GMP Roundtable
Conference
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GMP Roundtable
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Charter:
Page 1 of 3 Version: 2August 2005
NAME: GMP ROUNDTABLE FOR CLINICAL SUPPLIES
PURPOSE: GMP Roundtable for Clinical Supplies was established to provide an open forum for dissemination and exchange of information among interested persons.
OBJECTIVE: To provide a forum for the open exchange of ideas and information relating to Quality and Compliance for Investigational Materials.
To foster professional relationships among participating personnel.
ORGANIZATION: The activities of the GMP Roundtable for Clinical Supplies will be guided by a Steering Committee. The Steering Committee should consist of a minimum of twelve members from research based Pharmaceutical companies including the host from the most recent annual meeting and the host from the upcoming annual meeting. Up to three additional members may be on the Steering Committee from Biopharmaceutical companies.
The Steering Committee shall meet at least once per year. The need for additional meetings shall be determined by the Steering Committee.
The Steering Committee shall be responsible for determining the program and for establishing all policies.
Page 2 of 3 Version: 2 August 2005 ________________________________________________________________________
Each year 4 to 5 members will be selected by the Steering Committee to replace retiring members. The term of office for members of the Steering Committee is three years. A second consecutive term for an individual steering committee member is acceptable if agreed by consensus. New volunteers for the Steering Committee will be solicited during the year and at the annual meeting. Selection will be by consensus of the Steering Committee members. The term of office will commence following the annual meeting at which they were selected.
MEETINGS: A meeting is held at least annually. Meetings are sponsored by a participant’s firm which bears the cost of the meeting. The meeting date, time and place shall be established by the host member of the Steering Committee. If a meeting cannot be sponsored by a participant’s firm, the Steering Committee will make appropriate arrangements for the meeting and a cost to members may be imposed.
PARTICIPATION: Attendance is open to all individuals interested or involved in development and/or manufacture of Clinical Supplies at any research based pharmaceutical firm, their affiliates and/or subsidiaries. Vendor, consultant and/or recruiter attendance will be considered on a case-by-case basis by the host and approved by consensus of the Steering Committee members.
REVISIONS: Revisions to the charter may be proposed by any GMP Roundtable for Clinical Supplies participant and evaluated by the Steering Committee.
Page 3 of 3 Version: 2August 2005
2005 Steering Committee Companies
Abbott Labs Adolor AstraZeneca Boehringer-Ingelheim Bristol Myers Squibb Eli Lilly Glaxo Smith Kline Johnson and Johnson Merck Novartis Pfizer Proctor and Gamble Sanofi-Aventis
Revised by the 2005 Steering Committee.
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