Course Code: CLRE 5500
Academic Year: 2019-2020
This course focuses on medical products, devices and biologics. The first component will explore the approval of medical products and devices and associated clinical studies required by regulatory bodies. The course will also examine other industry influences that impact the development and use of medical products and devices. Students develop conceptual understanding of molecular genetics, protein chemistry, microbiology and immunology, as applied to medical devices and products, specifically in the field of medical biotechnology. Students will learn about recombinant DNA technology and genomics, which have application in drug development, pharmacogenomics, DNA-based diagnosis of genetic diseases, in human gene therapy, GMOs, etc. Furthermore, students will explore concepts underlying innate and adaptive immunity, which have applications in the development of vaccines for infectious diseases, in oncology, and transplantation. The current regulatory framework governing biotechnology industry in different countries will also be explored.