The ICH GCP R3 Roadmap: Risks management and R3

ICH GCP is changing — and so is the meaning of “risk management.”
With ICH GCP R3, regulators are no longer interested in perfect paperwork. They are interested in clear thinking, proportional controls, and real protection of patients and data.

This webinar goes beyond theory.

What you will really learn

• The true risk-management logic of ICH R3 — what regulators mean, not just what the text says
• The most common mistakes CROs make when applying risk-based approaches (and why they keep repeating them)
• Why many “Risk Management Plans” look impressive — but fail under inspection
• How CROs, as a core execution engine of clinical trials, must manage not only trial risks, but organizational risks
• Where the line actually is between trial risk and company-level risk under ICH R3

A unique perspective you won’t get from guidance documents. This session includes a real-world perspective from a Ukrainian CRO that has conducted trials through war-time disruptions, infrastructure instability and a sudden operational shocks.

Not as a dramatic story — but as a practical lesson in what real business continuity looks like when patient safety and data integrity must not stop.