Talk Risk-Based Quality Management track
The RBQM Trap: Can You Prove Your Risk Assessment Changed Study Conduct?
Tue, Oct 13, 2026 · 10:30–10:43 AM CEST InterContinental Barcelona
About this session
Sponsored by Cyntegrity Germany GmbH. Most clinical teams can produce a risk assessment, but far fewer can prove it changed study conduct. Under ICH E6(R3), documented risks that are not translated into action are increasingly difficult to defend. This talk contrasts administrative and operational RBQM, showing how connected evidence transforms risks into concrete actions, measurable outcomes, and inspection-ready proof. Key takeaway: Stop scoring risks and start proving you changed the study.
Speaker
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CEO & Founder · Cyntegrity Germany GmbH
Speaker
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