Rules and Procedures of the 2005–2010 Council of Experts

13. Meetings

13.01 Expert Committee and ad hoc Advisory Panel Meetings

(a) Open Meetings. In accordance with USP's Open Meeting Policy, a meeting of an Expert Committee or ad hoc Advisory 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 ad hoc Advisory Panel or the CoE Chairperson determines that there is good and sufficient reason for closure. Such reasons may include, without limitation: 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. If the determination is made to close a meeting, such determination and the reason for closure shall be noted in the minutes of such meeting, and any non-member participants attending such meeting (other than Government Liaisons, as described in Section 13.04(c) below) shall be excused from the meeting.

(b) Teleconferences. An Expert Committee or ad hoc Advisory Panel may hold a meeting by means of a conference telephone call, computer technology, or other communications equipment by means of which all persons participating in the meeting shall hear one another or perceive each other's comments in the same period of time. Participation by such means shall constitute presence in person at a meeting. A meeting held by means of a telephone conference call, computer technology, or other communications equipment shall provide an opportunity for public listening, viewing, and comment unless the meeting is closed as provided above.

13.02 Division Executive Committee, Executive Committee, and Council of Experts Meetings

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

13.03 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 Web site. To the extent possible, minutes of Expert Committee meetings shall be posted on the USP Web site, excluding minutes from any closed portion thereof.

13.04 Non-member Participants in Expert Committee or ad hoc Advisory Panel Meetings

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

(a) 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 ad hoc Advisory 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 ad hoc Advisory Panel chairperson shall ask the invited guest to be excused during a confidential discussion or deliberation.

(b) Observer. Observers are non-members who themselves choose to attend the Expert Committee or ad hoc Advisory Panel meeting. Observers must notify the Scientific Liaison 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 ad hoc Advisory 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 Scientific Liaison or chair of the Expert Committee or ad hoc Advisory Panel.

(c) Government Liaison. Government Liaisons are representatives from the FDA or other domestic or foreign government agencies who desire to participate in an Expert Committee or ad hoc Advisory 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 ad hoc Advisory 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.

13.05 Working Sessions and Status Conferences

Two or more members of an Expert Committee or ad hoc Advisory Panel may engage in informal dialogue and working sessions as part of their work, and an Expert Committee or ad hoc Advisory 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 ad hoc Advisory Panel as provided herein. Except as provided in Section 9.07 above, any decision on any substantive issue shall be made by an Expert Committee or ad hoc Advisory Panel only at a meeting called and conducted in accordance with the provisions of Sections 13.01 through 13.04 above.