Course Catalog

This course provides a comprehensive introduction to medical product safety and pharmacovigilance. Topics include an overview of the key components of product safety, product safety terminology, the processes for monitoring product safety, and the regulations that govern product safety and pharmacovigilance. Upon completion, students should be able to describe the processes for monitoring the safety of drugs, diagnostics, medical devices, and biologics throughout a product's life cycle.

This course provides an overview of national and global regulations governing the safety of medical products including drugs, diagnostics, medical devices, and biologics. Topics include a review of the regulatory agencies; regulations for pre-clinical, clinical, and post-market production safety; and regulations governing the process for monitoring product safety. Upon completion, students should be able to demonstrate a basic understanding of regulatory processes associated with clinical research and describe effective means of compliance.