Drug and Biologic Regulations

Catalog description

Drug and Biological medical products are among the most profitable, yet most demanding to commercialize, requiring the major regulatory oversight. This course will provide students with an in-depth understanding of relationships between scientific discovery, testing and regulatory oversight of drug and biological medical products. It will look at the practical issues and rules governing prescription and over-the-counter drugs, and look at the changes that being introduced by genetic engineering, generic and biological product development. This course will consider the issues facing regulatory specialists as they work with the FDA and other international regulatory bodies to secure and maintain product approval.