Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report (2010)
Chapter: Appendix A: Workshop Agenda
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 |
|
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:
|
|
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. |
|
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:
|
|
11:30 |
Public Comment—Registered Speakers |
|
12:30 PM |
Adjourn |
