2020 MDMA FDA Forum Agenda


                    

*Speakers will be added as confirmed

Click Here for a PDF of the Agenda


Thursday, March 12, 2020

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, Assistant Director 510(k), DeNovo, 513(g), Device Determinations & Custom Devices Lifecycle Team, Office of Product Evaluation & Quality, CDRH, FDA

9:15am - 10:00am

Best Practices in Pre-Submission Meetings

  • Mark Gordon, MS, RAC, FRAPS, Sr. VP & Global Head, Regulatory Affairs, Alcon Laboratories
  • Joshua Nipper, Director, Office of Regulatory Programs I, Office of Product Evaluation & Quality, CDRH, FDA
  • Daniel Schultz, M.D., Principal, Medical Devices & Combination Products, Greenleaf Health, Inc.

10:00am - 10:20am

Networking Break

10:20am - 11:05am

De Novo Program

  • Kit Cariquitan, Chief Regulatory Officer, Experien Group, LLC
  • Sergio M. de del Castillo, De Novo Program Lead, Premarket Notification & Classification Team, DRP1, Office of Product Evaluation & Quality, CDRH, FDA

11:05am - 11:50am

PMA Review Considerations

  • Amanda Klingler, Partner, King & Spalding
  • Joshua Nipper, Director, Office of Regulatory Programs 1, Office of Product Evaluation & Quality, CDRH, FDA

11:50am - 12:30pm

Strategies to Succeed During the Review Process

  • William Maisel, MD, MPH, Director, Office of Product Evaluation & Quality, CDRH Medical Officer, CDRH, FDA

12:30pm - 1:30pm

Networking Lunch

1:30pm - 2:15pm

Combination Products

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

2:15pm - 3:00pm

Digital Health

  • Craig Coombs, President, Coombs Medical Device Consulting, Inc.
  • Bakul Patel, MSEE, MBA, Director, Digital Health, CDRH, FDA

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, Office Director, Office of Health Technology 7, Office of Product Evaluation & Quality, CDRH, FDA

4:00pm - 4:45pm

Inspections

  • Cesar Perez, PhD, CQA, RAC, Director, DRP2: Division of Establishment Support, Office of Regulatory Programs, Office of Product Evaluation & Quality, CDRH, FDA
  • Jodi Scott, Partner, Hogan Lovells
  • Elaine Tseng, Partner, King & Spalding

4:45pm -5:15pm

Preparation for MDUFA V

  • Mark Leahey, President & CEO, MDMA

5:15pm - 6:30pm

Networking Reception


Friday, March 13, 2020

7:30am - 8:00am

Registration and Continental Breakfast

8:00am - 8:45am

CDRH Update

  • William Maisel, MD, MPH, Director, Office of Product Evaluation & Quality, CDRH Medical Officer, CDRH, FDA

8:45am - 9:30am

Industry Reaction

  • Mark Leahey, President & CEO, MDMA
  • Daniel Schultz, M.D., Principal, Medical Devices & Combination Products, Greenleaf Health, Inc.

9:30am - 10:15am

Collaborating with Patients to Advance Device Innovation

  • Nada Hanafi, Chief Strategy Officer, Experien Group, LLC
  • Kathryn M. O'Callaghan, Deputy Director, Office of Strategic Partnerships & Technology Innovation, CDRH, FDA
  • Michelle Tarver, M.D., Ph.D., Director, Patient Science & Engagement, Office of Strategic Partnerships & Technology Innovation, CDRH, FDA

 10:15am - 10:30am

Networking Break

10:30am - 11:15am

Breakthrough Devices Program/Safer Technologies Program Proposal (STeP) and Innovation

  • Michael Billig, Co-Founder & CEO, Experien Group, LLC
  • Owen Faris, Ph.D., Principal Deputy Director, Office of Product Evaluation & Quality, CDRH, FDA

11:15am - 12:00pm

Updates/Deployment/Future Plans for eSTAR & IVD eSTAR

  • Patrick Axtell, Ph.D., Senior Tools & Templates Engineer, Office of Regulatory Products, CDRH, FDA
  • Lili Duan, Ph.D, Chemist, Office of Regulatory Products, 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.