2016 FDA Forum Agenda

MDMA 2016 FDA Forum


         

*Speakers will be added as confirmed

Click here for a pdf of Agenda

Wednesday, March 16, 2016

8:00am - 8:30am

   Registration & Continental Breakfast

8:30am - 9:00am

   Welcome, Opening Remarks & Introductions

  • Mark Leahey, President & CEO, MDMA

9:00am - 9:30am

   U.S. Food & Drug Administration's Regulation of Medical Devices - Overview

  • Phil Phillips, President & CEO, Phillips Consulting Group

9:30am - 10:15am

   Recent Trends in Device Review Process

  • Tamima Itani, Vice President, Global Regulatory Affairs, Boston Scientific Corporation
  • William Maisel, MD, MPH, Deputy Director for Science & Chief Scientist, CDRH, FDA
  • Phil Phillips, President & CEO, Phillips Consulting Group
  • Daniel Schultz, MD, Principal, Medical Devices and Combination Products, Greenleaf Health, LLC

    10:15am - 10:30am

       Networking Break

    10:30am - 11:15am

       Navigating Today's 510(k) Program

    • Heather Rosecrans, Vice President, Regulatory Affairs, MDMA
    • Marjorie Shulman, Chief of Premarket Notification (510(k)) Section, CDRH, FDA

      11:15am - 12:00pm

         Clinical Trial Considerations

      • Karen Becker, Managing Director, Precision for Medicine

        12:00pm - 1:00pm

           Buffet Lunch

        1:00pm - 1:30pm

           The Growing De Novo Program

        • Michael Billig, Co-Founder & CEO, Experien Group
        • William Maisel, MD, MPH, Deputy Center Director for Science & Chief Scientist, CDRH, FDA

          1:30pm - 2:00pm

             Do's & Don'ts of Pre-Submission Meetings

          • Mark Gordon, Division Vice President, Regulatory Affairs, Abbott Medical Optics
          • William Maisel, MD, MPH, Deputy Center Director for Science & Chief Scientist, CDRH, FDA

            2:00pm - 2:45pm

               PMA Review Considerations

            • William Maisel, MD, MPH, Deputy Center Director for Science & Chief Scientist, CDRH, FDA
            • Phil Phillips, President & CEO, Phillips Consulting Group

            2:45pm - 3:00pm

               Networking Break

            3:00pm - 3:45pm

               Combination Products

            • Michael Billig, Co-Founder & CEO, Experien Group
            • Mir Imran, Chairman & CEO, InCube Labs
            • John Weiner, Associate Director for Policy & Product Classification Officer, Office of Combination Products, FDA

              3:45pm - 4:15pm

                 Best Practices When Interacting with FDA

              • Tamima Itani, Vice President, Global Regulatory Affairs, Boston Scientific Corporation
              • Marjorie Shulman, Chief of Premarket Notification (510(k)) Section, CDRH, FDA

              4:15pm - 5:30pm

                 Applying Lessons Learned - Illustrations (All Speakers)

              facilitated by Craig Coombs, President & CEO, Coombs Medical Device Consulting, Inc.

              5:30pm - 6:30pm

                 Networking Reception

              Thursday, March 17, 2016

              7:30am - 8:30am

                 Registration & Continental Breakfast

              8:30am - 9:15am

                 CDRH Update

              • William Maisel, MD, MPH, Deputy Center Director for Science & Chief Scientist, CDRH, FDA

              9:15am - 10:00am

                 Emerging Issues: CyberSecurity, Digital Health

              • Nathan Brown, Partner, Akin Gump
              • Yarmela Pavlovic, Partner, Hogan Lovells

              10:00am - 10:15am

                 Networking Break

              10:15am - 10:45am

                 E-Submissions (via video conferencing)

              • Patrick Axtell, PhD, Program Operations Staff, Office of Device Evaluation, FDA

              10:45am - 11:15am

                 Independent Assessment

              • Matt Healy, Project Manager, Booz Allen Hamilton

              11:15am - 12:00pm

                 Deciding When a Modified Device Requires a 510(k)

              • Pamela Furman Forrest, Partner, King & Spalding
              • Lynette Zentgraft, Consultant, King & Spalding

              12:00pm

                 Conclusion - Box Lunch


                

                           

               

              Sessions and speakers are subject to change without notice. MDMA reserves the right to cancel or reschedule any program, whereupon full registration fees will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of canceled programs, MDMA assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.