The European Medicines Agency (EMA) is pleased to host a QRM Training Event by the PIC/S Expert Circle on Quality Risk Management (QRM) on 28-30 January 2025.
The Training Event will provide training to GMP Inspectors on the 2023 revisions to the ICH Q9 guideline on Quality Risk Management. The revised guideline, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in January 2023, is known as ICH Q9(R1).
The Training event will be face-to-face (with possibility of remote attendance for plenary sessions). It is open to Regulatory Authorities-only i.e. PIC/S Participating Authorities, Partners, (Pre)Applicants and non-PIC/S Member Medicines Regulatory Authorities.
For more information, please contact the PIC/S Secretariat.
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The 56th PIC/S Committee Meeting will take place in Geneva (Switzerland) on 14-15 April 2025 (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 14 April 2025 (morning). The PIC/S Executive Bureau Meeting is only open to PIC/S Executive Bureau Members and invited Guests
The 57th PIC/S Committee Meeting will take place in Hong Kong (SAR) on 3-4 November 2025 (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 3 November 2025 (morning). The PIC/S Executive Bureau Meeting is only open to PIC/S Executive Bureau Members and invited Guests.
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 55th PIC/S Committee Meeting will take place in Brasilia (Brazil) on 4-5 November 2024 (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 4 November 2024 (morning). The PIC/S Executive Bureau Meeting is only open to PIC/S Executive Bureau Members and invited Guests.
The National Health Surveillance Agency (ANVISA) is pleased to host the 2024 PIC/S Seminar on "Annex I Unveiled: Shaping the Future of Sterility” in Brasilia (Brazil) from 6-8 November 2024, 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.
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This Seminar 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 8-10 October 2024. The focus of the Seminar is on GMP regulation in Japan, group work on on-site GMP inspection, group work on document-based GMP inspection, and manufacture's efforts on pharmaceutical quality issues.
The Seminar is open to employees of Regulatory Authorities only (beginner to intermediate level). It is not open to the industry or non-Regulatory Authorities. Deadline for registration is 9 July 2024.
For more information see flyer