Geneva, 15 July 2021: PIC/S is pleased to announce the coming into force on 15 July 2021 of the PIC/S Recommendation document titled “How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management”, PI 054-1. This document addresses two fundamental and inter-related elements of the PIC/S GMP Guide - PQS effectiveness and the management of changes. It provides practical guidance for GMP Inspectors in these areas, and the implementation of that guidance has the potential to ultimately lead to the more timely management of risks to product quality and patient safety, as well as better quality and manufacturing performance, continual improvement and innovation. This serves the interest of patients and animals.
In addition to providing guidance for GMP Inspectors, the document provides the pharmaceutical industry with a ready-made solution for addressing a key aspect of ICH Q12 - the requirement to have an effective PQS that can support the risk-based management of post-approval changes when there is more flexible regulatory oversight of such changes in place.
The input of industry representatives was considered during the development of this document and their contributions are gratefully acknowledged.
To download this guidance (PI 054-1), please consult the page “Publications”.
Geneva, 13 December 2024: PIC/S has published the following two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment, led by Jenny Hantzinikolas (Australia / TGA), and will enter into force on 1 January 2025. They are available for downloading on the page "Publications".
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.
MoreThis 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.
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.