Frequently Asked Questions: USP Council of Experts and USP Expert Committees
- What is the USP Council of Experts?
- What are USP Expert Committees?
- What are USP Expert Panels?
- What are the responsibilities of the members of the Council of Experts and its Expert Committee?
- How much time does an Expert Committee member spend on USP activities?
- What expertise is required?
- What is the nomination and election process for the Council of Experts members (Expert Committee chairs) and Expert Committee members?
- What is the term of service for members of the Council of Experts and Expert Committees?
- What is the term of service for Expert Panel members?
- What are USP's conflict of interest and confidentiality policies?
- How much travel is required from an Expert Volunteer?
- What is the general make-up of an Expert Committee?
- What is the decision-making process for Expert Committees?
- How do Expert Panels advise Expert Committees?
- What type of staff support is provided to Expert Committees and Expert Panels?
- Do I need a computer to serve as an Expert Volunteer?
The USP Council of Experts and its Expert Committees are the scientific decision-making body of USP. Members of the Council of Experts are elected by the USP Convention membership at its every-five-year meeting and serve as chairs of USP Expert Committees.
Expert Committees address specific standards-setting areas within USP such as Chemical Medicines, Biologics and Biotechnology, General Chapters, and others. Expert Committee members are elected by the Council of Experts.
Expert Panels are formed to provide additional expertise on a particular compendial topic, thereby supplementing Expert Committee expertise. Expert Panels are intended to provide flexibility and scalability into USP’s standards-setting activities, and help ensure that USP standards are based on the best scientific knowledge available. They are advisory to one or more Expert Committees; they are not decision-making bodies.
An Expert Panel, when formed, will have a specific charge (including scope of work, deliverables, and timeline for completion), and will be dissolved at the conclusion of its work. As such, USP calls for Expert Panel candidates as the need for such bodies arises.
The USP Council of Experts and its Expert Committees are responsible for developing and revising standards for medicines and foods that appear in the United States Pharmacopeia and the National Formulary (USP–NF), the Food Chemicals Codex, the Dietary Supplements Compendium, USP Compounding Compendium, and the Herbal Medicines Compendium. Members of the Council of Experts and its Expert Committee develop and review monographs, general chapters, testing methods, and reference materials, and collaborate on scientific topics supporting the standards that appear in USP’s compendia.
The average Expert Committee member spends approximately 3.5 hours per week on USP activities. Expert Committees generally meet face-to-face at a USP site with teleconference/web meetings as required. USP sites include its USP–U.S. in Rockville, Maryland; USP–Switzerland in Basel; USP–India in Hyderabad; USP–China in Shanghai; USP–Brazil in Sao Paulo; USP–Ghana in Accra; and USP–Ethiopia in Addis Ababa.
While each Expert Committee requires specific expertise in either analytical chemistry, analytical biochemistry, measurement science, food and dietary supplement science, or other applied sciences, candidates should have advanced degrees (doctoral degrees or the equivalent based on extensive experience), and should be actively working in related scientific and/or regulatory disciplines. A complete list of expertise sought is included in the overview of (Expert Committees)
The USP Nominating Committee for the Council of Experts will nominate two qualified candidates to stand for election as chair of each Expert Committee at the April 2015 USP Convention. Those candidates elected by the USP Convention Membership will serve as chairs of the Expert Committees and members of the Council of Experts. The Council of Experts will elect Expert Committee members.
The term of service is five years.
Expert Panel terms vary, from 12 months to the full five-year term or longer.
Maintaining independence and impartiality is critical to the integrity and credibility of USP’s standard-setting activities. Members of the Council of Experts and its Expert Committees must remain free of actual or perceived conflicts of interest in the performance of their duties for USP. Members of the Council of Experts and its Expert Committees are required to submit and keep updated statements disclosing interests that may create conflicts. Members of Expert Panels are also required to disclose any conflicts that may arise, although Expert Panel members may represent interests such as their employer. USP also has a confidentiality policy to protect those who submit confidential material to USP in support of USP standards development. Expert Committee members must enter into a mandatory signed agreement to maintain the confidentiality of all information gained in the course of his or her USP activities. Information obtained at USP may not be used or disclosed for any purpose, unless already publicly available.
Most Expert Committees meet at USP–U.S. in Rockville, Maryland, once or twice per year. The cost of travel to USP meetings typically is covered by USP.
The membership of each USP Expert Committee varies according to its responsibilities. USP strives for a balance of industry (including from innovator, generic, and over-the-counter company, laboratory, etc.), academia, health care practitioner, regulatory, and independent experts to comprise its Expert Committees, but will seek the most qualified volunteer experts regardless of organizational affiliation. USP also strives for a mix of U.S. and international experts to reflect the global use of USP’s standards.
USP creates and continuously revises standards through a unique public–private collaborative process, which involves interested industry stakeholders, the government, and other interested parties from anywhere in the world. The standards may originate from pharmaceutical manufacturers or other sponsors or from USP’s own laboratory network. USP's scientific staff and volunteer experts review this material, conduct additional laboratory tests as necessary, and ensure that the information is subject to a process of public review and comment. The public process helps to refine and finalize this information for publication in the USP–NF, FCC, or other USP compendium. USP Expert Committees make the final decisions to approve and publish the standards.
Expert Panels are formed solely to advise one or more Expert Committee on scientific and technical matters for which the Expert Committee does not have sufficient expertise. Expert Panels usually meet and address the issues, then form recommendations to the Expert Committee. The Expert Committee has final decisional authority on any recommendation of an Expert Panel.
Each Expert Committee and Expert Panel is overseen by a member of USP’s senior scientific staff, usually within the Global Science and Standards Division, under the leadership of the Chief Science Officer, and Global Alliances and Organizational Affairs, which includes the Healthcare Quality Standards group and Executive Secretariat functions. Support for Expert Committees includes a Scientific Liaison, Reference Standards Scientist, and an Expert Committee Manager.
All Council of Expert, Expert Committee and Expert Panel members must have access to a computer and the Internet in order to serve as a USP Expert Volunteer.
Ask USP: send questions to USPVolunteers@usp.org.