2019 MDMA FDA Forum Agenda


                    

*Speakers will be added as confirmed

Click Here for a PDF of the Agenda

*Attendees receive up to 6 credits towards RAC re-certification upon completion

Thursday, March 14, 2019

7:30am - 8:25am

Registration & Continental Breakfast

8:25am - 8:30am

Welcome, Opening Remarks

  • Mark Leahey, President & CEO, MDMA

8:30am - 9:15am

Navigating the 510(k) Program

  • Heather Rosecrans, Vice President, Regulatory Affairs, MDMA
  • Marjorie Shulman, Director, Premarket Notification 510(k) and 513(g) Programs, Program Operations Staff, Office of Device Evaluation, CDRH, FDA

9:15am - 10:00am

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

  • Craig Coombs, President, Coombs Medical Device Consulting
  • Joshua Nipper, Director, PMA, HDE, & Q-Sub Programs, Program Operations Staff, Office of Device Evaluation, CDRH, FDA

10:00am - 10:20am

Networking Break

10:20am - 11:05am

De Novo Program

  • Michael Billig, Chief Executive Officer, Experien Group, LLC
  • Sergio M. de del Castillo, De Novo Program Lead, Office of Device Evaluation, CDRH, FDA

11:05am - 11:50am

PMA Review Considerations

  • Darlene Crockett-Billig, Co-Founder & President, Experien Group LLC
  • Amanda Klingler, Partner, King & Spalding
  • Joshua Nipper, Director, PMA, HDE & Q-Sub Programs, Program Operations Staff, Office of Device Evaluation, CDRH, FDA

11:50am - 12:30pm

Strategies to Succeed During the Review Process

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA
  • Heather Rosecrans, VP, Regulatory Affairs, MDMA

12:30pm - 1:30pm

Networking Lunch

1:30pm - 2:15pm

Combination Products

  • Daniel Schultz, Principal, Medical Devices and Combination Products, Greenleaf Health, LLC
  • John Weiner, Associate Director for Policy & Product Classification Officer, Office of Combination Products, FDA

2:15pm - 3:00pm

Digital Health

  • Craig Coombs, President, Coombs Medical Device Consulting
  • Bakul Patel, MSEE, MBA, Associate Center Director for Digital Health, Office of the Center Director, CDRH, FDA
  • Ron Warren, Vice President, Regulatory Affairs, Experien Group LLC

3:00pm -  3:15pm

Networking Break

3:15pm - 4:00pm

Key Issues Impacting IVD's

  • Peter Shearstone, Vice President, Global Quality Assurance & Regulatory Affairs, Thermo Fisher Scientific, Inc.
  • Timothy Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA

4:00pm - 4:45pm

Inspections

  • Cesar Perez, PhD, CQA, RAC, Director, Division of International Compliance Operations, Office of Compliance, CDRH, FDA
  • Jessica Ringel, Counsel, FDA & Life Sciences, King & Spalding
  • Elaine Tseng, Partner, King & Spalding

4:45pm -5:05pm

MDUFA Independent Assessment

  • Matt Healy, Principal, Booz Allen Hamilton

5:05pm - 6:00pm

Networking Reception

Friday, March 15, 2019

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 - 9:45am

Industry Reaction

  • Michael Billig, Chief Executive Officer, Experien Group, LLC
  • Mark Leahey, President & CEO, MDMA
  • Daniel Schultz, Principal, Medical Devices and Combination Products, Greenleaf Health, LLC

9:45am - 10:30am

Future of 510(k)?

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

10:30am - 10:45am

Networking Break

10:45am - 11:30am

MDUFA - Supported Patient Program

  • Nada Hanafi, Chief Strategy Officer, Experien Group, LLC
  • Kathryn M. O'Callaghan, Assistant Director for Strategic Programs, Office of the Center Director, CDRH, FDA
  • Michelle Tarver, Director, Patient Science & Engagement Program, Office of the Center Director, CDRH, FDA

11:30am - 12:00pm

Demonstration of eSTAR Platform

  • Patrick Axtell, Senior Tools & Templates Engineer, Office of Device Evaluation, CDRH, FDA

12:00pm - 1:00pm

ADJOURN - 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.