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PHRMRA 524 Introduction to Clinical Trials (3)
Introduces the major concepts under which clinical trials are designed to run. Focuses on the phases of clinical trials, the role of the Food and Drug Administration, Institutional Review Boards, the Code of Federal Regulations and ethical principles. Addresses study design and statistical concepts. Offered: A.

PHRMRA 525 Implementation and Conduct of Clinical Trials (3)
Outlines the work of carrying out a clinical trial including the complex work of study initiation, issues of site and data managements, preparation of the final report and study close out, as well as the details that control the study conduct. Offered: W.

PHRMRA 526 Project Management and the Business of Clinical Trials (3)
Addresses the business dimension of clinical trials, including the principles of project management, planning, analysis, contingency and follow-up within the context of clinical trials that involve a large number of tasks and people responsible for parts of the overall study. Offered: Sp.

PHRMRA 527 International Regulatory Affairs (3)
Develops an understanding of international differences in the regulation of design, manufacture, and post-marketing surveillance of medical products relative to U.S. Food and Drug Administration requirements. Prerequisite: PHARM 504. Offered: A.

PHRMRA 528 Medical Risk Analysis and Management (3)
Examines the principles and application of risk management methods in the design, manufacture, and marketing of medical products. Offered: A.

PHRMRA 536 Skills for the Regulatory Affairs Professional (2)
Covers essential skills in regulatory affairs and includes an overview of local medical products companies. Offered: A.

PHRMRA 545 Statistical Topics for Biomedical Regulatory Affairs Professionals (3)
Applies statistical techniques to meet medical product regulatory commitments including biosimilars, product comparability, design and continued process verification. Prerequisite: introductory statistics. Offered: W.

PHRMRA 546 Technical Writing for the Medical Products Industries (3)
Presents up-to-date information and strategies for effective technical communication within the medical product industries. Addresses the appropriate and correct use of the English language, information design, and the use of computer technology in producing professional documents. Emphasizes communicating technical information to a variety of stakeholders. Offered: A.

PHRMRA 548 Biomedical Regulatory Affairs Practicum ([1-9]-, max. 9)
Provides a practical experience to ensure that participants are able to shepherd new medical products (drug, device, biologic) through regulatory, clinical, and quality assurance aspects. Includes a project and final report. Offered: AWSpS.

PHRMRA 550 Advanced Technical Writing for Biomedical Regulatory Affairs (2)
Further examines communications with attention to best written practices. Provides an intensive review of common editing and advanced strategies for crafting highly reliable and effective documentation. Prerequisite: PHRMRA 546 or permission of instructor. Credit/no-credit only. Offered: Sp.

PHRMRA 554 Advanced Medical Products Regulation I (2)
Provides an in-depth exploration of regulatory issues primarily related to non-clinical and clinical aspects of medical product development. Offered: W.

PHRMRA 560 Short Course in Multinational Biomedical Regulatory Affairs (2, max. 30)
Presents three medical products registration countries or groupings (for instance, European Union, World Health Organization). Locale based on program impact, unique features, or recent or controversial regulatory issues.

PHRMRA 595 Special Topics in Regulation (1-6, max. 24)
Offered: AWSpS.