2015 FDA Forum Agenda

MDMA 2015 FDA Forum


         

*Speakers will be added as confirmed

Click here for a pdf of Agenda

Wednesday, March 11, 2015

8:00am - 8:55am

Registration & Continental Breakfast

8:55am - 9:00am

Welcome & Opening Remarks

  • Mark Leahey, President & CEO, MDMA

9:00am - 9:30am

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

  • Philip Desjardins, Counsel, Arnold & Porter LLP

9:30am - 10:30am

Recent Trends in Device Review Process

  • Mark Gordon, Divisional Vice President, Regulatory Affairs, Abbott Medical Optics
  • William Maisel, MD, MPH, Deputy Center Director for Science & Chief Scientist, CDRH
  • Daniel Schultz, Principal, Medical Devices and Combination Products, Greenleaf Health LLC

10:30am - 10:45am

Networking Break

10:45am - 11:30am

Navigating Today's 510(k) Program

  • Heather Rosecrans, Vice President, Regulatory Affairs, MDMA
  • Barbara Zimmerman, Deputy Director, CDRH, Office of Device Evaluation

11:30am - 12:15pm

Clinical Trial Considerations

  • Karen Becker, Managing Director, Translational & Regulatory Sciences, Precision for Medicine
  • Owen Faris, Clinical Trial Director, CDRH, Office of Device Evaluation *via video conference

12:15pm - 1:15pm

Buffet Lunch

1:15pm - 1:45pm

The Growing De Novo Program

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

1:45pm - 2:45pm

PMA Review Considerations

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

2:45pm - 3:00pm

Networking Break

3:00pm - 3:45pm

Combination Products

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

3:45pm - 4:15pm

UDI Implementation

  • Jay Crowley, Vice President & Practice Lead - UDI, USDM Life Sciences

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 12, 2015

8:00am - 9:00am

Registration & Continental Breakfast

9:00am - 9:45am

CDRH Update

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

9:45am - 10:45am

MDUFA Independent Assessment Update

  • Matt Healy, PhD, Associate, Booz Allen Hamilton
  • Barbara Zimmerman, Deputy Director, CDRH, Office of Device Evaluation

10:45am - 11:00am

Networking Break

11:00am - 12:00pm

Emerging Issues: Cybersecurity, Mobile Health & More

  • Nathan Brown, Partner, Akin Gump
  • Philip Desjardins, Counsel, Arnold & Porter LLP
  • William Maisel, MD, MPH, Deputy Center Director for Science & Chief Scientists, CDRH

12:00pm - 12:30pm

Key Post Market Initiatives

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

12:30pm - 1:30pm

Buffet Lunch

1:30pm - 2:30pm

Dealing with Inspections

  • Monica Burt, Senior Director, Global Quality and Tissue Bank Director, Wright Medical Technology
  • Pamela Furman Forrest, Partner, King & Spalding
  • Steven Niedelman, Consultant, King & Spalding

             

 

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.