(BIOE 369) Advanced Topics in Regulatory Affairs

3 Credits

Regulatory requirements for the development and manufacture of 21st century medical products. Current challenges and innovative technologies in pharmaceuticals and medical devices. Topics include combination products, biosimilars, cell therapeutics, mobile medical applications, 3D-printed products, big data in healthcare, new approaches to process validation. Closed to students who have taken BIOE/ CHE 469 . Prerequisites: BIOE 225