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Yasser ElDershaby, MD. MSc. NC.
Yasser ElDershaby, MD. MSc. NC.
@yassereldershaby.bsky.social
8 months ago
New ICH E6 R3 Guideline Explained | Effective July 25, 2025
New ICH E6 R3 Guideline Explained | Effective July 25, 2025 📢 The new ICH E6 R3 is finally here — effective July 25, 2025. If you work in clinical research, trials, regulatory affairs, or medical affairs, this is a must-watch. In this tutorial, we break down the latest updates in ICH E6 R3—what’s changed, why it matters, and how to adapt your clinical and operational processes to align with the new expectations. ✅ In the related tutorial, we also covered ICH E6 R2 in detail. Now, in this new release, you’ll discover: What’s new in the ICH E6 R3 compared to R2 The key principles and structural changes How the new guideline enhances participant protection, data integrity, and digital readiness Real-world examples of how R3 impacts Sponsors, CROs, Investigators, and Ethics Committees Actionable tips to ensure your teams and SOPs stay compliant Whether you're a CRA, clinical trial manager, MSL, GCP trainer, or regulatory specialist — this video will bring...

New ICH E6 R3 Guideline Explained | Effective July 25, 2025
youtu.be/WenjnCSXzcM

#ICHGCP #ICHE6R3 #NewICHE6R3 #ClinicalResearch #GCPTraining #ICHGuidelines #ClinicalTrials

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RegDev
RegDev
@regdevinc.bsky.social
11 months ago
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The updated R3 guidelines offer a substantial revision -- some of the key changes featured:

✅ Modernized Structure
✅ Innovation in Clinical Trials
✅ Fit For Purpose Focus on Risk
✅ Transparency
✅ Data Governance

#RegDev #GCP #ICHE6R3 #DrugDevelopment #Pharma #Biotech #Regulatory #Compliance

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