Expert Circle on Good Clinical Practices

The PIC/S Expert Circle on Good Clinical Practices (GCP) was established in 2023. The intention of the Expert Circle is to provide opportunities for training, harmonization and share best practices with working groups set up to focus on key topics and emerging areas within clinical trials (both human and veterinary as applicable).

Chairperson of PIC/S Expert Circle on GCP: Mandy Budwal-Jagait (United                        Kingdom / MHRA) 

Structure

The GCP Expert Circle organizational structure and mandate was finalized to include: (1) Working Group on Data governance; (2) Working Group on Risk Adapted Approaches in Clinical Trials, tasked with designing, developing, and executing a meeting over the next 18–24 months focused on providing training and opportunities to obtain knowledge and competence to inspect these key areas; and (3) Joint Visit Program, formed to coordinate remote and in-person joint visits in which inspectors from three different countries are matched up to observe inspection conduct in each country.

Key Features

The goals of the Expert Circle on GCP are to:

• Design, develop and execute a training programme for GCP Inspectors to provide guidance on the practical inspection techniques and to facilitate the conduct of certain aspects of GCP inspections in a harmonised manner.
• Establish a network of experts in technical topics covering GCP and increase understanding of relevant topics of interest:
  • Support Working Group activities related to Data Governance -aimed at providing inspectors with knowledge, tools and training to inspect electronic systems and digital health technologies as well as addressing future challenges posed by emerging tools and technologies.
  • Support Working Group activities related to Risk Adapted Approaches in clinical trials -aimed at providing inspectors with knowledge and tools to understand and inspect risk proportionate approaches used in clinical trials.
• Develop a communication system between PIC/S Participating Authorities to facilitate discussions related to GCP:
  • Promote and support participation in the PIC/S Joint Visit Programme, including sharing learning and experiences amongst inspectors.
  • Provide networking opportunities amongst inspectorates from different agencies.
• Coordinate PIC/S input to international guidelines as needed (e.g., ICH/vICH related to GCP inspections. A recent example of this is participation as an observer on the ICH E6 R3 Expert Working Group.). Develop and maintain a common approach and intepretation of the international guidelines (e.g., ICH/vICH, CIOMS).

Upcoming Expert Circle Meetings and Training Activities

Expert Circle meeting on 4-5 November 2025

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Active JVP Groups in the field of GCP

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