Fall 2017

Audit requirements mandated by the FDA and other international regulatory agencies, including internal, external, regulatory agency, third party, GMP, GLP, ISO 13485/QSR and supplier audits.

Fundamentals and applications of Statistical Process Control (SPC) in development and monitoring of manufacturing processes; includes SPC in root cause analysis and CAPA.

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.

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.

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).

Regulatory policy, standards and practices in different Asian markets: product licensing, import/export management, materials sourcing, quality systems compliance, reimbursement, prescribing practices. 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.

Policies, testing and regulatory requirements affecting commercialization of biologics and novel medical technologies. Focus on biologics, blood and tissue products, radiopharmaceuticals and nanotechnology

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