Clarifying the Clinical Trials Process for Drugs and Biologics
ACI's 40th FDA Boot Camp
Mar
22
2023
Date: March 22, 2023
Time: 1:30PM - 2:30PM (EST)
Location: Virtual Conference
Mintz Of Counsel Ben Zegarelli will be speaking at the American Conference Institute's 40th FDA Boot Camp, leading the session "Clarifying the Clinical Trials Process for Drugs and Biologics". The session will cover the following:
- 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
Speakers
Benjamin M. Zegarelli
Speaker
Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.