Restricted Operations Due to Coronavirus Outbreak

For the safety of our community, UWPCE has restricted operations due to the coronavirus outbreak.

For more information, see our FAQ

Introduction to Biomedical Regulatory Affairs

collapse

Course Details

This course can only be taken as part of the Certificate in Biomedical Regulatory Affairs.

Get Program Details

About this Course


This course surveys government oversight of drugs, devices and biotechnology-derived products. We’ll examine the laws and regulations that apply to development, testing and production. You’ll explore the responsibilities of a regulatory affairs specialist in the regulatory setting.

What You'll Learn

  • The history and rationale of U.S. food and drug law, creation of the FDA and its current organization and responsibilities
  • Aspects of specific U.S. laws and regulations applicable to drugs, devices and biotechnology-derived products
  • Market clearance requirements and processes, including product classification, clinical studies, GLPs, GCPs, investigational product requirements (IND/IDE), and research clearance (IRB)
  • Clinical study design, implementation and monitoring
  • Issues related to product clearance [NDA/BLA, PMA, 510(k)]
  • Roles of a regulatory affairs specialist within an organization and with the FDA
  Stay up to date with emails featuring career tips, event invitations and program updates.       Sign Up Now