Understand how E6(R3) formally acknowledges a wide variety of data sources — from wearables and eCOA to routine healthcare records. What does this shift mean for data quality and oversight?
Risk-based thinking in action
Learn how proportionality is embedded throughout E6(R3) — enabling smarter planning, monitoring, and data collection. Discover how to focus on what’s critical to quality and reduce unnecessary burden.
Intentional data governance
E6(R3) emphasizes full lifecycle data stewardship — from capture to review, transfer, retention, and destruction. We’ll explore how planned audit trails strengthen transparency and trust.
Who Should Attend
Transitioning from ICH E6(R2) to E6(R3)
Involved in clinical trial design, execution, oversight, or data strategy
Seeking actionable guidance on aligning their practices with modern expectations
Speaker
I think if you do something and it turns out pretty good, then you should go do something else wonderful, not dwell on it for too long.
Wicked Problem Wizard in RBQM & Data Strategy • Over 8 years leading RBQM implementation at a global pharmaceutical company • Deep expertise in data science, analytics, and clinical trials • Industry experience across high-tech, finance, and healthcare • Holds two Master’s degrees: • M.S. in Mathematics, Courant Institute (NYU) • M.S. in Statistics, Columbia University
This session is ideal for those working in clinical operations, data management, QA, or regulatory strategy. Walk away with practical insights to help align your practices with the modern principles of E6(R3).