Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

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Table of Contents
Front Matter R1-R18
Summary 1-12
1 Introduction 13-32
2 Core Elements of Regulatory Systems 33-78
3 Critical Issues 79-146
4 A Strategy to Building Food and Medical Product Regulatory Systems 147-164
5 International Action 165-192
6 Domestic Action 193-234
7 Conclusions and Priorities 235-242
Appendix A: Glossary 243-252
Appendix B: A Review of Tort Liability's Role in Food and Medical Product Regulation 253-272
Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China 273-282
Appendix D: Chinese Food Regulatory System 283-296
Appendix E: Meeting Agendas 297-318
Appendix F: Committee Member Biographies 319-328
Appendix G: Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed 329-344
Appendix H: Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration 345-348

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11:00-11:10

Break

SESSION 2—OPEN
QUESTIONS ON STATEMENT OF TASK

11:10-11:30	Project Timeline and Statement of Task Sponsor Representative Introductions Jim Riviere, Committee Chair
11:30-12:15	Questions to Sponsor
	Mary Lou Valdez, Associate Commissioner for International Programs, FDA
	Kate Bond, Associate Director for Technical Cooperation/Capacity-Building, FDA
12:15	Lunch

SESSION 3—OPEN
THE FDA PERSPECTIVE

Objective: To learn about the FDA’s current capacity and its international work.

12:45	Welcome the Public and Introduce Commissioner Hamburg Jim Riviere, Committee Chair
12:45-1:05	Keynote Address: Why is this study important to the FDA? Margaret Hamburg, Commissioner, FDA
1:05-1:25	Questions
1:25-2:30	What is the capacity of the FDA Centers? What are the key issues they face in international work?
	Deb Autor, Director, FDA Center for Drug Evaluation and Research
	Karen Midthun, Director, FDA Center for Biologics Evaluation and Research
	Lillian Gill, Senior Associate Director, FDA Center for Devices and Radiological Health
	Don Kraemer, Acting Deputy Director for Operations, FDA Center for Food Safety and Applied Nutrition

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