Agenda

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    • Wednesday, March 1, 2017
    •  
      1:00 PM  -  1:05 PM
      Welcome
      Hosts:
      1:05 PM  -  1:45 PM
      Statutory Authority for Advisory Panels
      • Purpose and authority for advisory committees
      • The Federal Advisory Committee Act (FACA)
      • Guidance documents on advisory panels
      • Rules of public meetings
      • Disclosure agreements and conflicts of interest
      1:45 PM  -  3:15 PM
      How FDA Uses Advisory Panels
      • The role of a medical device advisory panel for FDA
      • The selection of panel members
      • Panel member preparation
      • The review process: how do submissions go to panel?
      • Utilization of advisory panel results
      • Panels for classification and reclassification
      Moderators:
      3:15 PM  -  3:30 PM
      Break
      3:30 PM  -  4:45 PM
      Impact of Advisory Panels on the Sponsor
      • Reasons to participate in a panel
      • Reasons to avoid a panel
      • Public disclosure of data
      • What happens when things don’t go well?
      Moderators:
      5:00 PM 
      Adjournment for the Day
      5:00 PM  -  6:30 PM
      Reception
    • Thursday, March 2, 2017
    •  
      8:30 AM  -  9:00 AM
      Breakfast
      9:00 AM  -  10:15 AM
      Conducting Open Public Meetings - Procedures
      • Events leading up to the panel meeting
      • Panel pack and redaction
      • Public comment (with real videos)
      • Video and transcripts
      • Trade press, financial press, social media coverage
      Moderators:
      10:15 AM  -  11:00 AM
      Statistics
      • What are the panel members looking for?
      • Making complex statistical issues meaningful to the panel
      • Common pitfalls and how to avoid problems
      11:00 AM  -  11:15 AM
      Break
      11:15 AM  -  12:15 PM
      Technical Support
      • IT and AV support
      • Slides and back-ups
      • Back room resources – preparing for the unexpected
      Speakers:
      12:15 PM  -  1:15 PM
      Lunch
      1:15 PM  -  2:00 PM
      Clinical Studies and the IDE
      • Early sponsor-FDA discussions of appropriate studies and evidence and their impact on panel discussions and the PMA process
      Speakers:
      2:00 PM  -  4:00 PM
      Strategic Planning, Preparing, and Conduct

      All Faculty

      • Experiences
      • Best practices
      4:00 PM 
      Adjournment
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