USC Schedule of Classes

Introduction to regulatory environments surrounding medical product development, manufacturing and marketing; operation of federal, state and international regulatory bodies. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

Ensuring safety and effectiveness of new drugs and biologics; marketing and monitoring approved pharmaceutical/biological products; management of genetically engineering products. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

Development and testing of new medical products according to U.S. and international regulatory requirements. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in M.S., Regulatory Science or departmental approval.

Regulation and testing of foods, food additives and dietary supplements in the U.S. and abroad. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

Principles of quality assurance and quality control for medical-product development and manufacture. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

Development and execution of clinical trials: bioethical principles, good clinical practices, project management and documentation.

Part-time or full-time, practical work experience in the student's field of study. The internship must be located at an off-campus facility. Students are individually supervised by faculty. May not be taken until the student has completed at least one semester of enrollment in the graduate program with a cumulative 3.0 GPA.

Research/policy analysis conducted under preceptor supervision in an industrial or governmental setting. Open to students who have completed the majority of course credits in the Regulatory Science program. Graded CR/NC.