Courses & Curriculum


Degree Requirements

To earn the Master of Science in Biomedical Regulatory Affairs, you must successfully complete a minimum of 45 credits, including the 9-credit practicum.

Curriculum

The curriculum spans the process of taking a medical product – drug, device or biologic – from research and development to market and post-market. Instructors cover topics such as clinical trials management, product testing, risk management, technical writing and international regulatory affairs.

Students take a sequence of 14 courses, including the practicum, over a two-year, or six-quarter, period. All courses are required; there are no electives.

Course Sequence

Practicum

In the practicum, students get valuable hands-on experience shepherding a new medical product through aspects of the regulatory affairs process at a Seattle-area company or institution. Most students identify their practicum site through individual interests and networking, though placement assistance is available.

Students spend at least two quarters on their practicum, working on a project of their choice under the guidance of an on-site preceptor and the practicum director.

At the end of their practicum, students produce a final report and presentation for instructors and the rest of their cohort.


The writing classes were really helpful to me because English is not my first language. In the regulatory industry, there’s a lot of writing involved. So I can definitely say those classes helped me a lot, and I use what I learned every day.

Sudipta Chakrabahti
2012 Graduate

Regulatory Compliance Specialist, FUJIFILM SonoSite

[In industry practicums] students provide assistance to manufacturers and sometimes recalibrate the manufacturer's thinking...We have an outstanding reputation for capable students and
graduates.

Tom Hazlet
Associate Professor and Director, BRAMS