Member of the British Pharmacopoeia CommissionClosed
|Body:||British Pharmacopoeia Commission (BPC)|
|Appointing Department:||Department of Health|
|Number of Vacancies:||6|
|Remuneration:||Members are entitled to claim a fee of £325 per meeting (preparation and attendance)|
|Time Requirements:||Three meetings per year (March, July and November).|
Closed for Applications
04/10/2019 at 12:00
Final Interview Date
Professor Sir Michael Rawlins Added 09/09/2019
Chair of the MHRA • Representative of Organisation
Professor Kevin Taylor Added 09/09/2019
Chair of BPC • Departmental Official
James Pound Added 09/09/2019
Secretary & Scientific Director (BPC) • Representative of Organisation
Political Activity - Notes -
Cindy Butts Added 09/09/2019
Commissioner, Criminal Cases Review Commission • Independent Member
Ministers are seeking to make 6 appointments to the board of British Pharmacopoeia Commission.
Role and Responsibilities of a Member
The British Pharmacopoeia Commission (BPC) was established under Section 4 of the Medicines Act 1968 (superseded by the Human Medicines Regulations 2012). It is responsible for preparing new editions of the British Pharmacopoeia and British Pharmacopoeia (Veterinary) and for keeping them up to date. It also provides advice to the United Kingdom delegation to the European Pharmacopoeia Commission, of which the United Kingdom is a member. The BPC is also responsible for selecting and devising British Approved Names.
The British Pharmacopoeia contributes to the overall control of the quality of medicinal products by providing an authoritative statement of the quality that a product is expected to meet at any time during its period of use. The publicly available and legally enforceable pharmacopoeial standards are designed to complement and assist the licensing and inspection processes and are part of the system for safeguarding purchasers and users of medicinal products.
The BPC is an Advisory Non-Departmental Public Body and is part of the Medicines and Healthcare products Regulatory Agency.
Terms of Reference
Under the terms of the Human Medicines Regulations 2012, the duties of the BPC are to:
- Prepare new editions of the British Pharmacopoeia and related publications (The British Pharmacopoeia (Veterinary) and British Approved Names);
- Prepare a list of names to be used as the title of monographs in the British Pharmacopoeia and related publications;
- Prepare amendments to the British Pharmacopoeia and related publications.
In addition, the duties of the BPC are to:
- Frame clear and unequivocal technical advice to discharge the Commission’s responsibilities both for the British Pharmacopoeia, the British Pharmacopoeia (Veterinary) and British Approved Names and as the national pharmacopoeial authority with respect to the European Pharmacopoeia;
- Provide clear advice to support the development of clear policies for the preparation and publication of the British Pharmacopoeia and its related publications;
- Act as Chair, Vice-Chair or member of one or more Expert Advisory Groups or Panels of Experts of the BPC;
- Approve new and revised monographs and supporting material for inclusion in new editions of the British Pharmacopoeia, the British Pharmacopoeia (Veterinary) and British Approved Names.
To be considered, you must be able to demonstrate that you have the qualities, skills and experience to meet all the essential criteria for appointment.
For all the roles, you must:
- Be able and prepared to contribute actively to the work of the BPC
- Be able to assimilate complex information at pace
- Be a skilled communicator
You must also:
- Have a general understanding of the purpose and function of a pharmacopoeia and its place in the overall regulatory system (UK and Europe)
- Have significant experience in the pharmaceutical industry, academia or the hospital service, including in one or more of the following areas:
- Quality control of medicinal products (three posts)
- Analysis of biological and biotechnology products, ideally with expertise in the area of advanced therapy medicinal products and/or biotechnologically produced proteins (one post)
- Unlicensed medicines (one post)
- Veterinary medicine (one post)
Be recognised by their peers as an eminent member of their profession, with wide and recent experience in at least one of the following areas:
- The practice of pharmacy
- Analytical chemistry
- Standardisation and specifications for human medicines
- Standardisation and specifications for veterinary medicines
- Standardisation and specifications for biological medicines.
You may demonstrate first-hand experience of the work of one or more of the BPC Expert Advisory Groups or Panels of Experts.
British Pharmacopoeia Commission role and responsibilities
The British Pharmacopoeia Commission was established in 1970 under Section 4 of the Medicines Act 1968 (superseded by the Human Medicines Regulations 2012). It is an Advisory Non-Departmental Public Body, sponsored by the Department of Health and Social Care. As such, it has no staff but is supported by a Secretariat from the Medicines and Healthcare product Regulatory Agency. A triennial review was carried out in 2014, which confirmed that the BPC performs necessary functions and should continue to operate as an ANDPB.
The key role of the BPC is the preparation of the annual editions of the British Pharmacopoeia (BP), which is widely recognised as one of the leading global pharmacopoeias. The publicly available and legally enforceable pharmacopoeial standards are designed to complement and assist the licensing and inspection processes and are part of the system for safeguarding purchasers and users of medicinal products.
The BPC has responded to the changing pharmaceutical environment, to changes in priority for the European Pharmacopoeia Commission and to the changes taking place within the MHRA to ensure that the agency is fit for the future. This includes supporting innovation and ensuring the safe production and supply of medicines. Current strategic priorities for the BPC include the development of appropriate standards for biological medicines, the development and application of a revised policy on dissolution testing and the potential application of Analytical Quality by Design principles to the development of national monographs. The BPC plays a significant role in the work of the European Pharmacopoeia, contributing to the development of policies and monographs for that pharmacopoeia, and works closely with other national and international pharmacopoeias. It has strong links with the pharmaceutical industry, with academia and with the National Institute of Biological Standards and Control.
Members of the BPC also serve on the Expert Advisory Groups and Panels of Experts responsible for developing national monographs, thereby ensuring that the strategic priorities of the BP Commission are implemented within these groups.
An annual report, highlighting the work of the BPC, is published each year (https://www.gov.uk/government/publications/human-medicines-regulations-2012-advisory-bodies-annual-report-2018).
For further information, see the BP website (https://www.pharmacopoeia.com/the-bp-Commission.
All members must comply with the British Pharmacopoeia Commission Code of Practice on Declaring Interests in the Pharmaceutical Industry (https://www.pharmacopoeia.com/file/BPC-Code-of-Practice.pdf) and must complete an annual declaration of interests form. All members will be subject to an annual appraisal.
Message from Prof Kevin Taylor, Chair, British Pharmacopoeia Commission.
“The British Pharmacopoeia, which produces legally enforceable quality standards for medicinal products, plays a vital role in the regulatory framework that ensures medicines supplied and used in the UK are safe and efficacious.
As Chair it is a real pleasure and privilege to work with members of the BP Commission and its expert groups, the BP Secretariat and laboratory staff, and external stakeholders including industry, to develop meaningful documentary standards which have a direct impact on public health.
With more than 150 years of history, the BP has a strong international presence and an enviable reputation for accessibility, excellence and engagement with external stakeholders. I am very keen that the BP maintains its international pre-eminence whilst continuing to develop and innovate, embracing the latest science, and where appropriate exploring alternative approaches to analytical methods and standards to support innovation and to ensure the quality of all medicines, including biological products.”
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