Non-Drug Products

Course Code

CLIN 5300

Academic Year

2016-2017

This course is designed to provide students with the basic concept in medical devices and biotechnology with a focus on medical biotechnology. During the Medical Devices module, the students will learn processes of applying for licenses for medical devices, obtaining certifications, submitting annual notifications, etc. In the Biotechnology module, the students will study the basic concepts in molecular genetics, protein chemistry, microbiology and immunology. The students will learn about recombinant DNA technology and genomics, which has application in drug development, pharmacogenomics, DNA-based diagnosis of genetic diseases and in human gene therapy. Also, students will learn the concepts underlying the innate and adaptive immunity, which has application in the development of vaccines for infectious diseases, in oncology, and transplantation. Current regulatory framework governing this industry in different countries will be explored by visiting related websites.