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Challenges and Opportunities Facing FDA’s International Posts

Track:
Global Regulatory

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
376

Room Number:
11B

Level:
Advanced

Type:
Session

Title:
Challenges and Opportunities Facing FDA’s International Posts

Chair(s):
Leslie Ball, MD
Assistant Commissioner and Deputy Director, OIP, OC
FDA, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
FDA in China
Christopher Jon Hickey, PhD
Country Director, China Office, OIP, OC
FDA, China

FDA in India
Atul Agrawal
Supervisory Consumer Safety Officer, India Office, OIP, OC
FDA, United States

FDA in Latin America
Michael C. Rogers, MS
Director, Latin America Regional Office, OIP, OC
FDA, Costa Rica