News

June 2018

New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities

Geneva, 14 June 2017: PIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.

This guidance provides a tool and framework which aims to help Competent Authorities (CA) prioritise resources for GMP inspections for human and veterinary medicines. The main feature of the guidance is that it outlines a process for desk-top assessment of GMP compliance of overseas facilities to identify instances where an acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs without the need for an on-site inspection.

The guidance is based on a draft by the International Coalition of Medicines Regulatory Authorities (ICMRA) GMP Inspection Reliance Framework. It is a non-binding (i.e. applicable on a voluntary basis) high-level guidance for ICMRA and PIC/S Participating Authorities (PA) alike.

For more information see the PIC/S Newsletter of May 2018

To download the guidance, please consult the page “Publications” or click on the link below:

November 2024

Strengthening regulatory inspection standards to facilitate improved access to quality medicines in Africa

Geneva, 20 November 2024: PIC/S is pleased to announce that in May 2024 it has been awarded a 3-year grant from the Bill & Melinda Gates Foundation.

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This funding will provide PIC/S with the necessary resources to further its mission to improve public health by leading development and implementation of inspection frameworks for human and veterinary medicines through harmonisation of standards and offering world class training to regulatory inspectors around the globe.

The PIC/S project workstreams supported by this grant will aim at strengthening regulatory inspection standards to facilitate improved access to quality medicines in African countries by preparing a number of African National Regulatory Authorities for entry into PIC/S - through the PIC/S pre-accession process - as well as foster exchanges and co-operation between PIC/S, the upcoming African Medicines Agency (AMA) and its related members.

PIC/S looks forward to the possibilities that this grant will bring and to the impact it will have globally thanks to the support of the Bill & Melinda Gates Foundation.

July 2024

2024 PIC/S Seminar (Brasilia, Brazil)

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).

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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.

June 2024

Recruitment of New PIC/S Secretary / Executive Director

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

  • Advanced university degree is required. Additional diploma are a plus.
  • Professional experience in working for a national or international organisation for at least 10 years (of which at least 5 at managerial level).
  • Experience with human and financial resource management, complex projects management, negotiations, and international policy processes.
  • Fluency in written and spoken English with good communication skills. Knowledge of other languages, in particular French, is a further asset.
  • Swiss, EU/EEA or UK citizenship

 

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.

June 2024

Zimbabwe applies for PIC/S pre-accession

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.

April 2024

JAPAN / PMDA collaboration with PIC/S and WHO

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).