Invited Speaker

Globalization of the US Food and Drug Administration: International Offices/Middle East Office: Mission and Goals.
Layla I. Batarseh
USA

The Office of International Programs of the U.S. Food and Drug Administration (FDA) strives to advance the mission of the FDA and public health worldwide in partnership with other FDA components, U.S. Government agencies, foreign governments (especially our foreign counterpart agencies), and international organizations. To work more closely and collaboratively with our foreign counterpart regulatory agencies, FDA has expanded its international engagement, including the creation of a Middle East Office that covers the countries of the Middle East and North Africa. Our objectives include even better collaboration with foreign regulatory authorities and other stakeholders to obtain better information on the safety and quality of FDA-regulated products exported to the United States; to provide assistance, when requested, to strengthen regulatory infrastructures and improve technical capacity for ensuring product safety and quality; and to facilitate the harmonization of international standards and guidelines. The Director of the USFDA Regional Office in the Middle East will present a brief synopsis of the globalization of the USFDA, its mission and objectives in the Middle East, and a short overview of what is required to get FDA approval for new drugs and for conducting clinical trials in the Middle East.