Episode 28: What is New With ICH E6 (R3)?

In this episode, Mélanie Pomerleau, Vice President of Quality and Compliance at Indero, joins us to explore the upcoming ICH E6 (R3) guideline revision. With over 25 years in the pharmaceutical and biotech industries, Mélanie shares expert insights on key changes, including the restructured document format, modernized GCP principles, enhanced patient centricity, and the integration of decentralized and adaptive trial designs. We also discuss evolving regulatory expectations, audit trends, and the growing importance of data governance. Tune in to understand how sponsors, CROs, and sites can prepare for the July 2025 implementation and navigate this transition.