Most organizations have an RBQM framework. Far fewer can prove that it’s working.

As ICH E6(R3) raises expectations around Quality by Design, proportionality, sponsor oversight, and continuous risk management, having the right processes on paper is no longer enough. Organizations must be able to show how critical risks were identified, why certain signals triggered action while others did not, who owned the decision, and whether the system ultimately protected participants and critical trial data.

The 7th Risk-Based Quality Management Summit happening January 12–13 in Philadelphia is built for that next stage of RBQM maturity. We’ll move beyond familiar frameworks into the decisions that determine whether RBQM succeeds in practice. Through real-world case studies, peer benchmarking, inspection simulations, investigation exercises, and collaborative workshops, experienced leaders will pressure-test how they:

• Identify what is truly critical to quality
• Build KRIs that drive decisions instead of dashboard noise
• Interpret complex and conflicting risk signals
• Establish clear decision rights across sponsors, CROs, sites, quality, clinical, data, and statistics
• Apply AI without losing context, transparency, or human judgment
• Defend proportional, judgment-based decisions during inspection
• Demonstrate credible evidence that RBQM is improving quality and oversight

This isn’t another conversation about what RBQM should look like, but where the industry works through what happens when RBQM meets reality.