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San Diego Convention Center

Jun 15, 2014 8:30 AM - Jun 19, 2014 12:45 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

Challenges and Opportunities Facing FDA’s International Posts

Session Chair(s)

Leslie  Ball, MD

Leslie Ball, MD

Assistant Commissioner and Deputy Director, OIP, OC, FDA, United States

The FDA has posts in eleven international locations that perform outreach to foreign regulators and industry, collect and share intelligence and information, and perform foreign facility inspections. This session will include directors of FDA’s international offices in China, India, and Latin America, who will discuss the major activities of FDA’s international posts, how the international offices align with other FDA Centers and Office of Regulatory Affairs, and the challenges they face in advancing the FDA mission internationally.

Learning Objective : Discuss strategies FDA uses to minimize risks to regulated products and global supply chains; Examine international efforts, including trade and cooperative agreements, to build capacity and leverage resources.

Speaker(s)

Christopher Jon Hickey, PHD

Christopher Jon Hickey, PHD

Senior Director, Public Affairs, Asia-Pacific, Pfizer Inc, United States

FDA in China

Atul  Agrawal

Atul Agrawal

Branch Chief, Office of Regulatory Affairs, U.S. Food and Drug Administration, United States

FDA in India

Michael C. Rogers, MS

Michael C. Rogers, MS

Associate Commissioner, Office of Regulatory Affairs< OC, FDA, United States

FDA in Latin America

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