Applied Regulatory Processes of Vaccines and Biologics

1 Course Unit

Drug development is at a turning point in human medicine. Over the past three decades, the development of biotherapeutics has revolutionized innovation in medicines. Efficiency and Quality Compliance are critical to achieving innovation and affordability. This course will provide an overview of the multi-dimensional nature of drug development, which involves regulatory, new technologies, statistical, and quality considerations. This course, which starts with a role-play exercise in developing a drug, will introduce the concepts which include pharmacology, toxicology, product development, clinical trials. All of these topics will be addressed based on regulatory requirements by the FDA. Risk assessment and mitigation will be discussed using discussion boards, case studies, and some invited guests. The content of the course includes seminars, case studies, project reports, and journal article reviews. In addition to the regulatory processes, the course also includes a discussion on soft-skill development such as decision making, scientific eminence, organizational structures, etc. Summer Term 1 Course Unit