1 U.S. Food and Drug Administration International Programs Melinda K. Plaisier Assistant Commissioner for International Programs U.S. Food and Drug Administration U.S. Department of Health and Human Services Embassy Seminar November 6-7, 2003 Silver Spring, MD

2 FDA’s International Programs Goals Effect an affirmative public health agenda in the international arena Enhance and maximize FDA’s communications and interactions globally Assure FDA’s international goals and objectives are complimentary to and consistent with the Department and Administration’s goals Leverage resources with counterpart agencies on a risk-based basis

3 FDA’s International Programs Scope of Work Regulatory Cooperation and Enforcement Harmonization of Regulatory Policy and Scientific Standards Trade Negotiations and Trade Agreements Technical Assistance and Training Outreach and Education Scientific Collaboration and Exchange

4 FDA’s International Activities Methods Participation in Established International Forums Multilateral Work, such as Trilateral Cooperation Bilateral Cooperation Activities can be conducted, in an individual country, in a region, or in the U.S. and they can be a joint effort between two or more U.S. Executive Branch agencies, or just by FDA

5 FDA’s International Programs Who FDA’s International Work Is A Collaboration Between the Office of International Programs in the Office of the Commissioner and International Staff in each Programmatic Center and the Office of Regulatory Affairs.

6 FDA’s International Staff Center for Biologics Evaluation and Research: Joan Blair Center for Drug Evaluation and Research: Justina Molzon Center for Devices and Radiological Health: Christine Nelson & 3 Staff Center for Food Safety and Applied Nutrition: Cathy Carnevale & 9 Staff Center for Veterinary Medicine: Merton Smith Office of Regulatory Affairs: Millie Barber Office of International Programs: Mel Plaisier & 31 Staff

7 Office of International Programs The Office of International Programs provides leadership, management, coordination, and/or staffing services for all international activities for FDA. OIP also serves as the primary liaison between FDA and the Department of Health and Human Services’ Office of Global Health Affairs.

8 Office of International Programs

9 Desk Officers Dr. Patrick Wilson, Associate Director for Africa, the Middle East, Eastern Europe and EU Member States – (301) Julia Ho, Associate Director for Asia and the Pacific – (301) Minna Golden, Associate Director for the Americas (North America) – (301) Charles Gaylord, Associate Director for Central and South America, and the Caribbean – (301) Marilyn Veek, Associate Director for Communications – (301)

10 FDA’s International Programs Challenges Scope of Work versus Resources and Time

11 Addressing the Challenges Strategic Planning Examining the scope of work and setting priorities based on the Agency’s strategic plan; Department and Administration initiatives Leveraging Identifying ways to better coordinate international activities across the agency Exploring options or opportunities for partnering with the Department or other Exec. Branch Agencies and other outside organizations