PDF/39.49 KB)
Adopted
First published: 20/04/2009
Last updated: 20/04/2009
EMEA/INS/PhV/63112/2008