Read "Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report" at NAP.edu

Page 63 Cite

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.

×

Appendix A
Workshop Agenda

Hotel Monaco

Paris Ballroom

700 F Street, NW

Washington, DC 20004

Monday, June 14, 2010

8:30 AM	Welcome and Opening Remarks David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
8:50	Legislative History of the Medical Device Amendments of 1976 Peter Barton Hutt, Covington & Burling, LLP
9:30	Premarket Notification: A Key Element of US Medical Device Regulation Philip J. Phillips, PCG, LLC Larry Kessler, University of Washington, School of Public Health (coauthor)
10:10	Break
10:30	FDA’s Compliance Infrastructure Timothy A. Ulatowski, Director, Office of Compliance, Center for Devices and Radiological Health, FDA

Page 64 Cite

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.

×

11:10	Structure of the Medical Device Industry Innovation Ecosystem Josh Makower, Consulting Associate Professor of Medicine, Stanford University Biodesign Program, and Founder and CEO, ExploraMed Development, LLC
12:00 PM	Lunch
1:30	Impact of the Regulatory Framework on Medical Device Development and Innovation David W. Feigal, Jr., Vice President, Global Regulatory, Amgen, and Associate Faculty, Arizona State University School of Law
2:10	Balancing Patient Safety and Innovation Panel Discussion Moderated by William Vodra, Committee Member Panelists: Workshop speakers: David W. Feigal, Jr., Peter Barton Hutt, Josh Makower, Philip Phillips, and Tim Ulatowski Amy Allina, Program and Policy Director, National Women’s Health Network D. Bruce Burlington, Independent Consultant William Vaughan, Consultant, Consumer’s Union
3:00	Break
3:15	Public Comment—Registered Speakers
5:30	Recess

Tuesday, June 15, 2010

8:30 AM

Welcome

David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

8:40

Comparative Overview of Medical Device Regulatory Systems

David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy Department, Eisai Europe Ltd.

Page 65 Cite

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.

×

9:20	Past, Present and Future of Global Harmonization Janet Trunzo, Executive Vice President, Technology & Regulatory Affairs, Advanced Medical Technology Association (AdvaMed)
10:00	Update on PWC’s Medical Innovation Technology Score Card Doug Mowen,¹ Managing Director, Medical Device Industry Practice, PricewaterhouseCoopers
10:40	Break
10:50	The Global Regulatory Environment Panel Discussion Moderated by Kathryn Zoon, Committee Member Panelists: David W. Feigal, Jr., David Jefferys, and Janet Trunzo
11:30	Public Comment—Registered Speakers
12:30 PM	Adjourn

¹	This presentation was given by Janet Trunzo on behalf of Doug Mowen, who was unexpectedly unable to attend the workshop.

Page 66 Cite

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.

×