Schedule of Classes

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.) 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.

An overview of principles and concepts underlying drug discovery and development, including terminology of translational science. 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.

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.