2014 FDA Forum Agenda

MDMA 2014 FDA Forum

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AGENDA

Wednesday, March 5, 2014

8:00am - 8:55am

Registration and Continental Breakfast

8:55am - 9:00am

Welcome and Opening Remarks

  • Mark Leahey, President & CEO, MDMA

9:00am - 9:30am

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

  •  John Manthei, Partner, Latham & Watkins, LLP

9:30am - 10:30am

Recent Trends in Device Review Process

  • Christy Foreman, Director, CDRH's Office of Device Evaluation
  • Mark Gordon, Divisional Vice President, Regulatory Affairs, Abbott Medical Optics
  • Phil Phillips, President & CEO, Phillips Consulting Group
  • Daniel Schultz, Senior Vice President, Greenleaf Health, LLC

10:30am - 10:45am

Networking Break

10:45am - 11:30am

Navigating Today's 510(k) Program

  • Christy Foreman, Director, CDRH's Office of Device Evaluation
  • Mark Gordon, Divisional Vice President, Regulatory Affairs, Abbott Medical Optics
  • Heather Rosecrans, Vice President, Regulatory Affairs, MDMA

11:30am - 12:15pm

Clinical Trial Considerations

  • Lori E. Adels, Ph.D., Executive Vice President of Regulatory, Experien Group, LLC
  • Christy Foreman, Director, CDRH's Office of Device Evaluation

12:15pm - 1:15pm

Buffet Lunch

1:15pm - 1:45pm

New World of DeNovo

  • Mike Billig, Co-Founder & CEO, Experien Group, LLC
  • Christy Foreman, Director, CDRH's Office of Device Evaluation

1:45pm - 2:45pm

PMA Review Considerations

  • Christy Foreman, Director, CDRH's Office of Device Evaluation
  • Phil Phillips, President & CEO, Phillips Consulting Group

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 - 5:00pm

Applying Lessons Learned - Illustrations

5:00pm - 6:00pm

Networking Reception

 

Thursday, March 6, 2014

8:00am - 9:00am

Registration and Continental Breakfast

9:00am - 9:45am

CDRH Update

  • Christy Foreman, Director, CDRH's Office of Device Evaluation

9:45am - 10:45am

MDUFA III

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

10:45am - 11:00am

Networking Break

11:00am - 11:45am

Implementing UDI

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

11:45am - 12:30pm

Key Post Market Initiatives

via video conference

  • Steven Silverman, Director, Office of Compliance, FDA

12:30pm - 1:30pm

Buffet Lunch

1:30pm - 2:15pm

Best Practices in Compliance

  • Sonali Gunawardhana, Counsel, FDA Practice Group, Wiley Rein LLP
  • Elaine Tseng, Partner, King & Spalding

2:15pm - 3:00pm

Pros & Cons of Parallel Review

  • Karen Becker, Managing Director, Precision for Medicine
  • David Parker, Vice President, Market Access Strategy, Precision for Medicine

 

         

 

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.