AHPA President Michael McGuffin on July 26 served as a guest lecturer at the University of Southern California (USC) School of Pharmacy's Regulatory Science Program. McGuffin's full-day presentation, "U.S. Regulatory Environment for Dietary Supplements," was part of the "Regulation of Foods and Dietary Supplements" course.
In his presentation, McGuffin addressed basic regulatory issues, such as dietary supplement ingredients and forms, good manufacturing practice (cGMP), new dietary ingredients, and adverse event reporting.
In addition to his role as a lecturer, McGuffin has been a member of the program's advisory board since its inception in 2001.
The USC Regulatory Science Program provides academic training in regulatory affairs, clinical research and quality systems. It includes a wide breadth of courses that address issues relevant to drugs, devices, foods, and dietary supplements and offers both Master of Science and doctoral tracks.
As recently as February 2011, Margaret Hamburg, M.D., commissioner of the Food and Drug Administration, published an editorial in the journal Science, in which she called for "a strong field of regulatory science to develop new tools, standards, and approaches" to ensure the safety and quality of food and drug products. Hamburg also noted that FDA may invest in academic settings focused on regulatory science research as resources allow.
"My primary goal in teaching this class and supporting the USC program is to ensure that some of its attention remains on the dietary supplement category," said McGuffin. "The emerging complexities in the regulation of the supplement industry create both a need for well-educated experts and opportunities for graduates in regulatory science."
Additional information on the USC School of Pharmacy's Regulatory Science Program can be found at its website.