This course covers the range of national and international regulations and guidances governing the development of drugs, diagnostics, medical devices, and biologics. Topics include a review of the regulatory agencies, guidelines for regulatory application, required documentation, and protection of human subjects. Upon completion, students should be able to demonstrate a basic understanding of regulations and guidelines associated with clinical research and describe effective means of compliance.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.
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