Courses of Instruction

USC School of Pharmacy

Courses

Regulatory Science

• RSCI 520 Introduction to Risk Management for Health Care Products

  Units: 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.
  Duplicates Credit in former MPTX 520.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 521 Seminars in Regulatory Science

  Units: 1
  Max Units: 6.0
  Terms Offered: FaSpSm

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  Current problems in regulatory affairs, legal management, preclinical and clinical testing, scientific evaluation and quality assurance.
  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.
  Duplicates Credit in former MPTX 521.
  Instruction Mode: Lecture
  Grading Option: Credit/No Credit
  
  
• RSCI 523 Advanced Concepts in Risk Management for Medical Products

  Units: 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.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 525 Introduction to Drug and Food Toxicology

  Units: 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.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 527 Medical Product Safety

  Units: 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.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 529 Application of Risk Management Tools and Techniques

  Units: 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.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 530 Translational Medicine: An Overview

  Units: 2
  Terms Offered: FaSpSm

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  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 MS, Regulatory Science, Certificate in Preclinical Drug Development and MS, Management of Drug Development.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 531 Industrial Approaches to Drug Discovery

  Units: 4
  Terms Offered: FaSpSm

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  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 MS, Regulatory Science, Certificate in Preclinical Drug Development and MS, Management of Drug Development.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 532 Early Stage Drug Development

  Units: 3
  Terms Offered: FaSpSm

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  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 MS, Regulatory Science, Certificate in Preclinical Drug Development and MS, Management of Drug Development.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 533 Safety Evaluation during Drug Development

  Units: 3
  Safety pharmacology/toxicology requirements mandated by FDA and other regulatory agencies to move a new chemical entity from discovery stage to market approval.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 534 Drug Development in CNS Disorders

  Units: 4
  Successes and challenges related to central nervous system therapeutics. Major brain disorders, current and future therapeutic targets and clinical trial designs.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 535 Methods Development and Validation

  Units: 3
  Foundation in the process of developing and validating analytical methodology for purposes of pharmaceutical, biological and medical device development.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 540 Analysis of Food and Dietary Supplement Regulations

  Units: 3
  Changes and interpretation of regulations affecting food supply and dietary supplements impacting global markets. Product development, health-claim positioning, advertising, media messaging, consumer choices, personal health outcomes.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 541 Drug Development, Reimbursement, and Marketing

  Units: 3
  Survey of drug development strategies; health economics and outcomes researches and reimbursements; emphasis on coverage determination process and FDA and CMS parallel review process.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 590 Directed Research

  Units: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
  Max Units: 12.0
  Terms Offered: FaSpSm

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  Research leading to the master’s degree. Maximum units which may be applied to the degree to be determined by the department.
  Instruction Mode: Lecture
  Grading Option: Credit/No Credit
  
  
• RSCI 596 Internship for Curricular Practical Training in Regulatory Science

  Units: 1
  Max Units: 4.0
  Terms Offered: FaSpSm

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  Part-time or full-time practical work experience in Regulatory Science. The internship must be located at an offcampus facility. Students are individually supervised by faculty.
  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).
  Instruction Mode: Lecture
  Grading Option: Credit/No Credit
  
  
• RSCI 601 Biomedical Commerce

  Units: 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 MS, Regulatory Science.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 603 Managing Complex Projects

  Units: 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.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 604 Regulatory Strategy in Asia

  Units: 4
  Terms Offered: FaSpSm

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  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 postsecondary training and industry experience.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 605 Managing Organizations and Human Resources

  Units: 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 postsecondary training and industry experience.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 606 Regulation of Emerging Technologies and Biological Products

  Units: 3
  Policies, testing and regulatory requirements affecting commercialization of biologics and novel medical technologies. Focus on biologics, blood and tissue products, radiopharmaceuticals and nanotechnology.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 607 Theory, Methods and Practice of Medical Products Research

  Units: 4
  Terms Offered: FaSpSm

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  Statistical and research design methods, data analysis, survey and interview techniques laying the foundation for the dissertation.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 608 Regulatory Strategy in Europe and the Americas

  Units: 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.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RSCI 790 Directed Research

  Units: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
  Max Units: 12.0
  Terms Offered: FaSpSm

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  Research leading to the doctorate. Maximum units which may be applied towards the degree to be determined by the department.
  Instruction Mode: Lecture
  Grading Option: Credit/No Credit
  
  
• RSCI 794a Doctoral Dissertation

  Units: 2
  Dissertation research required for completion of doctoral degree in regulatory science.
  Instruction Mode: Lecture
  Grading Option: In-progress to Credit/No Credit
  
  
• RSCI 794b Doctoral Dissertation

  Units: 2
  Dissertation research required for completion of doctoral degree in regulatory science.
  Instruction Mode: Lecture
  Grading Option: In-progress to Credit/No Credit
  
  
• RSCI 794c Doctoral Dissertation

  Units: 2
  Dissertation research required for completion of doctoral degree in regulatory science.
  Instruction Mode: Lecture
  Grading Option: In-progress to Credit/No Credit
  
  
• RSCI 794d Doctoral Dissertation

  Units: 2
  Dissertation research required for completion of doctoral degree in regulatory science.
  Instruction Mode: Lecture
  Grading Option: In-progress to Credit/No Credit
  
  
• RSCI 794z Doctoral Dissertation

  Units: 0
  Dissertation research required for completion of doctoral degree in regulatory science.
  Instruction Mode: Lecture
  Grading Option: In-progress & Credit/No Credit
  
  
• RSCI 800 Studies for the Qualifying Exam

  Units: 0
  Terms Offered: FaSpSm

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  Preparation for the qualifying exam.
  Instruction Mode: Lecture
  Grading Option: Credit/No Credit
  
  

Pharmaceutical and Regulatory Science

• RXRS 209 Mysterious Deaths: Poisons in Literature and History

  Units: 2
  Poisons as described in classical literature that shaped, modified or changed the course of history presented in the context of pharmacological/toxicological principles of drug action.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 402 Human Pharmacology: Challenge of Therapeutics in Society

  Units: 4
  Principles of human pharmacology/toxicology related to prescription, over the counter medications; nutraceuticals; drug-drug interactions; polypharmacy; hot topics related to recently approved drugs.
  Recommended Preparation: Students should have at completed at least one year of undergraduate biology and/or chemistry
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 403 Neuropharmacology in Health and Disease

  Units: 4
  Neuropharmacological treatments of brain disorders including neurodegenerative disorders, injury, and disease; influence of environment and experiences on neuroplasticity and brain development; drug discovery.
  Prerequisite: BISC 220Lg  
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 404 Neuroimmunity in Health and Disease

  Units: 2
  Social, psychological, economical, biological reasons associated with drug use/abuse; prevention strategies; Pharmacology and Pharmacotherapy successes/ challenges; current trends; case studies; roles of health care professionals.
  Recommended Preparation: background in or completion of a year of biological science course work
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 405 Pharmacology and Sociology of Drug Abuse

  Units: 4
  Social, psychological, economical, biological reasons associated with drug use/abuse; prevention strategies; pharmacology and pharmacotherapy successes/ challenges; current trends; case studies; roles of health care professionals.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 407 The Discovery, Development and Marketing of Medicines

  Units: 4
  Principles, concepts, challenges and short comings of modern day drug discovery and development of medicines. Inter-relationships with regulatory, ethical and societal sectors presented. 
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 411 Innovations in Medical Product Development

  Units: 4
  Developing new medical technologies; political, regulatory, financing and reimbursement issues that may be associated; case studies looking at the newest medical technologies.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 413 Globalization of the Biomedical Industry

  Units: 4
  Globalization; pharmaceuticals, biologics, medical devices, and combination products in advanced, emerging, and developing markets; regional and national regulations, global and regional harmonization efforts, ethical considerations.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 416 Medical Products: From Idea to Market

  Units: 4
  Progress of medical product development through intellectual property, animal and clinical trials  and commercialization. Emphasis on safety, quality systems and efficacy.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 417 Food Safety: The Good, The Bad and The Deadly

  Units: 4
  Critical thinking, science translation, effective communications, personal health, and public policy development are at the interface of food safety, nutrition intervention and health controversies.
  Instruction Mode: Lecture
  Grading Option: Letter
  
  
• RXRS 490x Directed Research

  Units: 1, 2, 3, 4, 5, 6, 7, 8
  Max Units: 12
  Individual research, reading, writing and project development.
  Not for Degree Credit
  Instruction Mode: Lecture
  Grading Option: Letter
  
  

Pharmaceutical and Translational Sciences

• PHTS 654 Computation in Drug Discovery and Development

  Units: 2
  Terms Offered: Fa

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  Focuses on computational prediction of molecular association and ADME (absorption, distribution, metabolism, excretion) properties in drug discovery and development.
  Recommended Preparation: Review basic computer skills
  Instruction Mode: Lecture, Lab, Discussion
  Grading Option: Credit/No Credit