Geneva, 20 June 2018: the following Chapters and Annex of the PIC/S GMP Guide have been revised:
The revised Chapters 3, 5 & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management. Chapter 3 and 5 have been revised to include requirements to prevent cross-contamination. A change in the qualification of suppliers has also been introduced by revised Chapter 5. Expectations with regard to quality management system for the evaluation of quality defects in relation to product recalls have been expanded in Chapter 8, which has been entirely revised. Revised Annex 17 has been aligned with the EU revision of Annex 17 which will be published shortly by the European Commission (EC).
The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada / RORB). The revised GMP Guide (PE 009-14) will enter into force on 1 July 2018. All non-EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.
To download the revised GMP Guide (PE 009-14), please consult the page “Publications”
Geneva, 16 July 2024: Registrations for the 2024 PIC/S Seminar on "Annex I Unveiled: Shaping the Future of Sterility” (Brasilia, 6-8 November 2024) are now open (for Medicines Regulatory Authorities only).
MoreThe 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.
Geneva, 24 June 2024:
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an organisation between currently 56 health regulatory authorities from all over the world, which has the status of a not-for-profit Association under the Swiss law. Its secretariat is based in Geneva (Switzerland).
PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of Good Manufacturing Practice (GMP) and by offering word-class training to regulatory inspectors. It also facilitates co-operation and networking between competent authorities, regional and international organisations. For more information, see www.picscheme.org
To lead the PIC/S Secretariat, the PIC/S Executive Bureau, has been mandated to recruit a new EXECUTIVE DIRECTOR
Main responsibilities
The statutory position of the Executive Director is that of “PIC/S Secretary”. He/she reports directly to the PIC/S Chairperson, whom he/she is assisting in his/her mandate. The full job description is available at the following link: https://picscheme.org/en/publications
In summary, the Executive Director is responsible for the overall delivery of secretariat services to the PIC/S Committee and other PIC/S bodies, which report to the Committee. The Executive Director contributes to (i) the elaboration of PIC/S overall strategies and policies and (ii) the general co-ordination, planning and supervision of PIC/S activities. He/she provides policy analysis and leadership in developing and implementing, amongst others, innovative management approaches, communication strategies, project management, and work programmes. He/she is also responsible for PIC/S finances and the preparation and implementation of the PIC/S budget.
The Executive Director acts as Secretary to the PIC/S Executive Bureau (EB), of which he/she a non-elected Member, with no voting right. He/she works closely with the EB to ensure the smooth running of activities and the successful development and expansion of PIC/S. He/she represents PIC/S externally upon request of the EB.
The Executive Director is the head of the PIC/S Secretariat, in charge of directing and managing the Secretariat’s human, financial and other resources (e.g. IT) in line with the relevant rules and procedures (in particular Staff Agreement and Financial Rules).
Profile
For the full list of requirements, see job description.
Start of contract / employment
January 2025
Job location
Geneva, Switzerland
Employment conditions
Full-time employment (100%)
Gross annual salary of CHF 185,000 (excl. bonus & benefits, see below)
Attractive working conditions (6 weeks holidays, flexible working hours, remote working, contribution to health insurance, child allowance, bonus, etc.)
Application process
Please send a motivation letter and CV to Marina.Ditesheim@picscheme.org by 31 July 2024 by mentioning “Application to PIC/S Secretary” in the subject line”.
You will be notified of the receipt of your application by the outsourced recruitment agent. Short listed applicants will be contacted regarding the next steps of the selection process.
As an equal opportunity employer, PIC/S welcomes applications from all suitably qualified candidates, irrespective of sex, gender, sexual orientation, marital or parental status, ethnic or social origin, disability, religion, or belief.
Geneva, 6 June 2024:
On 20 October 2023, the Medicines Control Authority of Zimbabwe (MCAZ) applied for PIC/S pre-accession. The pre-accession application was considered complete on 6 December 2023. The Rapporteur is in the process of being appointed by written procedure.
Geneva, 10 April 2024:
At its meetings of May and November 2023, the PIC/S Committee welcomed the announcement made by Japan / PMDA that it would second one PMDA expert to the PIC/S Secretariat in Geneva (Switzerland).
Since 1 April 2024, Dr SUZUKI Hirofumi, PMDA, has been seconded to the PIC/S Secretariat where he is going to serve in order to facilitate PIC/S Secretariat activities including collaboration with the World Health Organization (WHO) with a view to strengthen regulatory capacity building in the Asian region (for more information, see link)
Dr SUZUKI will support the PIC/S Secretariat regarding the harmonisation of GMP standards and the training of inspectors for PIC/S Participating Authorities, especially in Asia. Dr SUZUKI has several years of experience in various PIC/S bodies as well as in participating in PIC/S on-site assessment visits. He will help supporting the operation of PIC/S activities with a focus on Asia.
PMDA has been a Member of PIC/S since 2014. This secondment represents an innovative way by PMDA to support PIC/S and it will help strengthen the PIC/S Secretariat in line with PIC/S’ Strategic Plan (2023-27).
Geneva, 30 January 2024:
The Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) hosted the 6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) from 29 November to 1 December 2023 via Zoom. A total of 230 participants joined the meeting. The meeting included discussions on contemporary issues and latest developments in the field of GDP and supply chain integrity; consolidating lessons learnt during COVID to support uninterrupted supply chain of medicine; sharing experiences between inspectors to improve consistency among inspectors in the field of GDP; and exchanging ideas and fostering collaboration among inspectorates. Follow us on LinkedIn.