Geneva, 14 October 2022: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin (Ireland) on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium titled “Thriving at 50 and Striving Forward” aimed at promoting and highlighting PIC/S’ contributions to international collaboration and co-operation while being resolutely turned towards the future.
The symposium was opened by Ireland’s Health Products Regulatory Authority (HPRA) Chief Executive, Ms Lorraine Nolan, who was hosting. The PIC/S Chairperson, Mr Paul Gustafson (Health Canada) presented on PIC/S new strategic plan for 2023-2027 while the PIC/S Deputy Chairperson, Ms Susan Laska (US FDA), outlined the evolution of pharma industry and PIC/S. The keynote speaker, Ms. Emer Cooke, Executive Director of the European Medicines Agency (EMA), addressed how to strive for better international relationships and collaboration. The programme comprised a wide range of presentations and panel discussions on inspection-related topics, which included participation from Heads of Medicines Agencies, Heads of GMDP Inspectorates and official PIC/S representatives.
Close to 200 participants from all continents participated in the event, including most of PIC/S 54 Participating Authorities and 7 (Pre-)Applicant Authorities, PIC/S Associated Partner Organisations (European Commission, EDQM, EMA, UNICEF, WHO and WOAH) as well as a number of non-PIC/S Competent Authorities. The anniversary also provided a unique opportunity to meet and engage with a range of invited stakeholders present for the occasion and to reconnect with the wider PIC/S network. A more detailed press release will follow covering also PIC/S meetings and 2022 Annual Training Seminar, which took place in Dublin back-to-back with the anniversary symposium.
> To the new PIC/S Strategic Plan (2023-2027)
> To the Anniversary Programme
> To the Anniversary Group Photo
> To the Anniversary Promotional Video
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.
Geneva, 23 January 2024:
Friday, 19 January marked the inaugural kickoff meeting of the PIC/S-EMA-WHO Joint Implementation Working Group, bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The goal is to achieve harmonized interpretation of the newly released PIC/S-EU GMP Annex 1 on Sterile Manufacturing. Follow us on LinkedIn.