Courses

This course covers the range of national and international regulations 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 preparation for compliance audits. Upon completion, students should be able to demonstrate a basic understanding of regulatory processes associated with clinical research and describe effective means of compliance.

* The following courses must be completed prior to taking this course., Must complete CTR-110 with minimum grade C