Clarifying the Clinical Trial Process for Drugs and Biologics

March 22, 2023 1:30pm

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