Spring 2025

Design and implementation of a quality system assuring the quality and safety of pharmaceuticals and biologics, according to relevant FDA and international regulations and guidance documents.

Design of systems according to FDA and international regulations and guidelines to ensure the quality and safety of medical devices and combination products.

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.

Regulatory requirements governing medical products in European Union, Asia and other global markets.

Historical development, formal language and theoretical approaches to risk management in health care and medical product environment; policies, regulations, standards; liability prevention and loss control. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience. (Duplicates credit in MPTX 520.) 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.

Current problems in regulatory affairs, legal management, preclinical and clinical testing, scientific evaluation and quality assurance. (Duplicates credit in former MPTX 521.) Graded CR/NC. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post secondary training and industry experience; enrollment in MS Regulatory Science program.

Clinical designs and statistics commonly used to test medical products in general populations and special patient groups.

Examines the process of drug discovery from selection of disease and therapeutic target to characterization and validation of lead drug candidates. 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.

Survey of drug development strategies; health economics and outcomes researches and reimbursements; emphasis on coverage determination process and FDA and CMS parallel review process

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).

Special topics in Regulatory Science

Introduction to business principles appropriate to medical products, including: supply and demand, product entry-exit strategies, financing, reimbursement, marketing and pricing in global marketplace. 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.

Theory and methods to manage complex projects in medical products sectors; timelines, intellectual property, security, contracts, budgets, review activities, reports, electronic tools, cross-cultural communication. Recommended preparation: Undergraduate or professional degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

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