“IND/IDE’s and Regulatory Pathways”
Description:
This seminar will cover the IND/IDE submission process, specifically focusing on:
- Investigator initiated IND/IDE
- Single patient (emergency use) IND/IDE
- Requirements after IND/IDE is approved for use
Speaker:
Darlene Kitterman, MBA
Director of UICC Clinical Trials Office
Competency Area:
#3: Medicine Development & Regulation