ICH E8 R1 encourages us to create “a culture that values and rewards critical thinking and open, proactive dialogue…” Some are surprised that we need regulators to tell us to think critically. In this interactive session, after providing background, we will explore questions such as: What happens if critical thinking isn’t used during RBQM? How can we encourage people to think critically as they define, prioritize, control, and manage risks? Does thinking critically mean we should throw out all those checklists? Do we need humans to work in an RBQM environment, or can’t the machines/systems manage the risks for us?