Schedule of Classes

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.

Management of medical product safety by manufacturers/suppliers, including: safe manufcturing, labeling, packaging; pharmacovigilance, field observations, complaint handling; record keeping, safety issues documentation; crisis management/recalls. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

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.

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.