Search Results

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

  • Schedule of Classes
  • All Course Descriptions
  • Co-op
  • Academic Advising
  • Admissions
  • Tuition & Fees