Working Group on Good Clinical and Good Pharmacovigilance Practices

The  PIC/S Working Group on Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV) was established in 2014. It stems from interest expressed by a number of PIC/S Participating Authorities in extending some PIC/S activities to GCP and GPV.  This Working Group focuses on facilitatating technical co-operation and harmonisation of practices (including the development of guidance and training material), capacity building and information sharing, in particular through the creation of PIC/S Joint Visit inspection groups in these fields.


Chairperson of PIC/S Working Group on GCP & GVP: Mandeep Rai (UK / MHRA)

 

Key Features

The PIC/S GCP & GPV Working Group, founded in 2014, reports to the PIC/S Sub-Committee on Expert Circles (SCEC). Its primary purpose is to facilitate technical co-operation and harmonisation of practices (including the development of guidance and training material), capacity building and information sharing.

The Working Group’s Membership includes more than 12 PIC/S Participating Authorities. It meets regularly via teleconference and has a face to face meeting once a year. Inspectors interested in joining the Working Group are invited to contact the Secretariat.

The Working Group also co-ordinates the PIC/S GCP & GPV Joint Visit Programme, where three visits are carried out by groups of three Inspectors from different PIC/S Participating Authorities over a period of 24 months. The purpose of the visits is:

  • to provide further training for Inspectors through the exchange of experience between them;
  • to provide the means of harmonising inspection procedures and developing inspection guidance; and
  • to ensure and maintain mutual confidence between Inspectors of PIC/S Participating Authorities.

JVP (Joint Visits Programme) Groups in the field of GCP & GPV

For more information on the JVP and on the current groups see below.

How to join a JVP Group in the field of GCP & GPV

Inspectors interested in joining a JVP group in the field of GCP & GPV are invited to contact the Secretariat or the Chair of the Working Group, who will provide an application form and co-ordinate the establishment of a new JVP group.