us food and drug administration: nmt05talkdapolitogail
TRANSCRIPT
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
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THE EXECUTIVE SECRETARY
Provides Administrative Oversight
Ensures Advisory Committee ProcessAdheres to Gov’t/FDA Regulationsand Policies
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THE EXECUTIVE SECRETARY
Advisory Committee ProcessIncludes:
Maintenance of Committee Charter Recruitment of New Members
Preparation and Conduct of ACMeetings
Designated Federal Official
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EXECUTIVE SECRETARYRESPONSIBILITIES
Prevent little problems from becoming bigissues
Coordinate activities of all meetingparticipants
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Executive
Secretary
Press
FDA Industry
General
Public
Committee
Member
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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
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COMMITTEE MEMBER RESPONSIBILITIES
ATTEND SCHEDULED MEETINGS
Schedules Set on Annual Basis
Emergency MeetingsCancelled Meetings
New Members Can Have Prior
Commitments
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COMMITTEE MEMBER RESPONSIBILITIES
ATTEND SCHEDULED MEETINGS
Entire Meeting
Notify Exec Sec Well in Advance if Unable to Attend
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COMMITTEE MEMBER RESPONSIBILITIES
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
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COMMITTEE MEMBER RESPONSIBILITIES
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
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COMMITTEE MEMBER RESPONSIBILITIES
BE AN ACTIVE PARTICIPANT
AGENDA
Issue Topics – FDA Medical/ProductReview Staff
Format – Exec Sec
Open/Closed Meeting PROTECT PRIVILEGED INFO
Input From Committee Chair
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COMMITTEE MEMBER RESPONSIBILITIES
BE AN ACTIVE PARTICIPANT
OPEN PUBLIC HEARING
Opportunity for Public To Address theCommittee on the Issue at Hand
Encouraged to Pre-Register withExec Sec
Questions Permitted by Committee
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COMMITTEE MEMBER RESPONSIBILITIES
BE AN ACTIVE PARTICIPANT
QUESTIONS
Primary Focus of Committee DiscussionOpen Committee Deliberations MustBe Public
Formulated by FDA Medical/ProductReview Staff
Can Change Up to Time of Meeting
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COMMITTEE MEMBER RESPONSIBILITIES
BE AN ACTIVE PARTICIPANT
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
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COMMITTEE MEMBER RESPONSIBILITIES
BE AN ACTIVE PARTICIPANT
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.*
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COMMITTEE MEMBER RESPONSIBILITIES
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
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COMMITTEE MEMBER RESPONSIBILITIES
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
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COMMITTEE MEMBER RESPONSIBILITIES
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
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THE EXECUTIVE SECRETARY
Point-of-Contact for all Matters Related toAdvisory Committee Service Assist You to Meet Your Responsibilities
as Committee Members
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YOUR SERVICE IS
INVALUABLE!
THANK YOU