CR014 Clinical Research Regulations and Good Clinical Practices (GCP)

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.

• + In Class Registration CAD$995 +HST
• In-Class