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ICH E6(R3) is Final—Are You Still Running an R2 Program? A Reality Check for Sponsors and CROs

The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice didn't just update language from version R2, it fundamentally shifted what regulators expect as evidence of quality oversight. Yet most midsized sponsors and contract research organizations (CROs) are still operating on R2 assumptions: reactive monitoring, fragmented trial master file oversight, and Corrective and Preventive Action plan systems that document problems without preventing them.

This session delivers an honest diagnosis of the most common R3 compliance gaps in lean organizations, a practical framework for closing them before the next inspection, and a scalable quality oversight model that doesn't require an enterprise quality assurance team to sustain.

CEU: 1.0 ACRP

Speaker:

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