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Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
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APPENDIXES

Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
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APPENDIX A
WORKSHOP AGENDA

Tuesday, April 22, 2003

7:45 AM

Continental Breakfast

8:30 AM

Welcome and Introduction

Robert Nerem, BEMA Chair

8:35 AM

Setting the Context: Scientist/Engineer

John Watson, NIH

8:55 AM

Setting the Context: Clinician

Renu Virmani, Armed Forces Institute of Pathology

9:15 AM

Setting the Context: Risk/Benefit Ratio

Paul Citron, Medtronic, Inc.

9:35 AM

Discussion

All

10:00 AM

Break

10:30 AM

Science-Based Testing for Devices

Aric Kaiser, FDA

10:45 AM

Science-Based Testing for Biologics

Darin Weber, FDA

11:00 AM

Experimental Design Technologies

Jim Rutledge, DataVision

11:30 AM

Discussion

All

12 NOON

Lunch

1:00 PM

Scientific and Process Design

Steve LaRiviere, Boeing

1:30 PM

Discussion

All

1:45 PM

BMP-Orthopedic Repair

Session Chair: Joshua Jacobs, Rush Medical College

1:45 PM

Overview of Science and Test Methods

Barbara Boyan, Georgia Institute of Technology

Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
×

2:05 PM

Industry Presentation

Amy LaForte, Stryker Biotech

2:25 PM

Industry Presentation

Bill McKay, Medtronic Sofamor Danek

2:45 PM

Discussion

All

3:15 PM

Break

3:45 PM

Drug-Eluting Stents

Session Chair: Terry Woods, FDA

3:45 PM

Clinician Presentation

Robert Schwartz, Minneapolis Heart Institute

4:05 PM

Industry Presentation

Semih Oktay, CardioMed

4:25 PM

Industry Presentation

Ronald Sahatjian, Boston Scientific Corporation

4:45 PM

Discussion

All

5:15 PM

Break

5:30 PM

Biofilms and Medical Devices

William Costerton, Montana State University

6:15 PM

Reception

Great Hall, NAS Building

7:15 PM

Adjourn

Wednesday, April 23, 2003

7:45 AM

Continental Breakfast

All

8:30 AM

Ethics Presentation

Leonard Weber, University of Detroit

9:00 AM

Cell-Matrix Cartilage Implants

Session Chair: Crystal Cunanan, Edwards Lifesciences

Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
×

9:00 AM

Clinician Presentation

Richard Coutts, University of California at San Diego

9:20 AM

Industry Presentation

Jim Burns, Genzyme

9:40 AM

Industry Presentation

Anthony Ratcliffe, Synthasome, Inc.

10:00 AM

Discussion

All

10:30 AM

Break

11:00 AM

General Discussion

All

12 NOON

Adjourn

Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
×
Page 27
Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
×
Page 28
Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
×
Page 29
Suggested Citation:"APPENDIX A: Workshop Agenda." National Research Council. 2004. Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices. Washington, DC: The National Academies Press. doi: 10.17226/11035.
×
Page 30
Next: APPENDIX B: Biographies of Speakers and Session Chairs »
Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices Get This Book
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The Food and Drug Administration (FDA) has established testing centers for assessment of three categories of medical products; devices, biologics, and drugs. Increasingly, however, medical products are appearing that are combinations of more than one of those categories. The FDA is just beginning to develop procedures for evaluating such combination products, which pose new challenges for assessing efficacy and safety. The Roundtable on Biomedical Engineering Materials and Applications (BEMA) is an NRC activity that brings together relevant parties to discuss R&D, applications, and regulation of biomedical materials and devices. In 2003, BEMA held a workshop to discuss science-based assessment for evaluation of combination products. This report and accompanying CD present abstracts and viewgraphs of the talks given at that workshop. The workshop focused on three specific types of combination products: orthopedic repair using morphogenetic protein, drug-eluting stents, and cell-matrix cartilage implants. In addition, context-setting discussions of science-based assessment and experimental design were presented at the workshop.

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