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Master of Science in Biomedical Regulatory Affairs

Certificate in Biomedical Regulatory Affairs

On This Page: Format | Courses | Cost | Credit/Noncredit Options | Admissions

Gain the knowledge you need to work in an innovative industry and help shepherd new biomedical products through the various regulatory stages.

In this three-course certificate program, you’ll learn about the role of regulatory oversight in product design, development and manufacturing. We’ll cover the history of U.S. drug and medical device regulation and the jurisdictional scope of the FDA, including its inspection process and regulatory procedures. You’ll visit local companies to learn about good manufacturing practices and participate in group projects to gain in-depth experience in a variety of regulatory areas.


This eight-month certificate program is offered in person on the UW campus in Seattle. Classes are held on weekdays in the evening.


You’ll take nine credits over three quarters.

Autumn Quarter

Introduction to Biomedical Regulatory Affairs

Instructors: Joshua Kim
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. 

Credit course number: PHARM 516
Noncredit course number: REG AFF 110

Winter Quarter

Product Development & Manufacturing Systems

Instructors: Joshua Kim
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. 

Credit course number: PHARM 517
Noncredit course number: REF AFF 120

Spring Quarter

Product Testing, Evaluation & Post-Market Issues

Instructors: Joshua Kim
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. 

Credit course number: PHARM 518
Noncredit course number REG AFF 130


The Certificate in Clinical Trials costs $4,212 for the noncredit option and $8,595 for the credit option (2024–25). Each quarter, students also pay registration ($55) and technology fees ($4–$22). Costs for textbooks and other course materials are extra.

Choose From Credit and Noncredit Options

By completing this certificate program, you can earn up to nine credits toward degree requirements should you later be accepted into the Master of Science in Biomedical Regulatory Affairs. To use these credits, you must enroll in the credit version of the certificate program and obtain graduate nonmatriculated status before you register for the first course. The certificate also has a noncredit option if you don’t plan to pursue a graduate degree. For instructions on how to apply for GNM status, see the GNM section on the Admissions page. 


Application Deadline 

This program begins on October 1, 2024. We're accepting applications until 5 p.m. (Pacific Time) on September 17, 2024. We’ll consider applications received after that date if space is available.   

Admission Requirements 

  • Bachelor’s degree
  • Work experience in the biomedical or related industries (preferred; previous work experience isn’t required, but those who are new to the field may find this program more challenging)
  • Ability to make periodic presentations in class and work with fellow students on team projects
  • Intermediate English skills if English isn’t your native language
  • For international students, a visa that permits study in the United States (this program doesn’t enable students to obtain or maintain F-1 visa status)
  • Access to a computer with a high-speed internet connection  

Application Steps 

Step 1: Gather the following materials 

  • A brief letter (250-word maximum) that describes your relevant experience, transferable skills, knowledge of the field and commitment to professional growth 
  • A resume that highlights how your education and any applicable experience fulfill the program's admission requirements 
  • Proof of English language proficiency for those who need to provide it

Step 2: Apply 

Complete your application and submit the materials listed in step 1.

Pay the $50 nonrefundable application fee. In one to two business days after you submit your application, you’ll receive an email with a link to pay your fee.

Apply – Noncredit 

Apply – Credit 

After Applying

We’ll contact you within two weeks of receiving your application materials to let you know if you’ve been accepted to the program.

If you’re accepted, we’ll send you details about your first-term course, including information on how to register and pay your course fees. To ensure your spot in class, we recommend that you register by the priority registration deadline, which is four weeks before class begins. After that time, we may release your seat to another student. The final registration deadline is two days before the first class meeting.