ICH E6(R3) Demystified: What It Means for You
ICH E6(R3) is officially here, and it’s changing the game for sponsors and sites. Whether you’re running trials or supporting them, this new GCP guidance brings a fresh set of expectations around how you handle data, monitor sites, and manage systems.
This isn’t about overhauling your entire process—it’s about understanding what’s changed, what you actually need to do, and how to avoid getting caught off guard during an inspection.
Join Florence Healthcare’s Andrea Bastek and Sara Saunders for a breakdown of the new rules. We’ll cover what’s different, why it matters, and how to help your sites stay compliant (even if they’re still using paper).
Whether you’re new to ICH guidance or just need a sanity check, this session is designed to make R3 make sense.
What You’ll Learn:
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What's changed in E6(R3) and why it matters
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What sponsors are now responsible for (and what's still on your sites)
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How to get ahead of audit risk without overwhelming your team
Meet the Panelists

Andrea Bastek
VP Market Strategy
Florence Healthcare

Sara Saunders
Sr Manager, Regulatory Affairs
Florence Healthcare