Courses of Instruction

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. (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.

RSCI 521 Seminars in Regulatory Science (1, max 6, 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 523 Advanced Concepts in Risk Management for Medical Products (3) Managing risk in demanding health-care and medical-product situations: clinical trials, emerging technologies, counterfeit prevention, hard-to-reach populations. 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 M.S. (Regulatory Science), Certificate in Patient and Product Safety, or permission of instructor.

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, FaSpSm) 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 and M.S., Management of Drug Development.

RSCI 531 Industrial Approaches to Drug Discovery (4, FaSpSm) 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 and M.S., Management of Drug Development.

RSCI 532 Early Stage Drug Development (3, FaSpSm) Explores the activities involved in transforming 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 and M.S., Management of Drug Development.

The units for this course have changed beginning fall 2012.

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RSCI 596 Internship for Curricular Practical Training in Regulatory Science (1, FaSpSm)
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 M.S. (Regulatory Science).

RSCI 596 Internship for Curricular Practical Training in Regulatory Science (1, max 4, FaSpSm) 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).

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.

RSCI 603 Managing Complex Projects (3) 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.

RSCI 604 Regulatory Strategy in Asia (4) 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. Prerequisite: MPTX 519; recommended preparation: undergraduate or professional degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

RSCI 605 Managing Organizations and Human Resources (3) Theory and practice of personnel management, organizational structure and industrial relations in small, growing enterprises and large global companies typical of pharmaceutical and medical device sectors. Recommended preparation: undergraduate or professional degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

RSCI 608 Regulatory Strategy in Europe and the Americas (4) 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.

RSCI 794abcdz Doctoral Dissertation (2-2-2-2-0) Dissertation research required for completion of doctoral degree in regulatory science. Graded IP/CR/NC.