January 22, 2014

IOM Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries

Dr. Andy Stergachis, a professor in the University of Washington’s School of Public Health’s departments of epidemiology and global health, has been named to the Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries.

The FDA requested that the Institute of Medicine convene a consensus study to assist FDA in identifying the core elements of needed pharmaceutical, biologics, medical device, and food safety regulatory systems development in developing countries; and in prioritizing these needs and recommending a strategic approach to FDA’s moving forward to address regulatory capacity needs in the context of globalization.  In addition to identifying and prioritizing the core elements of regulatory systems development, the consensus study will also identify potential areas in which progress could be made in a 3-5 year time frame; priorities for FDA engagement; areas to which others are best suited to contribute; and how FDA might best partner with these other institutions.

Dr. Stergachis earned a bachelor’s of pharmacy degree from Washington State University and an MS and PhD from the University of Minnesota.  He directs the University of Washington’s Global Medicines Program and serves as an adjunct professor of pharmacy and of health services.

Link to the Project on the IOM Web site: http://www.iom.edu/Activities/Global/RegulatoryCoreElements.aspx