Clarifying the Clinical Trial Process for Drugs and Biologics

March 19, 2025 1:15pm

Heidi F. Gertner
Partner | Global Regulatory
Hogan Lovells

  • 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
  • Examining new FDA requirements for Diversity Actions Plans for clinical trials
  • Delving into the categories of meetings available both prior to filing an IND and at various stages throughout a clinical trial
    • What type of meeting can you get? (in-person/written response)
    • What should you submit?
    • How to prepare for it?