Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) is pleased to host the 27th PIC/S Expert Circle on Human Blood, Tissues, Cells and ATMPs on 20-22 August 2024 in Kuala Lumpur (Malaysia).
The focus of this meeting will be on “Human Blood, Tissues, Cells and ATMPs: Inspection Approach, Current Trends and Experience Sharing” and will consist of presentations and workshops.
The meeting is open to Inspectors of PIC/S Participating Authorities, PIC/S Applicants and Pre-Applicants, PIC/S Partners and other interested non-PIC/S Regulatory Authorities in the field of human blood, tissues, and cells (including ATMPs).
The Malta Medicines Authority (MMA) is pleased to host the 7th PIC/S Expert Circle meeting on Good Distribution Practice (GDP), which will be held in Malta on 24-26 September 2024.
The focus of this meeting will be on "Good Distribution Practice and Supply Chain Integrity" and will consist of presentations, interactive workshops, panel sessions, and discussions.
The meeting is open to Inspectors of PIC/S Members-only.
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
The National Health Surveillance Agency (ANVISA) is pleased to host the 2024 PIC/S Seminar on “New Annex I of Sterile Products” 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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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 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.
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 6-7 February 2024. The focus of the Webinar is on GMP regulations, pharmaceutical quality issues, case study on GMP inspection etc.
The Webinar is open to employees of Regulatory Authorities only (beginner to intermediate level). It is not open to the industry or non-Regulatory Authorities.
The Pharmacy and Poisons Board of Hong Kong (PPBHK), Hong Kong SAR, China, is pleased to host virtually the 6th PIC/S Expert Circle on Good Distribution Practices (GDP) between 29 November and 1 December 2023. The focus of this meeting is to provide training to GDP Inspectors on Good Distribution Practice and Supply Chain Integrity. It will consist of presentations, interactive workshops and discussions. The meeting is open to PIC/S Participating Authorities, Partners, (Pre) Applicants and non-Member Medicines Regulatory Authorities.
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.