Med Product Safety Regulations

Catalog description

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.