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Beyond the Buzzwords: Oversight, Quality by Design, and Risk-Based Thinking

This fast-paced, highly interactive lecture helps clinical research and quality professionals move beyond terminology and into real-life application. Participants will examine practical strategies and thinking to implement oversight, Quality by Design (QbD), and risk-based thinking in day-to-day trial decisions. Drawing on ICH E6(R3) expectations and real-world examples from both site and sponsor perspectives, the session includes guided activities and tools that help translate regulatory concepts into operational action. Attendees will also gain bonus takeaways that demystify two additional ICH E6(R3) expectations—data governance and fit-for-purpose thinking—showing how these newer terms apply to documentation, system design and oversight, and proportional quality approaches. Interactive elements such as Buzzword Bingo and a closing Jeopardy-style quiz reinforce key concepts and encourage critical thinking. This session is ideal for site and sponsor professionals seeking clarity, confidence, and practical insight into applying ICH E6(R3) in the real world.

CEU: 1.00 ACRP

Speaker:

Earlier Event: April 26
Bridging the Gaps to Succeed as a Multigenerational Team
Later Event: April 27
Applying Artificial Intelligence to Site Selection and Feasibility