MIIM 573S Regulatory Affairs for Cell and Gene Therapy 1 3.0 Credits
Explores cell and gene regulatory affairs from pre-clinical IND-enabling studies to product licensure. The course is designed to introduce the historical basis for and continuing evolution of gene therapy regulations in response to patient safety events, emerging technologies, and product type. Content will be presented to educate students on the overall product development and approval process, including research and analysis methods, regulatory agency interactions, and the CTD (Common Technical Document) structure.
College/Department: COM School of Biomedical Sciences Professional Studies Repeat Status: Not repeatable for credit
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