Certificate in Biomedical Regulatory Affairs

Approved by the UW School of Pharmacy and the UW School of Law 

Certificates » Biomedical Regulatory Affairs
Program Features
  • Option to take for noncredit CEUs or for graduate credit that can be applied to the Master of Science in Biomedical Regulatory Affairs 
  • Class field trips to local companies to learn about Good Manufacturing Processes
  • Optional participation in a special group project that involves conducting a structured policy analysis of an existing law, statute or regulation
Who Should Apply
  • Individuals who seek to expanded their understanding of regulatory affairs for the drug and medical device industry
  • Individuals who want to enter or advance in the biomedical regulatory affairs field
Understand the role of a medical products regulatory affairs specialist and the dynamic nature of the regulatory field. Study the regulatory jurisdiction of the U.S. Food and Drug Administration. Learn the laws and regulations that apply to the development, testing and production of medical products, including biologics, drugs, biotechnology-derived therapeutics, vaccines and medical devices. Explore post-market issues and requirements such as inspections, reporting and enforcement.
Key Outcome
You will know how to prepare the documentation and execute the processes necessary for FDA filings leading to the approval of pharmaceutical agents or medical devices.
Sections
Start Location Program ID Status
Autumn 2014  Details Details UW Seattle 4635 In Development
Autumn 2013  Details Details UW Seattle 4291 Closed
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Contact us or call 888-469-6499