The PIC/S Expert Circle on Good Pharmacovigilance Practices (GPV) was established in 2023. The GPV Expert Circle organizational structure and mandate were finalized to include: 1) GPV Best Practices Working Group, established to facilitate discussion and the exchange of information among inspectors to support training and harmonization; 2) Artificial Intelligence-Machine Learning (AI-ML) Working Group, 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 key topics related to AI-ML in pharmacovigilance; 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.
Chairperson of PIC/S Expert Circle on GPV: Sherry Bous (US FDA)
The goals of the Expert Circle on GPV are to:
1. Design, develop and execute a training programme for GPV Inspectors to provide guidance on the practical inspection techniques and to facilitate the conduct of certain aspects of GPV inspections in a harmonised manner.
2. Establish a network of experts in technical topics covering GPV and increase understanding of relevant topics of interest:
3. Develop a communication system between PIC/S Participating Authorities to facilitate discussions related to GPV:
4. Coordinate PIC/S inputto international guidelines as needed (e.g., ICH/vICH and CIOMS guidelines related to GPV inspections). Develop and maintain a common approach and intepretation of the international guidelines (e.g., ICH/vICH, CIOMS).
2025 (date to be announced)
Inspectors interested in joining a JVP group in the field of GPV are invited to contact the Secretariat, which will provide an application form and co-ordinate the establishment of a new JVP group.