Certificate in Biomedical Regulatory Affairs
On This Page: Format | Courses | Cost | Credit/Noncredit Options | Admissions | How to Apply
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.
Format
This eight-month certificate program is offered in person on the UW campus in Seattle. Classes are held on weekdays in the evening.
Courses
You’ll take nine credits over three quarters.
Autumn Quarter
Instructors: Mohammad Shawish and Laurie Mendelson
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
Instructors: Mohammad Shawish and Laurie Mendelson
Credits: 3
This course covers product development and manufacturing concerns, such as quality control, scale-up and 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
Instructors: Mohammad Shawish and Laurie Mendelson
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
Cost
The Certificate in Clinical Trials costs $4,296 for the noncredit option and $8,766 for the credit option (2025–2026 academic year). Each quarter, students also pay registration ($55) and technology fees ($4–$22). Costs for textbooks and other course materials are extra.
Choose From Credit & 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.
Admissions
Application Deadline
We'll post information here soon about the next application cycle.
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. See guidance on proof of English language proficiency in How to Apply.
- 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
How to Apply
Before starting your application, prepare a current resume or CV that highlights your education and relevant professional experience and demonstrates how your background meets the program's admission requirements.
Before you begin your application, prepare a brief letter or personal statement (250 words maximum) that describes your relevant experience, transferable skills, knowledge of the field, and commitment to professional growth.
For those who need to provide proof of English language proficiency, please demonstrate that you meet these requirements:
- For the noncredit option: at least a B2 level of English language proficiency on the CEFR self-assessment grid
- For the credit option: an ability that meets UW’s English language proficiency requirement
Applications for this program are now closed. Check back here later this year when applications open to start the application process.
Complete your application online and submit all required materials.
All applications will be charged a $50 nonrefundable application fee. In one to two business days after submitting your application, you’ll get an email with a link to pay your fee.
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.