MHRA Inspection Insights: ICH E6(R3) and the Next Chapter of Quality

As regulators adopt the principles of ICH E6(R3), the MHRA is taking a closer look at how organizations apply risk proportionate oversight, quality by design, and documentation that proves control. In this live session, Stacy Collins and Laurel-Ann Schrader explore what these expectations mean in practice through a recent MHRA inspection case study.

You will see how one sponsor translated E6(R3) into actionable processes, mapping SOPs to evidence, documenting risk-based decisions, and using targeted metrics to show inspection readiness. The session will walk through inspection findings, root-cause analysis, and the specific improvements that led to measurable quality gains.

You will learn how to:

Apply E6 (R3) principles to real-world MHRA inspection scenarios

Strengthen TMF completeness and quality through risk-proportionate decisions

Build governance models that prove oversight without adding noise

Use metrics and documentation to show control and continuous improvement