US Food and Drug Administration: NMT05TalkDapolitoGail

8/14/2019 US Food and Drug Administration: NMT05TalkDapolitoGail

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Role of theExecutive Secretary

Gail Dapolito

Advisory Committee Coordinator

Div. Scientific Advisors and

Consultants

Center for Biologics Evaluationand Research

http://ocs05/OSAC/NMT05/NMTTalks_Final_042005.ppt



THE EXECUTIVE SECRETARY

Provides Administrative Oversight

Ensures Advisory Committee ProcessAdheres to Gov’t/FDA Regulationsand Policies





Advisory Committee ProcessIncludes:

Maintenance of Committee Charter Recruitment of New Members

Preparation and Conduct of ACMeetings

Designated Federal Official





EXECUTIVE SECRETARYRESPONSIBILITIES

Prevent little problems from becoming bigissues

Coordinate activities of all meetingparticipants





Executive

Secretary

Press

FDA Industry

General

Public

Committee

Member





COMMITTEE MEMBER RESPONSIBILITIES

Attend scheduled meetings Read the briefing documents Be an active participant in the

committee discussions at each meeting Be prepared to vote Disclose conflicts of interest

Protect confidentiality of privilegedinformation Participate in FDA Site Visits Complete necessary documentation to

ensure proper compensation






ATTEND SCHEDULED MEETINGS

Schedules Set on Annual Basis

Emergency MeetingsCancelled Meetings

New Members Can Have Prior

Commitments






ATTEND SCHEDULED MEETINGS

Entire Meeting

Notify Exec Sec Well in Advance if Unable to Attend






READ THE BRIEFING DOCUMENTS Provided Approx. 3 Weeks Prior to

Meeting May Contain Confidential Information

Do Not Distribute

Public Version On Web Prior to

Meeting Refrain From Discussing Contact Exec Sec If Any Questions






BE AN ACTIVE PARTICIPANT How Is An AC Meeting Conducted?

Committees Meet at the Request of FDA

Chair “Runs” the Meeting

Variable Public Attendance

Agenda Developed by Division/ExecSec/Chair






BE AN ACTIVE PARTICIPANT

AGENDA

Issue Topics – FDA Medical/ProductReview Staff

Format – Exec Sec

Open/Closed Meeting PROTECT PRIVILEGED INFO

Input From Committee Chair







OPEN PUBLIC HEARING

Opportunity for Public To Address theCommittee on the Issue at Hand

Encouraged to Pre-Register withExec Sec

Questions Permitted by Committee







QUESTIONS

Primary Focus of Committee DiscussionOpen Committee Deliberations MustBe Public

Formulated by FDA Medical/ProductReview Staff

Can Change Up to Time of Meeting







Be Prepared to Comment on All Issues

and Questions for CommitteeDiscussion

Need to be Recognized by Chair

Ask Questions of Presenters

FDA Needs Your Comments During theMeeting







ADVICE RENDERED BY A COMMITTEE IS

MOST USEFUL TO THE AGENCY WHEN IT RESULTS FROM A PROCESS OF FULL

SCIENTIFIC INQUIRY FOLLOWED BY

THOUGHTFUL DISCUSSION, FRAMING OF

RECOMMENDATIONS, AND CLEAR

IDENTIFICATION OF THE REASONS FOR

THE RECOMMENDED ACTIONS.*






BE PREPARED TO VOTE Committee Polled for the Public Record

Yes/No/AbstainMust Be Present To Vote

Cannot Change Vote After MeetingAdjourns

Impact of Final Vote Who Can Vote

Determined by Charter

Affected by Potential Conflicts of Interest






DISCLOSE CONFLICTS OF INTEREST

Accurately Complete Paperwork

Return on Time FDA Needs Sufficient Time to Review

Cannot Participate at Meeting until

COI Paperwork Approved Disclosures Read Into Public Record

Product Approval Meetings






Participate in FDA Site Visits Complete and Return Post-Meeting

Paperwork

Ensures Proper Compensation

Assists FDA to Reconcile End-of-YearAccounts

Post-Meeting Information “Quick Minutes”

Transcripts

Official Minutes






Point-of-Contact for all Matters Related toAdvisory Committee Service Assist You to Meet Your Responsibilities

as Committee Members





YOUR SERVICE IS

INVALUABLE!

THANK YOU


Documents

US Food and Drug Administration: NMT05TalkDapolitoGail