Biologics and Biotechnology products are becoming a major part of the pharmaceutical and bio pharmaceutical industry today. These products include food, pharmaceuticals, test kits, and combined products. They have different international and local regulatory requirements for their approval from the regulatory agencies. This course provides details of biological drug product development and the international and local regulatory requirements for successful submissions. In addition, several topics regarding biotechnology will be covered in this course that includes gene therapy in cells coming from plants, insects, or mammalians using viral and bacterial vectors, and industrial technology for producing vaccines.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Regulatory Affairs Departments.