Clarifying the Clinical Trial Process for Drugs and Biologics
Benjamin Zegarelli
Of Counsel
Mintz
(New York, NY)
- Overview of clinical trials and how they are used (including different phases)
- Identifying the different parties involved (sponsors, investigators, CROs, etc.)
- Understanding human research protection (ICF, IRB)
- Enforcement
- Review of the “Right to Try” laws and their requirements during the clinical trials process