#ICHE6 hashtag - Bluesky

@yassereldershaby.bsky.social

8 months ago

ICH E6 (R2) Explained | GCP Guidelines for Clinical Research, Investigators & Medical Affairs Discover the Essentials of ICH E6 (R2) – The Global Standard for Good Clinical Practice (GCP) Whether you're an investigator, Medical Affairs leader, clinical operations professional, or part of a research team—understanding ICH E6 (R2) is no longer optional. It’s the backbone of ethical, high-quality clinical trials. 🎯 In this tutorial, you’ll learn: What is ICH and why it was created The scope and purpose of the ICH E6 (R2) guideline A breakdown of the 13 core principles of GCP The structure of the E6 guideline and how to use it in your daily work Why understanding E6 matters for inspections, compliance, and patient safety 💡 Learn how this international guideline ensures trial credibility, protects participant rights, and aligns all stakeholders—from sponsors and investigators to ethics committees and monitors. 📌 Whether you're reviewing protocols, overseeing data, or engaging with trial sites—this tutorial will give you the foundation to lead with...

ICH E6 (R2) Explained | GCP Guidelines for Clinical Research, Investigators & Medical Affairs
youtu.be/WVJRbC7XQGQ

#ICHE6 #GCPGuidelines #ClinicalResearch #GoodClinicalPractice #MedicalAffairs #ICHE6R2 #ClinicalTrials #ClinicalOperations #ResearchCompliance #InvestigatorTraining

Yasser ElDershaby, MD. MSc. NC.

@yassereldershaby.bsky.social

8 months ago

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...

🚨 ICH E6 (R3) goes live July 25, 2025!

A major update from R2 (2016), with big implications for #MedicalAffairs & #ClinicalResearch teams.

🎥 R3 Tutorial (Watch July 25): youtu.be/WenjnCSXzcM
📺 R2 Recap (Watch July 23): youtu.be/WVJRbC7XQGQ

#ICHGCP #ICHE6 #GCP #SkyHealthAcademy #Investigators