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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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 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.
Brazil’s National Health Surveillance Agency (ANVISA) is pleased to host the next PIC/S Expert Circle on Quality Risk Management (QRM) Advanced Training Event and Meeting on 29 November - 2 December 2022 in Sao Paulo (Brazil).
The 3-day training event is designed to address how to critically inspect the implementation and use of QRM during regulatory inspections; how to critically inspect Risk Assessments at manufacturing sites at an advanced level; and how to use the PIC/S Recommendation on Risk-Based Inspection Planning in the GMP Environment (PI 037-1). It will be followed by a 1-day Expert Circle meeting on its future activities.
Both the training event and meeting are open to PIC/S Participating Authorities, Partners, (Pre-)Applicants and Non-Member Medicines Regulatory Authorities.
This Webinar is organised by Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), with the support of PIC/S. It will take place on 25-26 October 2022. The focus of the Webinar is on Data Integrity (DI) with the aim to allow to learn basics of DI and to utilize the knowledge learned from the Webinar to enhance the regulatory system in the participants’ own organization.
The Webinar is open to employees of Regulatory Authorities with working experience of GMP inspection. It is not open to the industry or non-Regulatory Authorities.