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Introduction to Biomedical Regulatory Affairs


Course Details

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

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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
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