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.
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The 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.