DEVELOPMENT AND REGULATION OF BIOPHARMACEUTICALS: Students will learn about topics such as Quality by Design, Good Lab Practice, Molecule Design by QbD, Vaccine Potency Testing, Design of Clinical Trials, Vaccine Regulation and Preclinical Studies, cGMP Manufacturing and Compliance, and COVID-19 Disease and Biopharmaceutical Approaches.
Upon completion of this course students will be able to demonstrate:
- An in-depth understanding of the history and current organization of the Food and Drug Administration (FDA), the development of the regulatory process, the history of key regulations and how to obtain FDA clearance to initiate clinical trials on new biotechnology products.
- An understanding of the process of biotechnology product development, including clinical stages and design of clinical trials and the various regulatory submissions.
- An understanding of the submission requirements supporting clinical trials. Guest speakers include staff from AstraZeneca, FDA, and Glaxo SmithKline.
