Operationalizing ICH E6(R3): Redefining Monitoring, Mindset, and Trial Design
Wed, Sep 16
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11:05 AM - 11:40 AM
Session details:
The release of ICH E6(R3) has sparked renewed debate across the industry: are we prepared to operationalize modern quality principles, or are legacy habits still driving decision‑making? This panel will explore the cultural, regulatory, and operational barriers slowing adoption—and what true modernization requires. Panelists will discuss:
- Why legacy assumptions—such as reliance on 100% SDV—continue to persist despite long‑standing risk‑based guidance
- How defining what is critical to quality at the trial design stage can shape monitoring strategies and operational priorities
- The impact of global regulatory inconsistency on E6(R3) adoption and sponsor decision‑making
- How moving from a checklist‑driven compliance focus to critical, risk‑focused thinking will shape the skillsets of the future CRA role
- How E6(R3) challenges sponsors to rethink operational practices to meaningfully reduce site and participant burden
