MIIM 574S Regulatory Affairs for Cell and Gene Therapy 2 3.0 Credits
Explores cell and gene regulatory affairs from product licensure and into post-approval life cycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, and international market requirements for cell and gene regulatory affairs. Specific focus will be on developing skills in formulating regulatory strategies from a scientific, risk-based approach by exploring hypothetical scenarios a regulatory affairs professional may encounter.
Repeat Status: Not repeatable for credit
Prerequisites: MIIM 573S [Min Grade: B]