2017 MDMA FDA Forum Agenda


                    

*Speakers will be added as confirmed

Click Here for a PDF of the Agenda

Wednesday, March 8, 2017

7:30am - 8:15am

 Registration and Continental Breakfast

8:15am - 8:20am

 Welcome, Opening Remarks & Introductions

  • Mark Leahey, President & CEO, MDMA

8:20am - 9:00am

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

  • Phil Phillips, President & CEO, Phillips Consulting Group

 9:00am - 10:00am

Recent Trends in Device Review Process

  • Tamima Itani, Vice President, Global Regulatory Affairs, Boston Scientific Group
  • Phil Phillips, President & CEO, Phillips Consulting Group
  • Daniel Schultz, Principal, Medical Devices and Combination Products, Greenleaf Health LLC
  • John Sheets, Director, Office of Devices, CDRH, FDA

10:00am - 10:20am

Networking Break

10:20am - 11:15am

Navigating Today's 510(k) Program

  • Heather Rosecrans, Vice President, Regulatory Affairs, MDMA
  • Marjorie Shulman, Director, Premarket Notification (510(k)) Program, Program Operations Staff, Office of Devices, CDRH, FDA

11:15am - 12:00pm

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

  • Mark Gordon, Divisional Vice President, Regulatory Affairs, Abbott Medical Optics
  • Barbara Zimmerman, Deputy Director, Premarket Program Management, Office of Device Evaluation, CDRH, FDA

12:00pm - 1:00pm

Buffet Lunch

1:00pm - 1:30pm

The Evolving De Novo Program

  • Mike Billig, Co-Founder & CEO, Experien Group
  • Barbara Zimmerman, Deputy Director, Premarket Program Management, Office of Device Evaluation, CDRH, FDA

1:30pm - 2:15pm

PMA Review Considerations

  • Phil Phillips, President & CEO, Phillips Consulting Group
  • Barbara Zimmerman, Deputy Director, Premarket Program Management, Office of Device Evaluation, CDRH, FDA

2:15pm - 2:30pm

Networking Break

2:30pm - 3:15pm

Understanding the Changing Landscape of Combination Products

  • Craig Coombs, President, Coombs Medical Device Consulting
  • Thinh Nguyen, Director, Office of Combination Products, FDA
  • John Weiner, Associate Director for Policy & Product Classification Officer, Office of Combination Products, FDA
  • Suzanne O'Shea, Director, Healthcare and Life Sciences Disputes, Regulatory, Compliance, Investigations, Navigant (moderator)

3:15pm - 4:30pm

Best Practices when Interacting with FDA

  • Mark Gordon, Divisional Vice President, Regulatory Affairs, Abbott Medical Optics
  • Tamima Itani, Vice President, Global Regulatory Affairs, Boston Scientific Corporation
  • John Sheets, Director, Office of Devices, CDRH, FDA

4:30pm - 5:30pm

Applying Lessons Learned - Illustrations

Facilitated by Craig Coombs, President, Coombs Medical Device Consulting, Inc.

  • All Speakers

5:30pm - 6:30pm

Networking Reception

Thursday, March 9, 2017

7:00am - 8:00am

Registration and Continental Breakfast

8:00am - 8:45am

CDRH Update

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

8:45am - 9:30am

Narrowing the Gap Between Regulatory & Reimbursement

  • Jo Carol Hiatt, MD, MBA, Chair, National Product Council, Assistant Medical Director, SCPMG Business Administration, Kaiser Permanente
  • Murray Sheldon, Associate Director for Technology and Innovation, CDRH, FDA

9:30am - 10:15am

MDUFA IV and 21st Century Cures Update

  • Mark Gordon, Divisional Vice President, Regulatory Affairs, Abbott Medical Optics
  • Tamima Itani, Vice President, Global Regulatory Affairs, Boston Scientific Corporation
  • Barbara Zimmerman, Deputy Director, Premarket Program Management, Office of Device Evaluation, CDRH, FDA
  • Mark Leahey, President & CEO, MDMA (moderator)

10:15am - 10:30am

Networking Break

10:30am - 11:15am

Digital Health

  • Kristin Crosland, Chief Operating Officer, Experien Group
  • Bakul Patel, Associate Director for Digital Health, Office of Center Director, CDRH, FDA

11:15am - 12:00pm

Emerging Issues

  • Yarmela Pavlovic, Partner, Hogan Lovells
  • John Sheets, Director, Office of Devices, CDRH, FDA
  • Murray Sheldon, Associate Director for Technology and Innovation, CDRH, FDA

12:00pm - 1:00pm

Inspections

  • Steven Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding, LLP
  • Elaine Tseng, Partner, FDA & Life Sciences Group, King & Spalding, LLP

1:00pm

Conclusion Box Lunches


         

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.