A total of 45 credits are required for graduation from the program. Credits should be acquired through the completion of the core or recommended program courses.
Courses designated with this sign will accept, on a space available basis, a limited number of professionals in the field who are not enrolled in the degree
Introduction to Biomedical Regulatory Affairs — PHARM 516 (3 credits)
Autumn Quarter 2009 (Tuesdays, 6–9 p.m., 10/6/09–12/8/09)
This course surveys government oversight of drugs, devices and biotechnology derived products; laws and regulations that apply to development, testing and production. It also addresses the responsibilities of a regulatory affairs specialist the regulatory setting.
Product Development and Manufacturing Systems — PHARM 517 (3 credits)
Winter Quarter 2010 (Tuesdays, 6–9 p.m., 1/5/10–3/9/10)
This course covers product development and manufacturing concerns (such as quality control, scale-up, good manufacturing practices (GMPs) and quality systems), the U.S. Food and Drug Administration inspection process, and FDA regulatory actions. The focus is on the QSIT (Quality System Inspection Technique).
Product Testing, Evaluation and Post-Market Issues — PHARM 518 (3 credits)
Spring Quarter 2010 (Tuesdays, 6–9 pm, 3/30/10–06/1/10)
This course focuses on post-marketing requirements, reporting and enforcement actions. Emphasis is placed on inspection (internal and by regulators), preparation, conduct and follow-up actions. Post-marketing 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, using knowledge gained in the course.
Introduction to Clinical Trials — PHRMRA 524 (3 credits)
Autumn Quarter 2009 (Mondays, 6–9pm, 10/5/09–12/7/09)
This course introduces the major concepts under which 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. The study design and statistical concepts are also addressed.
Implementation and Conduct of Clinical Trials — PHRMRA 525 (3 credits)
Winter Quarter 2010 (Mondays, 6–9pm, 1/4/10–3/22/10)
This course outlines the work of carrying out a clinical trial. The complex work of study initiation, the issues of site and data managements, the preparation of the final report and study close-out are covered, as well as the myriad details that control the study conduct.
Project Management and the Business of Clinical Trials — PHRMRA 526 (3 credits)
Spring Quarter 2010 (Mondays, 6–9 p.m., 4/5/10–6/14/10)
This course is designed to address the business dimension of clinical trials. Within the context of clinical trials that involve a large number of tasks and people responsible for parts of the overall study, the course addresses the principles of project management, planning, analysis, contingency and follow-up.
Technical Writing for the Medical Products Industries — PHRMRA 546 (3 credits)
(Saturdays, 10/3/09–112/7/09, 9 a.m.–2:30 p.m.)
Autumn Quarter 2009
The course presents up-to-date information and strategies for effective technical communication within the medical product industries. It addresses the appropriate and correct use of the English language, information design, and the use of computer technology in producing professional documents. It also emphasizes communicating technical information to a variety of stakeholders.
How to sign up for individual enrollment in this course
Statistical Basis of Quality Assurance for Regulated Industries — PHRMRA 545 (3 credits)
(Wednesdays, 3/31/10–6/2/10, 6– 9 p.m.)
Spring Quarter 2010
This course reinforces the vocabulary and major concepts in statistics, and introduces methods used in medical products industries regulated by the U.S. Food and Drug Administration. Prerequisite: Introductory statistics.
How to sign up for individual enrollment in this course
International Regulatory Affairs — PHRMRA 527 (3 credits) (Thursdays, 10/1/09–12/10/09, 6–9 p.m.)
Autumn Quarter 2009
The course content will focus on the regulatory processes of industrialized markets, but it is also designed to address evolving issues in emerging markets. By the end of the course, students should have a thorough understanding of the history behind international regulatory harmonization and the role this has played in solving current challenges and providing opportunities under the current climate of global trade and medical products regulation.
How to sign up for individual enrollment in this course
Medical Risk Analysis and Management — PHRMRA 528 (3 credits) (Thursdays, 1/7/10–3/11/10, 6–9 p.m.)
Winter Quarter 2010
Risk analysis, management and communication are increasingly important tools for medical products manufacturers both in the United States and internationally. Recent U.S. Food and Drug Administration and International Committee on Harmonization initiatives emphasize risk management in product development, manufacturing and marketing. This course will impart principles and applications of risk management methods in the design, manufacturing and marketing of medical products.
How to sign up for individual enrollment in this course
Advanced Topics in Medical Products Regulation — PHRMRA 547 (2–6 credits)
(Wednesdays — Starts Autumn Quarter 10/7/09 and Winter Quarter 1/6/10)
This course addresses essential topics in medical products regulation at an in-depth, advanced level. The course employs a combination of lecture presentations, case studies, and small-group discussion to achieve practical outcomes for regulation professionals. The course enhances competencies required to pass the Regulatory Affairs Professional Society Regulatory Affairs Certification (RAC).
Biomedical Regulatory Affairs Practicum (9 credits)
This course provides a practical experience to ensure that participants can shepherd new medical products (drug, device and biologic) through regulatory, clinical and quality assurance aspects. Students work on projects of their choice under the guidance of an adviser. They refine their work as they progress in the program and produce a final report. This is an independent study course, but students will be required to participate in group presentation sessions. These sessions provide an opportunity for students to share knowledge among peers, hone communication and presentation skills, and be evaluated by cohort members and instructors.
Waivers
All students must satisfy a minimum of 45 credits to graduate. Students who have completed either the UW Biomedical Regulatory Affairs or Clinical Trials certificates courses prior to entering the program may instead obtain academic credit by completing an independent study project, or one of the elective courses recommended by the program, for additional professional development.
Requests will be assessed on an individual basis by the program director. Requests for waivers or substitutions will not be granted for any other reason.