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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