PIC/S Meetings and Training Events

2022

29 November - 2 December 2022

PIC/S Expert Circle on Quality Risk Management (QRM) Advanced Training Event and Meeting in Sao Paulo (Brazil)

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.

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Past events

22 - 23 March 2022

Joint European Commission - EMA - PIC/S Virtual Training for Auditors

This training event is organised jointly by the European Commission, the EMA and PIC/S 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 22-23 March 2022. 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.

2 March 2022

PIC/S Expert Circle on Quality Risk Management (QRM) Webinar Training Event and Meeting

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is pleased to host a Webinar for the next PIC/S Expert Circle on Quality Risk Management (QRM) Training Event and Meeting on 2 March 2022.

The meeting will review recent and ongoing initiatives of the Expert Circle, as well as wider work on Quality Risk Management being led by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The Webinar is open to Regulatory Authorities-only i.e. PIC/S Participating Authorities, Partners, (Pre)Applicants and non-PIC/S Member Medicines Regulatory Authorities. Deadline for registration is 16 February 2022.

For more information, please contact the PIC/S Secretariat.

14 - 15 December 2021

PIC/S Expert Circle on Cross-Contamination in Shared Facilities (CCCISF) Webinar Meeting

The Inspection Services of the Prequalification Unit, World Health Organization (WHO)  is pleased to host the second PIC/S Expert Circle on Cross-Contamination in Shared Facilities (CCCISF) meeting to be held virtually, on 14-15 December 2021.

The meeting is designed to share and develop an understanding of challenges facing Inspectors on inspection of risk of (chemical) Cross-Contamination in Shared Facilities and the inspection approaches required to successfully inspect for compliance with PIC/S GMP. A number of specific topics will be addressed. The Expert Circle meeting is open to PIC/S Participating Authorities, Partners, (Pre)-Applicants and Non-Member Medicines Regulatory Authorities. Deadline for registration has been extended to 26 November 2021.

For more information, please contact the PIC/S Secretariat.