Spring 2016

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

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.

Factors affecting toxic responses to foods and drugs: dose-response relationships, absorption, distribution, biotransformation, elimination of toxicants; target organ toxicity, teratogenesis, mutagenesis, carcinogenesis, food allergies, risk assessment. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

Use of risk management tools in the medical products arena: functional analysis, fault-tree analysis, failure modes and effects analysis, HACCP and six sigma methods. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

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.

Foundation in the process of developing and validating analytical methodology for purposes of pharmaceutical, biological and medical device 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).

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.

Regulatory strategy in EU, Canada, Mexico and South America; culture, health-care practices, reimbursement, product registration, quality systems, trade restrictions, import/export requirements. Travel may be required. . 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 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