480. Pharmacoeconomics. (3 s.h.)

Reviews the economic methodologies employed to evaluate the cost effectiveness of drug therapy. Cost effectiveness will be examined in terms of outcome assessment and quality of life measurements. Explore the dynamic environment of health care and the process of drug product selection in the managed care environment.

481. Biotechnology: Bioprocess Basics. (3 s.h.)

Covers the major steps of the biotechnology process: preparation of media, fermentation, recovery, chromatography, and related purification processes. Consideration is given to regulatory and control aspects of these processes. Includes an introduction to basic biosciences (i.e. micro-biology, biochemistry, genetic engineering, etc.).

482. Pharmaceutical Marketing. (3 s.h.)

Describes marketing dynamics within the health care industry and the way in which pharmaceutical companies can better meet the changing needs of patients and managed care. Focuses on individual marketing techniques and stresses the development of multidisciplinary marketing teams. The product attributes discussed in the selling process will be efficacy, safety, cost effectiveness, compliance, and treatment outcomes.

484. Manufacturing Process Validation. (3 s.h.)

Exposes students to all aspects of validation, with the exception of sterilization and aseptic manufacturing process validation. FDA Guides and Guidelines, as well as the current emphasis on validation concerns by FDA as identified in 483 and Warning Letter observations, will be incorporated. Students expected to develop acceptable validation protocols and what constitutes an acceptable validation report.

486. Good Laboratory Practices. (3 s.h.)

Explores regulatory and quality assurance issues pertinent to pre-clinical safety research. Analyzes research study design and processes in the sciences of pharmacology, toxicology, carcinogenicity, and reproductive toxicology. Some time devoted to mutagenicity and pharmacokinetics. Studies discussed in the context of developing a safety profile and determining the potential risk to humans in subsequent clinical trials.

487. Good Manufacturing Practices. (3 s.h.)

Study of the Current Good Manufacturing Practices Regulations under the Food, Drug and Cosmetic Act for drugs and their implication for personnel, buildings, equipment and records; includes a study of pertinent legal decisions and regulatory actions.

494. Quality Audit. (3 s.h.)

Covers topics in Quality Assurance principles, audit organizations, audit types, audit presentation and reports, auditing procedures for GMPs, GCPs, and GLPs.

495. IND/NDA Submissions. (3 s.h.)

Covers the development of IND and NDA submission for FDA reviews.

497. Statistics for Clinical Trials. (3 s.h.)

Introduction to statistics plus special topics of interest in statistical evaluation of clinical trials. Assumes no previous courses in statistics.

498. Computer Validation. (3 s.h.)

Focuses on the application of computer validation concepts to computer systems operating within a pharmaceutical research and development environment. Presents the specific needs and responsibilities of the various regulatory requirements and guidelines (both domestic and international).

508. The Pharmaceutical Company. (1 s.h.)

Required of all QA/RA students who have little or no background in the pharmaceutical industry. Introduces pharmaceutical organization, structure, functions and regulatory processes. Gives students entering the QA/RA program a general overview of all facets of drug discovery, development, manufacturing, and marketing.

510. Environmental Law and Regulation (EPA). (3 s.h.)

Explores regulatory arena of the agricultural and chemical industries. Basic knowledge of environmental laws and regulations as well as the key federal agencies (e.g., EPA, NRC, USFWS) influencing the chemical industry. Interpret and understand the development, registration and manufacturing of EPA-related products such as pesticides. Develop an appreciation of the global impact of pesticide regulation and examine registration requirements for international quality assurance (e.g., EU/OECD, JMAFF). Discussions of many well-publicized controversies such as Proposition 65 in California, Rachel Carson’s Silent Spring, federal ground water regulation, and the use of hormones in animal food. Field trip included.

533. Requirements for Product Labeling and Drug Information. (3 s.h.)

Examines strategies for creating drug labeling during new product development, for updating existing product labeling, and for creating "harmonized" core data sheets for products marketed globally. Insight and awareness of current trends in advertising and promotional regulation.

536. Good Clinical Practices. (3 s.h.)

Examines federal regulatory requirements and processes necessary to conduct valid drug trials on human volunteers. Emphasis placed on managing the clinical drug study and auditing its processes and generated data. Addresses ethical issues and volunteer informed consent.

537. Good Clinical Practices for CROs. (3 s.h.)

The study coordinator assisting the principal investigator of a clinical trial has a critical role in its success. Exposes research practitioners to a broad spectrum of clinical research topics and provides an in-depth understanding of the pharmaceutical industry. Examines the clinical research process from a regulatory and procedural basis and addresses the following: project management, effective site management techniques, monitoring, ethical considerations for the protection of human subjects and the quality of data.

586. Global CMC Issues & the Regulatory Dossier. (3 s.h.)

Provides students with an in-depth knowledge of the major chemistry, manufacturing, and controls (CMC) issues facing the global pharmaceutical industry. Develops the practical and theoretical skills necessary to develop successful CMC dossiers from the initial clinical application through marketing and post-marketing support. Emphasizes the importance of long range CMC prospective combining technical and regulatory knowledge with strategic thinking. Designed for regulatory professionals, managers, and scientists who have significant responsibility for the CMC dossiers.

591. International Drug Regulatory Systems.
(3 s.h.)

Provides a detailed analysis of the regulatory processes for new drug approvals outside of North America. Experience in comparing the European and Japanese registration trends with those of the United States. Future regulatory structures in the major world markets will also be explored.

592. Food and Drug Law I. (3 s.h.)

Governance of intrastate and interstate commerce in foods, drugs, cosmetics, and medical devices, and the effects of the Federal Food, Drug and Cosmetic Act upon research, manufacture, marketing, and distribution of drugs.

599. Clinical Aspects of Pharmaceutical Medicine I. (3 s.h.)

Designed to offer students a basic understanding of the disease processes most prevalent in our western culture. Appreciation for the epidemiology and demographic patterns of disease and the societal and economic impact of these diseases. Understanding of the etiology and pathophysiology underlying the disease processes and the role of pharmacologic intervention in the modification.

602. Clinical Aspects of Pharmaceutical Medicine II. (3 s.h.)

Prerequisite: Pharmaceutics 599 or permission of instructor.

Building on knowledge gained in Pharmaceutics 599, students will study additional key areas of clinical medicine and scientific topics, such as genetics, gastroenterology, obstetrics and gynecology, medical ethics, hematology, and emergency medicine. Includes new issues and updates in specialties such as cardiology and oncology.

605. Food and Drug Law II. (3 s.h.)

Prerequisite: Pharmaceutics 592 or permission of instructor.

Develops the regulatory concepts covered in the introductory course and establishes a framework for policy formulation and regulatory problem solving. Addresses the interpretation and implementation of policies which control the discovery, development, production and marketing of pharmaceuticals.

987. Special Problems in QA/RA. (4 s.h.)

Laboratory research or independent study of special pharmaceutical problems. Note: Students who do not take Pharmaceutics 987 must register for two (2) additional (3 s.h.) Pharmaceutical electives.

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