Good Clinical Practice Inspectors Working Group

The GCP Inspectors Working Group focuses on harmonisation and co-ordination of GCP related activities at Community level. The Group activities are outlined in its PDF icon work plan .

It is involved in the preparation of new and revised guidance on GCP and community procedures relating to inspection.

The Sector chairs and provides secretarial support to the GCP Inspectors Working Group.

Members provide the expertise for the fulfillment of the group tasks and play a key role in the development of collaborative projects both within the community and externally.

The GCP Inspectors Working Group meets four times a year, at EMA, with representatives of the GCP inspectorates of the European Economic Area Member States, observers from candidate countries and Switzerland.

They support the co-ordination of the provision of GCP advice and provide a link with other groups such as CHMP, CVMP, EWP and PhVWP. These links include joint meetings with clinical and pharmacovigilance assessors and contributions to training of both inspectors and assessors. The PDF icon mandate of the GCP Inspectors Working Group describes the group's role and activities in more detail.

The GCP inspectors maintain a dialogue with GMP inspectors on areas of common interest in particular the interface between GMP for investigational medicinal products and GCP.

A GCP / GMP subgroup assists in the interpretation of GMP in a number of specified areas (see workplan).

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