This training event is organised within the frame of the EU Joint Action EU4H 11, which aims at strengthening capacities of EEA GMP/GDP inspectorates. It will be hosted by France / ANSM, which is leading “Work Package 5 on Training and Qualification of Auditors”. This training is for auditors operating in the frameworks of the EEA Joint Audit Programme (JAP) and the PIC/S Joint Reassessment Programme (JRP). It will take place virtually on 5-6 October 2023. The JAP and JRP programmes regularly audit the Quality Systems of GMP Inspectorates from PIC/S Participating Authorities, respectively EEA Authorities. The training will focus on the main topics which are necessary to carry out a JAP or JRP audit.
This virtual training event is open only to PIC/S Participating Authorities and/or EU/EEA Authorities.
The 53rd PIC/S Committee Meeting will take place in Bangkok (Thailand) on 6-7 November 2023 (beginning at 2 p.m. on the first day and finishing at 6 p.m. on the second day). PIC/S Committee Meetings are only open to Committee representatives of PIC/S Participating Authorities, PIC/S Applicants and Pre-Applicants, PIC/S Partners and invited Guests.
The PIC/S Committee Meeting will be preceded by a Meeting of the PIC/S Executive Bureau on 6 November 2023 (morning). The PIC/S Executive Bureau Meeting is only open to PIC/S Executive Bureau Members and invited Guests.
Thailand's Food and Drug Administration (Thai FDA) is pleased to host the 2023 PIC/S Seminar on “Soft Skills that Make a Good GMP/GDP Inspector in 2023” in Bangkok (Thailand) from 8-10 November 2023, 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 52nd PIC/S Committee Meeting will take place in Geneva (Switzerland) on 11-12 May 2023 (beginning at 2 p.m. on the first day and finishing at 5 p.m. on the second day). PIC/S Committee Meetings are only open to Committee representatives of PIC/S Participating Authorities, PIC/S Applicants and Pre-Applicants, PIC/S Partners and invited Guests.
The PIC/S Committee Meeting will be preceded by a Meeting of the PIC/S Executive Bureau on 11 May 2023 (morning). The PIC/S Executive Bureau Meeting is only open to PIC/S Executive Bureau Members and invited Guests.
PIC/S, the European Commission / EMA and WHO have developed a dedicated webpage for Inspectors on the PIC/S Inspectorates’ Academy (PIA) highlighting changes to Annex 1 of the PIC/S - EU GMP Guide. It includes a series of short videos by the Chair of the Joint Working Group on Annex 1 explaining the main differences introduced by the revision, as well as a short survey. This is the first stage of a common training plan for Inspectors on revised Annex 1.
This webpage is open to Regulatory Authorities only i.e. PIC/S Participating Authorities, Partners, (Pre-)Applicants and non-PIC/S Member Medicines Regulatory Authorities part of European Union Member States or WHO Member States.
MoreThe Austrian Agency for Health and Food Safety (AGES) is pleased to host virtually the 26th PIC/S Expert Circle Meeting on Human Blood, Tissues, Cells and Advanced Therapy Medicines Products (ATMPs) and Webinar on the new Annex 2A (on ATMPs) of the PIC/S GMP Guide from 14-16 March 2023. These virtual events will consist in a mixture of presentations and workshops. They are open to Regulatory Inspectors in the field of blood, tissues, cells and ATMPs from PIC/S Participating Authorities, Partners, (Pre-)Applicants and Non-Member Medicines Regulatory Authorities.