The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom, is pleased to host the First Hybrid PIC/S Expert Circle Meeting on Good Pharmacovigilance Practices (GVP) and Good Clinical Practices (GCP), which will be held in London, as well as remotely, on 4-5 November 2025.
On day 1, the meeting will focus on discussions amongst experts and provide training so that GVP inspectors will be able to obtain the required knowledge and competence to inspect key topics in a harmonised manner related to emerging technologies such as artificial intelligence and machine learning (AI-ML). Day 2 will be dedicated to facilitate expert discussions and deliver focused training to ensure that GCP inspectors acquire the knowledge and competence to inspect clinical trials in accordance with the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use Harmonised Guideline for Good Clinical Practice (E6 R3).
Inspectors will have the option to attend both GVP and GCP trainings, or to just select one depending on their area(s) of interest.
The meeting is open to GVP and GCP inspectors from PIC/S Members, (Pre-)Applicants, Partners and Non-Member Regulatory Authorities.
To register, please follow https://mhrapics.co.uk/home
(a registration fee will apply).
The Department of Health and the Pharmacy and Poisons Board of Hong Kong are pleased to host the 2025 PIC/S Seminar on “Advanced technologies in pharmaceutical manufacturing” in Hong Kong (SAR) from 5-7 November 2025, preceded by the PIC/S Committee meeting.
The Seminar is the main annual international training event by PIC/S which is open to GMP Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and non-PIC/S Member Medicines Regulatory Authorities.
For more information, please contact the PIC/S Secretariat
The PIC/S Working Group on Training Material for ICH Q12 is pleased to invite GMP Inspectors and Assessors of PIC/S PAs to a Webinar focused on Q12 implementation. It will be held virtually on 6 October 2025.
The main objectives are to increase Inspectors’ and Assessors’ understanding of Q12 and its implications, provide insights into industry implementation, share practical experiences, promote a harmonized approach to the Guidance, support the development of tools for Inspectors, and increase awareness and use of PI-054.
The Webinar is open to PIC/S Participating Authorities only. For information on registration, please contact the PIC/S Secretariat.
UNICEF is pleased to host the 8th PIC/S Expert Circle meeting on Good Distribution Practice (GDP), which will be held in Copenhagen, Denmark, on 23-25 September 2025.
The meeting will focus on latest developments in the field of "Good Distribution Practice" and will consist of presentations, interactive workshops, panel sessions, and discussions.
The meeting is open to Inspectors of PIC/S Members, (Pre-)Applicants and Partners.
This Seminar is organised by Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), with the support of PIC/S and WHO. It will take place on 17-19 September 2025. The focus of the Seminar is on advanced technologies in pharmaceutical manufacturing and regulatory reliance.
The seminar will bring together GMP inspectors from Asia and other regions to discuss recent developments, exchange practical experiences, and promote regulatory convergence in GMP inspections. The event will include presentations, panel discussions, and interactive sessions featuring speakers from international regulatory authorities and organisations.
For more information see flyer.