Regulatory Affairs for Cell and Gene Therapy

The Certificate in Regulatory Affairs for Cell and Gene Therapy trains leaders for this growing discipline and prepares them to bring new therapeutics to market. Students will learn how to manage everything from pre-clinical IND-enabling studies to product licensure, and on into post-approval lifecycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, ethics, CMC, and international market requirements for cell and gene regulatory affairs.

Online Program

Please refer to Drexel University Online for application requirements and deadlines.