PRESS RELEASE

October 3, 2006

United States Food and Drug Administration (USFDA) and Vietnam's Ministry of Health hold Good Clinical Research Practice Training Workshop

The U.S. Food and Drug Administration and Vietnam's Ministry of Health began a joint training workshop on good clinical research practices today in Hanoi.  This important joint effort which will be held from October 3-6, 2006 at the Hilton Hanoi Opera, was opened by U.S. Chargé d'affaires Jonathan Aloisi and Vice Minister of Health Professor Le Ngoc Trong.

This seminar will focus on building capacity for the promotion of good clinical research practice.  It is designed to enhance collaboration and information exchange among researchers, scientists, practitioners and regulators in both the human and animal health fields.

“This workshop focuses on building capacity for the promotion of Good Clinical Research Practice,” noted Mr. Aloisi.  “ It closely follows the Government of Vietnam’s strategy for preventing and, if necessary, responding to outbreaks of influenza.” 

Mr. Aloisi observed that “…Vietnam has succeeded in limiting the spread of avian influenza, because the Government has taken a strategic, multi-faceted approach to solving this problem. This approach includes the strengthening of health services capacity and scientific research capabilities, particularly diagnostic abilities and the development of human vaccines against avian influenza.”

During the 4-day workshop, two U.S. experts from the Food and Drug Administration will participate in discussions with over 30 Vietnamese doctors, lecturers and researchers from the Ministry of Health and various health institutes, medical universities and drug companies from around the country.  Topics will include the history and principles of Good Clinical Practice (GCP), Roles and Responsibilities Under GCP, Ethics Requirements under GCP, the FDA’s Clinical Research Review Process, and discussions on clinical research in Vietnam.

This workshop builds on the July, 2006 visit of  U.S. Secretary of Health and Human Services Michael Leavitt, and the agreement he signed with Vietnamese Minister of Health Tran Thi Trung Chien.  This Agreement on Health and Medical Sciences Cooperation Between the United States of America and the Government of the Socialist Republic of Vietnam formalized the relationship between the Department of Health and Human Services and the Ministry of Health and provides a framework for continued collaboration on many health-related issues.  This workshop is an example of cooperation under this new agreement.

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