Today’s increased scrutiny of pharmaceutical and medical device companies has produced an urgent need for training opportunities in specialized areas among workers in government and industry.

To equip an army of professionals who are able to oversee the extensive and expanding safety and regulatory requirements of products, the USC School of Pharmacy’s Regulatory Science Program offers masters and doctoral degrees as well as a quartet of certificates, each addressing a specific area. The newest of these, launched this fall, is the Certificate in Preclinical Drug Development.

The preclinical drug development certificate provides advanced training for individuals interested in preclinical aspects of translational medicine and associated research. It is designed for graduate students as well as industry professionals who are moving innovative molecules from the bench to the bedside.

“We have added this new certificate program in response to today’s accelerated process of moving new therapeutics to the patient,” said Frances J. Richmond, director of the Regulatory Science Program. “Moving pharmaceuticals and medical devices along more quickly – making them available to patients in an expedited manner – also requires a more urgent, vigilant professional to address the attendant technical, ethical and regulatory requirements of the product.”

This new certificate, like the other three offered by the Regulatory Science Program, is accredited and requires 16 units for completion.

“Since many of our students are working professionals, we offer our classes on the weekends and via distance education,” Richmond said. “The distance option allows students to be part of the class via live streaming video or to view the archived class at a later time.”

Among the other programs is the Certificate in Patient and Product Safety that addresses safety and risk management in the health-care and health-product environment. This course prepares professionals to evaluate and mitigate medical errors and other safety problems in hospitals and other patient-care settings. It also educates those who will oversee drug and device safety before and after the products are sold.

Participants pursuing this certificate come not only from industry but also from the FDA, with whom the USC regulatory science program has a memorandum of agreement to train individuals in the Center for Drug Evaluation and Research. These FDA students take classes through distance learning technology.

Another program, the Certificate in Clinical Research Design and Management, strengthens the statistical, research and project-management skills of clinical researchers. Individuals interested in clinical research in either a clinical site or in a medical products company will find this certificate of particular benefit.

And lastly, the Certificate in Food Safety equips individuals with a functional toolkit for working in the production, management and regulation of food in industry and government. This certificate is geared for regulatory and safety professionals working in the food and supplement industries.

Certificate classes are open to students with a baccalaureate degree from an accredited college or university. For more information, visit the regulatory science Web site (regulatory.usc.edu) or contact the program coordinator at (323) 442-3531 or regsci@usc.edu.