Course Description
This course teaches path-to-market concepts including regulatory aspects unique to medical devices and pharmaceuticals. Topics include detailed analyses of Phase I-IV clinical trials, 510(k) and PMA approvals, Investigational Device Exemption (IDE) Investigational New Drug (IND) application, Good Laboratory Practices (GLP) and clinical research organizations (CROs). Students will participate in frequent visits to local biotech companies. Guest lectures will feature experts in FDA processes, clinical research and early stage biotech ventures.
Non-Std Tm
Through Fall 2022
Fall 2022
Instructors
Meeting Patterns
Classes Start:
August 22, 2022
Classes End:
December 5, 2022
Location:
01212 Engineering Building 2
Class Days:
T
Class Start Time:
5:30pm
Class End Time:
8:30pm
Class Type:
Lecture and Lab
Credits:
4.00
Restrictions:
Prerequisite: Graduate Standing; R: Restricted to students enrolled in the M.S. Biomedical Engineering Program