Clinical Trials and Quality Assurance

Catalog description

Three hours lecture per week Prerequisite(s): Admission to the Biotechnology & Bioinformatics, M.S. or the Biotechnology, M.S. & M.B.A. Dual Degree program Introduction to the foundational knowledge and skills necessary to successfully conduct clinical trials for new drugs, biologics, and medical devices, including in vitro diagnostics. Topics include a broad overview of the product development process in the pharmaceutical, biopharmaceutical, and medical device industries, the regulatory and operational requirements for clinical study setup and management, monitoring, data management, and closure of clinical trials, the principles of Good Clinical Practice (GCP), and the applications of quality control and quality assurance. The integration of quality assurance throughout the medical product development process will be discussed.