U.S. Food and Drug Administration Supports Ministry of Health Efforts to Enhance Good Clinical Practice Training Workshop in Vietnam

December 15, 2007

This morning, December 15, U.S. Ambassador Michael Michalak and Vice Minister of Health, Dr. Nguyen Thi Kim Tien, made opening remarks and welcomed Vietnamese participants to a training workshop on Good Clinical Practice.

Good Clinical Practice is a set of scientifically-based principles, which guide government regulators, physician-scientist investigators, and pharmaceutical sponsors in the conduct and oversight of clinical trials research and forms an essential part of the process to ensure the quality and safety of pharmaceutical and medical device products.  This 6-day training workshop from December 15–20 is the second step towards building the capacity of the Ministry of Health to conduct this type of training.

The Department of Science and Training of the Ministry of Health is organizing the workshop, with collaborative support from the Hanoi Medical University.  The U.S. Food and Drug Administration is providing financial support and has also sent a team of four experts, including two trainers, to provide technical assistance.