The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.| Advarra - Advancing Better Research
We recently welcomed Jan Hewett as our senior vice president, FDA regulatory advisor. With a decade of experience as regulatory counsel in the FDA’s Center for Drug Evaluation and Research – Office of Scientific Investigations, her experience will help Advarra’s clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research.| Advarra - Advancing Better Research