2018 MDMA FDA Forum Agenda


                    

*Speakers will be added as confirmed

Click Here for a PDF of the Agenda

Monday, March 12, 2018

12:00pm - 12:55pm

Registration & Box Lunch

12:55pm - 1:00pm

Welcome, Opening Remarks

  • Mark Leahey, President & CEO, MDMA

1:00pm - 2:00pm

 Recent Trends, Real World Evidence & Patient Preference Testing

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA
  • Daniel Schultz, Principal, Medical Devices and Combination Products, Greenleaf Health, LLC

2:00pm - 2:45pm

 Navigating the 510(k) Program

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

2:45pm - 3:30pm

Do's & Don't's of Pre-Submission Meetings

  • Nada Hanafi, Chief Strategy Officer, Experien Group
  • Soma Kalb, PhD, Director, IDE Program, Clinical Trials Program, Office of Device Evaluation, CDRH, FDA (via video conferencing)

 3:30pm -3:45pm

Networking Break

3:45pm -4:30pm

De Novo Program

  • Mike Billig, Co-Founder & CEO, Experien Group
  • Sergio de del Castillo, De Novo Program Lead, Office of Device Evaluation, CDRH, FDA (via video conferencing)

4:30pm - 5:15pm

PMA Review Considerations

  • Amanda Klingler, Partner, FDA & Life Sciences, King & Spalding LLP
  • Joshua Nipper, Chief of Premarket Approval Staff, Office of Device Evaluation, CDRH, FDA

5:15pm - 6:30pm

Networking Reception

Tuesday, March 13, 2018

7:30am - 8:00am

Registration and Continental Breakfast

8:00am - 8:45am

CDRH Update

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA

8:45am - 9:30am

Key Issues Impacting IVD's

  • Elizabeth Hillebrenner, Associate Director for Programs and Performance, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA
  • Peter Shearstone, Vice President, RA/QA/Clinical and Medical Affairs, Sysmex America, Inc.

9:30am - 10:15am

Emerging Issues

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA
  • Yarmela Pavlovic, Partner, Hogan Lovells

10:15am - 10:30am

Networking Break

10:30 - 11:15am

Cybersecurity

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA

11:15am - 12:00pm

Inspections

  • Sean Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, FDA
  • Elaine Tseng, Partner, King & Spalding

12:00pm - 1:00pm

Networking Lunch

1:00pm - 1:45pm

Overview of Important Guidance's

  • Angela Krueger, Deputy Director for Engineering and Science Review (Acting), Office of Device Evaluation, CDRH, FDA (via video conferencing)

1:45pm - 2:30pm

Strategies to Succeed During the Review Process

  • Abiy Desta, Ombudsman, CDRH, FDA (via video conference)
  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA

2:30pm - 2:45pm

Networking Break

2:45pm - 3:30pm

Combination Products

  • John Weiner, Associate Director for Policy & Product Classification Officer, Office of Combination Products, FDA

3:30pm - 4:15pm

Digital Health

  • Craig Coombs, President, Coombs Medical Device Consulting
  • Anna Libman, Director, Regulatory Affairs, Experien Group
  • Bakul Patel, Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
  • Jafar Shenasa, Vice President, Regulatory Affairs, Proteus Digital Health, Inc.

         

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.