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October 15, 2007
UW Responds to Rapid Growth of the Biotechnology Industry
Launches Professional Master's Degree in Biomedical Regulatory Affairs
Biotechnology's rapid growth in the Puget Sound region has cultivated a need for comprehensively trained personnel in fields related to the creation, development, regulation and manufacture of pharmaceutical and medical devices. To meet these needs, the University of Washington (UW) has developed the Professional Master of Science in Biomedical Regulatory Affairs.
Designed for working professionals, this new degree program begins in January 2008, and is scheduled for evenings and weekends. The new program bridges theory with practice. It is offered by the UW School of Pharmacy, nationally recognized as an innovative leader in pharmacy education, scholarship and research, in partnership with UW Educational Outreach.
Seattle is at the forefront of the biotech industry
Master's program with a comprehensive focus
Designed for working professionals
Bridging theory with practice
Taught by UW faculty and professionals in the industry
Professionals who will benefit from the program
About University of Washington Educational Outreach (UWEO)
Seattle is at the forefront of the biotech industry
Keeping the pulse of the regional and national economy, the UW began development of the new program as Seattle began to emerge at the forefront of the biotechnology industry. Today, more than 400 companies and organizations are members of the Washington Biotechnology and Biomedical Association (WBBA). According to the WBBA annual report, "The biotechnology and medical device industry in Washington directly employs nearly 20,000 people, with indirect employment exceeding 55,000."
Estimations have also put the number of clinical trials at any given moment in Washington State at around 4,000. Such an environment fosters biotechnology-related research, development and manufacturing supported by first-class educational institutions like the University of Washington, and makes Seattle an ideal place for professionals in the field.
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Master's program with a comprehensive focus
The UW Biomedical Regulatory Affairs program focuses on management aspects of taking a medical product-drug, device or biologic-from conceptualization to clinical trials to marketing, including post-marketing risk-management. It covers regulatory and quality assurance aspects, but also how to apply business and economic factors important to regulatory affairs for the pharmaceutical and medical device industries.
Designed for working professionals
Like other professional master's programs at the UW, the Biomedical Regulatory Affairs program is designed to meet the needs of working adults. Courses will be offered in evening hours and on weekends on the University of Washington campus in Seattle, at the UW Educational Outreach facility in Bellevue, and in other accessible locations. Requiring 45 credits for completion, the program's schedule allows participants to earn a master's degree within two years.
Also of importance to working professionals: the curriculum of the Biomedical Regulatory Affairs program is designed to bridge theory with practice. Its development has been guided by input of an advisory board whose members represent a cross-section of the professional community including representatives from the U.S. Food and Drug Administration, Fred Hutchinson Cancer Research Center, Sonus Pharmaceuticals, Medtronic Physio-Control, and Pacific Regional Laboratory Northwest.
Classroom-based courses will be augmented with a practicum that provides the on-the-job experience that is especially important for those entering the biotech industry from related fields. The program enjoys connections with a number of organizations and companies including Bayer HealthCare Pharmaceuticals, Amgen, Inc., Philips Medical Systems, AVI BioPharma, and SonoSite, Inc. that provide input on the needs of the professional community, information about job openings, opportunities for site visits, and internships for program enrollees. This insures a learning experience that is practical, real life, and cutting edge, with many networking opportunities in the industry.
Taught by UW faculty and professionals in the industry
Instructors for this professional master's degree include UW research and teaching faculty as well as affiliate faculty who are noted practitioners in the medical products industry. The participation of industry professionals ensures that students achieve competencies needed by the industry today and that they can be connected to key people and resources.
Led by Dr. Tom Hazlet, Associate Professor, UW Pharmacy, the instructional team includes the president of Drug and Device Development Co.; a senior project manager for Pharmaceutical Products Development, Inc. (PPD, Inc.); the president of the drug company, Ocularis, whose experience includes tenure with the National Institutes of Health and with the Food and Drug Administration's Division of Biopharmaceutics; and the president of LabConnect, a global provider of central laboratory services to the biopharmaceutical industry.
Professionals who will benefit from the program
Whether seeking career change or positioning themselves for advancement in their current field, professionals who will find this program of benefit include the following:
- Regulatory affairs staff members seeking a comprehensive view of the field, possibly for advancement
- Clinical trials staff in a pharmaceutical company, contract research organization, hospital and/or clinic
- Nurses seeking training for positions in the clinical trials field
- Professionals seeking employment with the Food and Drug Administration
- College graduates seeking entry into a field within or related to regulatory affairs
- Attorneys seeking a broad understanding of these fields in order to serve corporate clients with drug development, testing, manufacture and sales
- Pharmacists, physicians, scientists, and engineers interested in learning the fundamentals of regulatory affairs before entering into drug and device development and/or research
- Senior staff of a drug or device company or research institute seeking a supervisory or leadership role
About University of Washington Educational Outreach (UWEO)
UWEO is the continuing and professional education division of the University of Washington, the nationally recognized public research institution based in Seattle. Helping the schools, colleges, and departments to administer evening master's degrees, certificate programs, distance and online learning, international outreach and English language programs, and more, UWEO is one of the largest and most highly regarded continuing and professional education programs in the U.S.