Summer 2025

Introduction to regulatory environments surrounding medical product development, manufacturing and marketing; operation of federal, state and international regulatory bodies.

Ensuring safety and effectiveness of new drugs and biologics; marketing and monitoring approved pharmaceutical/biological products; management of genetically engineered products.

Development and testing of new medical products according to U.S. and international regulatory requirements.

Regulation and testing of foods, food additives and dietary supplements in the U.S. and abroad.

Principles of quality assurance and quality control for medical-product development and manufacture.

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

Explores the activities involved in transformin an early drug or biological candidate to a drug approved for marketing by regulatory authorities. 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, certificate in Preclinical Drug Development.

Research leading to the master's degree. Maximum units which may be applied to the degree to be determined by the department. Graded CR/NC.

Part-time or full-time practical work experience in Regulatory Science. The internship must be located at an off-campus facility. Students are individually supervised by faculty. Graded CR/NC. Recommended preparation: Undergraduate or professional degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in MS (Regulatory Science).

A discussion of the unique technological and philosophical issues that challenge modern scientists and a discernment of ethical responses to those challenges.

Research/policy analysis conducted under preceptor supervision in an industrial or governmental setting.

Research leading to the doctorate. Maximum units which may be applied towards the degree to be determined by the department. Graded CR/NC

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Preparation for the qualifying exam. Graded CR/NC