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Inspections - Pharmacovigilance

Inspectors Working Group

The Sector draws on the expertise of member states’ inspectorates for the fulfilment of many of its PhV inspections related tasks. This is primarily achieved through the PhV IWG, made up of inspectors involved in PhV inspections related to human and veterinary products, respectively.

The PhV IWG focuses on harmonisation and co-ordination of PhV related activities at Community level. The Group activities are outlined in its work plan. It is involved in the preparation of new and revised guidance and community procedures relating to inspection and PhV. The Sector chairs and provides secretarial support to the PhV IWG. Members provide the expertise for the fulfilment of the group tasks and play a key role in the development of collaborative projects both within the community and externally.

The PhV IWG meets on a regular basis four times a year at EMEA with representatives of the PhV inspectorates of the European Economic Area Member States dealing with human and veterinary medicinal products, respectively, and also observers from candidate countries and Switzerland.

They support the co-ordination of the provision of PhV inspection related advice and provide a link with other groups such as CHMP, CVMP, and PhVWP (H+V). These links include joint meetings with pharmacovigilance assessors and contributions to training of both inspectors and assessors. A PhV IWG / PhVWP subgroup assists in the development of detailed proposals on procedures and guidance. The Mandate of the PhV Inspectors Working Group describes the group's role and activities in more detail. The Human and Veterinary PhV inspection policies developed by this group provide additional information on the legal framework to the inspections, the objectives, the inspection programmes, the different types of inspections, the composition of the inspection team, the focus and preparation of the scope of the inspection and finally about the selection of the sites to be inspected.

The PhV Inspectors maintain a dialogue with GCP and GMP Inspectors on areas of common interest

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