The End of GCP As We Know It? ICH E6(R3) Readiness Training by Former FDA Director
The ICH E6(R3) guideline is a regulatory turning point. If your oversight models, delegation logs, or system validation strategies are stuck in pre-COVID mode, your next FDA inspection could expose major risks.
In this on-demand webinar, join guest speaker, Jonathan Helfgott, MS — former FDA Bioresearch Monitoring (BIMO) reviewer— for a no-fluff, inspection-focused session that breaks down what R3 really means for sponsors, sites, and vendors in 2025 and beyond.
You’ll Learn:
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- Why “principles-based flexibility” won’t protect you when your systems fail inspection
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- How to align with both R3 and 21 CFR Parts 11, 50, 56, 312, and 314
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- What FDA now expects from decentralized tech platforms and vendors
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- How to validate systems for fitness-for-purpose, not just passively “install” them
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- Why audit trails and traceability are now your #1 defense
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- How to document oversight and structure delegation logs for audit-readiness
You’ll Also Receive:
✅ R3 Risk Readiness Matrix: A pre-scored tool to assess your compliance posture across R3 principles — mapped to CFR expectations.
✅ Slide Deck + Narration Script + Full Webinar Video: Jonathan’s full breakdown — for internal team training or SOP development.
✅ 15-Minute Live Q&A with Jonathan Helfgott: Ask direct questions about your program, your risks, and what the FDA actually looks for.
Who This Is For:
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- Clinical Operations & Regulatory Affairs teams
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- QA & Audit professionals
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- Tech vendors building eConsent, ePRO, wearables, or remote monitoring tools
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- Investigators and Sites preparing for R3 implementation
