PDF reflects print Regulatory Science (RSCI)
RSCI 520 Introduction to Risk Management for Health Care Products (2) 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.
RSCI 521 Seminars in Regulatory Science (1, max 3, FaSpSm) 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 M.S., Regulatory Science program.
RSCI 525 Introduction to Drug and Food Toxicology (3) 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.
RSCI 527 Medical Product Safety (3) Management of medical product safety by manufacturers/suppliers. Including: safe manufacturing, 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.
RSCI 528 Safety in the Health Care Environment (3) Regulatory expectations for health care facilities and services: JCAHO certification, environmental risk management, management of medical and medication errors, reduction of health hazards. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.
RSCI 529 Application of Risk Management Tools and Techniques (2) 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.
RSCI 530 Translational Medicine: An Overview (2) 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.
RSCI 531 Drug Discovery (4) 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.
RSCI 532 Early Stage Drug Development (3) Explores the activities involved in transforming an early drug or biological candidate to a drug approved for marketing by regulatory authorities. RRecommended 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.
RSCI 601 Biomedical Commerce (4) 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.