Understand How Drugs, Biologics and Devices Are Developed and Approved
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Regulatory affairs specialists play a vital role in the health care landscape, bridging the legal, business and scientific aspects of developing new biomedical products. This innovative field offers growing career opportunities and the chance to help improve people’s lives.
In this three-course certificate program, you’ll learn about the role of a biomedical products regulatory affairs specialist and the dynamic nature of the field. We’ll explore the regulatory jurisdiction of the U.S. Food and Drug Administration (FDA). You’ll delve into the laws and regulations that apply to the design, development, testing and production of biomedical products, including biologics, drugs, biotechnology-derived therapeutics, vaccines and medical devices. We’ll also examine post-market issues and requirements.
Professionals who want to enter or advance in the biomedical regulatory affairs field, or those who want to better understand the subject.
A bachelor’s degree is required. Work experience in the biomedical or related industries is preferred. Although previous experience in regulatory affairs is not required, those who are entirely new to the field will find this program more challenging. Students must be comfortable making periodic presentations in class.
If you're a non-native English speaker, you'll need a minimum TOEFL score of 100 and a subscore of at least 26 on the Listening section.
To enroll in this program, international students must have a visa that permits study in the United States. This program does not enable students to obtain or maintain F-1 visa status. For more information, see Admission Requirements for International Students.
You must have access to a computer, and we recommend a high-speed Internet connection.
You earn the certificate by regularly attending class and successfully completing all required courses. For more information, see Completing Your Program.
By completing this certificate program, you can earn up to 9 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. If you don’t plan to pursue a graduate degree, choose the noncredit offering. See Noncredit & Credit Options.
Complete the courses listed below to earn the certificate. You may be able to take individual courses without enrolling in the certificate program; check the course pages for details.
Introduction to Biomedical Regulatory Affairs
Product Development & Manufacturing Systems
Product Testing, Evaluation & Post-Market Issues
Certificate in Biomedical Regulatory Affairs
Approved by the UW School of Pharmacy and the UW School of Law.
With the exception of the one-time application fee, certificate program fees are charged on a quarterly basis. Payment is due when you register.
Course fees do not include any costs for class materials such as textbooks and software.
Drops, Withdrawals & Refunds
Course fees do not include any costs for class materials such as textbooks and software. The technology fee is based on the number of credits you are taking. It is not charged during summer quarter.
Attend class in person at one of our convenient locations. You’ll engage face to face with your classmates and instructors as part of a highly interactive curriculum. An online learning management system may be required to access some course materials and assignments.
Our special blended programs combine the convenience of online study with the vibrancy of in-person classes for a unique learning experience.
Not available for this program
Enjoy the flexibility of online learning, which allows you to participate in class activities, assignments and discussions on your schedule, from anywhere. Experience cutting-edge technology and a supportive, diverse learning community.
Associate Professor, Department of Pharmacy, University of Washington
Director, Master of Science in Biomedical Regulatory Affairs, University of Washington
Explore the key skills needed for project management within the biotech environment from a clinical, technical and regulatory perspective.
Develop a thorough understanding of the fundamental concepts and principles that guide the design and implementation of different types of clinical trials.
Learn the key aspects of taking a medical product — drug, device or biologic — from concept to market, including clinical trials and post-marketing surveillance.