Course Descriptions

PHARM 516: Introduction to Biomedical Regulatory Affairs

Instructors: Tom Hazlet and Daina Graham
Credits: 3
This course surveys government oversight of drugs, devices and biotechnology-derived products and the laws and regulations that apply to their development, testing and production. It also addresses the responsibilities of a regulatory affairs specialist in the regulatory setting.

PHARM 517: Product Development & Manufacturing Systems

Instructors: Tom Hazlet and Daina Graham
Credits: 3
This course covers product development and manufacturing concerns, such as quality control, scale-up, good manufacturing practices. It also covers quality systems and the U.S. Food and Drug Administration inspection process and FDA regulatory actions. The focus is on the Quality System Inspection Technique, known as QSIT.

PHARM 518: Product Testing, Evaluation & Post-Market Issues

Instructors: Tom Hazlet and Daina Graham
Credits: 3
This course focuses on post-market requirements, reporting and enforcement actions. Emphasis is placed on inspection (internal and by regulators), preparation, conduct and follow-up actions. Post-market surveillance and studies and reimbursement and economics of pharmacology are discussed. As a final class project, students work in teams to design a regulatory strategy for a product.

PHRMRA 524: Introduction to Clinical Trials

Instructors: David Hammond, Eric Hayashi and Tracie Granger
Credits: 3
This course introduces the major concepts underlying how clinical trials are designed and run. It focuses on the phases of clinical trials, the role of the U.S. Food and Drug Administration, institutional review boards, the Code of Federal Regulations and ethical principles. Clinical study design and statistical concepts are also addressed.

PHRMRA 525: Implementation & Conduct of Clinical Trials

Instructors: David Hammond, Eric Hayashi and Tracie Granger
Credits: 3
This course outlines how to carry out a clinical trial. It covers the complex work of study initiation, issues of site and data management, preparation of the final report and study close-out as well as the myriad regulations that control how the study is conducted.

PHRMRA 526: Project Management & the Business of Clinical Trials

Instructors: David Hammond, Eric Hayashi and Tracie Granger
Credits: 3
This course addresses the business dimension of clinical trials. It covers 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.

PHRMRA 527: International Regulatory Affairs

Instructor: David Hammond
Credits: 3
This course 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.

PHRMRA 528: Medical Risk Analysis & Management

Instructor: Floyd Karp
Credits: 3
This course teaches the principles and applications of risk management methods in the design, manufacturing and marketing of medical products.

PHRMRA 536: Skills for the Regulatory Affairs Professional

Instructor: Lynn Rose
Credits: 2
This course covers the essential skills needed in regulatory affairs and includes an overview of local medical products companies.

PHRMRA 545: Statistical Topics for Biomedical Regulatory Affairs Professionals

Instructor: Keith Bower
Credits: 3
This course applies statistical techniques to meet medical product regulatory commitments including biosimilars, product comparability, design and continued process verification. Prerequisite: Introductory statistics.

PHRMRA 546: Technical Writing for Biomedical Regulatory Affairs

Instructor: Karen Teal
Credits: 3
This course presents up-to-date information and strategies for effective technical communication within the medical product industries. It addresses the proper use of the English language, information design and computer technology in producing professional documents. It also emphasizes how to communicate technical information to a variety of stakeholders.

PHRMRA 548: Biomedical Regulatory Affairs Practicum

Instructor: Jean Feagin
Credits: 9
This course provides a practical experience to ensure that participants can shepherd new medical products – drugs, devices and biologics – through regulatory, clinical and quality assurance processes. Students work on projects of their choice under the guidance of a preceptor at the practicum site. Each student plans a project with input from the preceptor, implements the plan and presents a final written report and oral presentation. Coordination and academic oversight is provided by the practicum director. Credit/no credit only.

This is an independent study course, with no required class sessions. The nine credits will be earned across a minimum of two quarters, with the pace of activities dependent the individual student and project.

PHRMRA 550: Advanced Technical Writing for Biomedical Regulatory Affairs

Instructor: Karen Teal
Credits: 2
This course further examines communications with attention to best writing practices. It provides an intensive review of common editing standards and advanced strategies for crafting accurate and effective documentation. Credit/no credit only.

PHARM 554: Advanced Medical Products Regulation I

Instructor: David Hammond
Credits: 2
This course provides an in-depth exploration of current regulatory issues related to medical product development.