Recall of Heparin, a widely used blood thinner, due to contaminants in shipments from in China …. Lead in paint on toys prompts massive toy recalls …. Wires used in implantable heart devices are defective and recalled by the manufacturer.

These are just a few recent headlines that have scared consumers, creating an uncertainty in the integrity of the foods we eat, the medicines we take and the medical devices we use.

In order to make products safer while following government regulations, USC announced the world’s first program leading to a professional doctorate in regulatory science at the 2008 Horizons Conference of the Regulatory Affairs Professional Society in San Francisco.

“The doctoral program is aimed at mid-career executives in the rapidly growing biomedical and pharmaceutical industries,” said Frances J. Richmond, the director of the program. “It will focus on global strategies for dealing with the explosion of new health care products and the web of national laws and international policies that govern everything from clinical trials to manufacturing and advertising.”

Richmond started the USC regulatory science program offering a Master of Science curriculum in 1999. At its inception, the USC program was one of only a handful in the nation, though today a dozen programs exist.

USC’s program has grown from a few students to nearly a hundred. The demand for the graduates has been startling, with many entertaining multiple job offers upon or before degree completion.

“Dr. Richmond has cultivated a rich network of industry partners, many of whom teach in the program and hire our graduates. These partners convinced us of the need to offer the professional doctorate,” said School of Pharmacy Dean R. Pete Vanderveen.

According to Richmond, regulatory science is transitioning from administering paperwork and procedures to pioneering new ways to manage the opportunities and challenges that have been the fodder of news headlines over the past years.

“The USC professional doctoral program in regulatory science represents a major milestone in recognizing the critical importance of regulatory affairs as a discipline requiring the highest level of formal scientific training,” said Rick Wilson, senior vice president of Global Regulatory Affairs at the pharmaceutical company Allergan.

“Just as the master’s program has produced critically needed talent for this important field, the doctoral program promises to increase the supply of well-trained, knowledgeable persons needed for industry, academia and regulatory agencies.”

Added Richmond, “Classes for students in the doctoral program will be offered at the USC Health Sciences campus and via distance education classes that provide a virtual classroom experience through lecture webcasting, live video-conferencing and ‘e-teams’ tackling simulated projects. The program structure has been designed to accommodate working professionals.”

The program is expected to take three to five years, depending on the student’s prior education and the amount of time available to devote to studies.

Each student’s studies will culminate with the development and defense of an original research thesis in an area at the forefront of this emerging new science. Recognizing the growing shortage of regulatory science professionals, it is anticipated that many companies will provide substantial support for students who enroll in the program.

Applications are currently being accepted for the inaugural class starting this fall.

For more information, contact regsci@usc.edu or Kathy Knodel, manager of regulatory science programs, at (323) 442-3102.