USP and the British Pharmacopoeia Commission Collaborate on Newly Proposed Standards: http://uspgo.to/JC5LMr
Rules & Procedures of the 2010–2015 Council of Experts
9. Advisory Stakeholder Forums & Project Teams
9.01 Formation
Stakeholder Forums and Project Teams may be formed by the CoE Chairperson.
9.02 General
- Membership. Stakeholder Forum and Project Team members shall serve as representatives of an organization, company, or service provider. Members of the Board of Trustees, Council of Experts, and Expert Committees may participate in Stakeholder Forum and Project Team discussions, but only as representatives of USP.
- Advisory Nature. Stakeholder Forum and Project Team deliberations are advisory and are not binding in any way on the Council of Experts, its Expert Committees, or USP staff.
- Travel Expenses. When attending a meeting, Stakeholder Forum and Project Team members’ travel and accommodation arrangements and costs are the responsibility of the individual Stakeholder Forum or Project Team member, unless otherwise indicated by USP.
9.03 Stakeholder Forums
- Purpose. Stakeholder Forums shall be formed to enable an exchange of information and perspectives, with the ultimate goal of improving USP standards and information. Stakeholder Forums may exist in any region in which USP operates and may focus on any general compendial offering.
- Formation. The decision to form a Stakeholder Forum will be made by the CoE Chairperson. When establishing a Stakeholder Forum, the CoE Chairperson shall develop a specific charge for the Stakeholder Forum, including goals and expected outcomes. Multiple Stakeholder Forums can be formed and will continue until dissolved by the CoE Chairperson.
- Membership. Membership of Stakeholder Forums will consist of organization, company, and service provider representatives that may be affected by USP actions and who, in turn, might affect USP activities. Each representative organization may appoint up to three representatives to attend a Stakeholder Forum meeting; provided, however, that the CoE Chairperson shall have the right to limit or adjust the number of attendees from each organization to ensure balanced representation across constituencies. Membership may also include other individuals that the CoE Chairperson determines may provide useful insight or perspective on USP activities or the underlying science. The CoE Chairperson shall determine the organizations, companies, service providers and individuals that may be a member of a particular Stakeholder Forum. The CoE Chairperson shall assign a USP staff liaison to each Stakeholder Forum to serve as the USP contact and facilitate the work of the Stakeholder Forum.
- Chair. Stakeholder Forum members, with the advice and consent of the CoE Chairperson, will select the chairperson(s) of such Stakeholder Forum. Subsequent rotation of chairperson(s) of a Stakeholder Forum is at the Stakeholder Forum’s discretion. The chairperson(s) of a Stakeholder Forum leadership shall work with the USP liaison and other staff to create agendas for each meeting. The Stakeholder Forum may elect to create a planning committee to manage that activity. The chairperson(s) will preside over the Stakeholder Forum meetings.
- Meetings. Stakeholder Forum meetings may be held as face-to-face meetings at USP Headquarters or other locations, or via Web meeting. Dates and times will be posted on the USP website and are open to attendance by other interested individuals who may attend as observers.
- Reports. A final summary report of a Stakeholder Forum will be prepared at the close of the cycle by the Stakeholder Forum and USP.
9.04 Project Teams
- Purpose. Project Teams generally shall be formed to address a specific compendial topic (primarily process-oriented). Project Teams will function under a particular Stakeholder Forum.
- Formation. The formation of a Project Team may be initiated by the CoE Chairperson. A Stakeholder Forum may recommend formation of a Project Team to the CoE Chairperson. When forming a Project Team, the CoE Chairperson shall develop a specific charge for the Project Team, including goals and expected outcomes, with input from the related Stakeholder Forum. Project Teams will continue until completion of their charge or until dissolved by the Chairperson.
- Membership. Members of Project Teams shall be appointed by the CoE Chairperson, based on recommendations from the related Stakeholder Forum and/or on their scientific or technical expertise. The CoE Chairperson shall determine the appropriate number and type of representatives on the Project Team, with input from the Stakeholder Forum. The CoE Chairperson shall assign a USP staff liaison to each Project Team to serve as the USP contact and help facilitate the work of the Project Team.
- Chair. Each Project Team, with consent of the CoE Chairperson, shall select a Project Team chairperson. Subsequent rotation of chairpersons of a Project Team is at the Project Team’s discretion. The chairperson shall preside over the Project Team’s meeting(s) and will interact with the USP staff liaison and other USP staff on behalf of the Project Team.
- Meetings. Upon formation of a Project Team, an initial kick-off meeting shall be held with the Project Team and appropriate USP staff and Council of Experts or Expert Committee members. Subsequent meetings of the Project Team will occur as determined necessary by the Project Team, and may be face-to-face, via teleconference, or via Web meeting. USP staff shall attend such subsequent meetings as requested by the Project Team.
- Reports. Project Teams shall report progress to the appropriate Stakeholder Forum. The Project Team shall provide periodic reports as requested by USP staff and on completing its charge, shall prepare a final report with conclusions and recommendations. USP staff will respond to the issues, in writing, as appropriate and necessary.


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