REG 6320
Advanced Regulatory Topics for Biologics

The innovation in the Biotechnological and Biologics fields is advancing at a rapid pace. It is expected that many novel therapies in the fields of Immuno-oncology, Gene Therapy; Rare disease therapies will be approved for the treatment of various diseases. Also, it is expected that many new Biosimilar products will be introduced to the marketplace. The Regulatory authorities are challenged to keep pace with the innovations and providence guidance documents to the industry. Persons knowledgeable in the emerging therapies are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the regulatory and quality considerations of these emerging therapies. Through a series of lectures this course will teach the critical thinking and judgement skills that are needed for developing regulatory strategies for emerging therapies. (MEB 409)

REG 5310