Rules & Procedures of the 2010–2015 Council of Experts

10. Meetings

10.01 Expert Committee & Expert Panel Meetings

1. Open Meetings. In accordance with USP’s Open Meeting Policy, a meeting of an Expert Committee or Expert Panel shall be open to the public, except that a meeting or a portion of a meeting may be closed if the chairperson of the Expert Committee or Expert Panel or the CoE Chairperson determines that there is good and sufficient reason for closure. Such reasons may include, and are not limited to: review or discussion of trade secret or confidential, commercial information; or review or discussion of matters the premature disclosure of which could be detrimental to the USP.
2. Closed Meetings. If the determination is made to close a meeting, such determination and the reason for closure shall be announced at the beginning of the meeting and noted in the meeting minutes. Any non-member participants attending such meeting (other than FDA or other Government Liaisons, as described in 10.04(b) below) shall be excused from the meeting.
3. Teleconferences. An Expert Committee or Expert Panel may hold a meeting by means of a teleconference, web meeting, or other communications mechanism by which all persons participating in the meeting can hear one another or perceive each other’s comments. Participation by such means shall constitute presence in person at a meeting. A meeting held by means of a teleconference, Web meeting, or other communications mechanism shall provide an opportunity for public participation unless the meeting is closed as provided above.

10.02 Council of Experts & Executive Committee Meetings

Meetings of the Council of Experts and Executive Committee shall be closed unless otherwise indicated.

10.03 Announcement of Public Meetings & Minutes

To the extent possible, all USP open meetings shall be announced beforehand by appropriate means, which shall include the USP website. Minutes of Expert Committee and Expert Panel meetings shall be available by requesting them from the USP Executive Secretariat, excluding minutes from any closed portion thereof.

10.04 Non-member Participants in Expert Committee or Expert Panel Meetings

When a USP meeting is open to the public, a non-member may participate in one of three ways:

1. Invited Guest. Invited guests are non-members who are invited specifically to share a particular expertise or express their particular point of view. This shall be carried out under the control of the chairperson of the Expert Committee or Expert Panel and shall be subject to the Rules and Procedures of the Council of Experts. These non-members shall be provided with appropriate briefing materials, excluding confidential information. The Expert Committee or Expert Panel chairperson shall ask the invited guest to be excused during a confidential discussion or deliberation.
2. Government Liaisons. Government Liaisons are representatives from the Food and Drug Administration or other governmental agencies in the U.S. or other countries who desire to participate in an Expert Committee or Expert Panel in their capacity as government employees. Government Liaisons generally shall receive briefing materials and be allowed to participate in confidential discussions occurring at a meeting, provided that they have signed confidentiality agreements for such meeting requiring them to keep all such information confidential except to the extent limited disclosure within the respective agency is required in the performance of their governmental duties. The Expert Committee or Expert Panel chairperson may ask a Government Liaison to excuse himself or herself during any discussion or deliberation in which the chairperson believes such Government Liaison’s participation would not be appropriate due to confidentiality, conflict or other reasons.
3. Observers. Observers, including press and representatives of government agencies not officially designated as Government Liaisons, are non-members who themselves choose to attend the Expert Committee or Expert Panel meeting. Observers must notify USP at least five business days in advance of the meeting (or as soon as possible after posting of the meeting notice and agenda) of their proposed attendance, and provide necessary background information about themselves. Observers may or may not receive briefing materials. USP retains the right to refuse permission for an observer to attend a meeting. The Expert Committee or Expert Panel chairperson shall ask the observer to excuse himself or herself during a confidential discussion or deliberation. Observers will be permitted to make presentations or otherwise speak at the meeting only if approved in advance by the chair of the Expert Committee or Expert Panel.

10.05 Working Sessions & Status Conferences

Two or more members of an Expert Committee or Expert Panel may engage in informal dialogue and working sessions as part of their work, and an Expert Committee or Expert Panel may hold informal teleconferences and online discussions to review the status of work being performed by members, without the need to call or conduct a formal meeting of the Expert Committee or Expert Panel as provided herein. Except as provided in Section 7.07 above, any decision on any substantive issue shall be made by an Expert Committee or Expert Panel only at a meeting called and conducted in accordance with the provisions of Sections 10.01 through 10.04 above.