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.
College/Department: COM School of Biomedical Sciences Professional Studies Repeat Status: Not repeatable for credit
Prerequisites: MIIM 573S [Min Grade: B]
In order to graduate, all students must pass three writing-intensive courses after their freshman year. Two writing-intensive courses must be in a student's major. The third can be in any discipline. Students are advised to take one writing-intensive class each year, beginning with the sophomore year, and to avoid “clustering” these courses near the end of their matriculation. Transfer students need to meet with an academic advisor to review the number of writing-intensive courses required to graduate.
For additional information, and an up-to-date list of the writing-intensive courses being offered, students should check the Drexel University Writing Center page