Courses

Students in the part-time option complete 14 courses, for a total of 45 credits. In addition to that same coursework, students in the full-time option take at least seven additional credits of electives of their choosing, for a minimum of 52 credits.

Both part-time and full-time students participate in a nine-credit practicum, a hands-on experience in regulatory affairs at a Seattle-area company or institution.

Course Sequence

In addition to the core coursework below, students in the full-time, applied option take at least one to three additional credits of electives per quarter.

Year One

Autumn

PHARM 516: Introduction to Biomedical Regulatory Affairs
PHRMRA 524: Introduction to Clinical Trials
PHRMRA 536: Skills for the Regulatory Affairs Professional

Winter

PHARM 517: Product Development & Manufacturing Systems
PHRMRA 525: Implementation & Conduct of Clinical Trials
PHRMRA 546: Technical Writing for Biomedical Regulatory Affairs

Spring

PHARM 518: Product Testing, Evaluation & Post-Market Issues
PHRMRA 526: Project Management & the Business of Clinical Trials
PHRMRA 550: Advanced Technical Writing for Biomedical Regulatory Affairs

Summer (Optional)

PHRMRA 548: Practicum

Year Two

Autumn

PHRMRA 527: International Regulatory Affairs
PHRMRA 528: Medical Risk Analysis & Management
PHRMRA 548: Practicum

Winter

PHRMRA 545: Statistical Topics for Biomedical Regulatory Affairs Professionals
PHRMRA 548: Practicum
PHRMRA 554: Advanced Medical Products Regulation I

Spring

PHRMRA 548: Practicum