Cheryl Grandinetti
Associate Director for Clinical Policy in the Office of Compliance at the U.S. FDA with a pharmacy background and long experience in clinical trial policy and inspections, who served as the FDA topic lead on ICH E6(R3).
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Jan 15, 2026 • 28min
ICH E6(R3): Shifting the Paradigm from Process to Purpose
Cheryl Grandinetti, FDA clinical policy leader with a pharmacy background, and Lisbeth Bregnhoj, Danish GCP inspector and pharmacist, talk ICH E6(R3) changes. They discuss the new data governance chapter and shifting from rigid processes to purpose-driven, risk-based trial design. Conversations cover defining Critical-to-Quality factors, harmonizing regional language, and reducing site burden while improving inspection alignment.
