Clarifying the Clinical Trial Process for Drugs and Biologics
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?