📢 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. 🎓 This Tutorial is part of our ICH-GCP Certification Program for ICH-GCP Certification Program: Comprehensive Training for Investigators, CRAs, CROs, and Medical Affairs Professionals | 8 Weeks, 100% FREE, Check it Now: https://www.skyhealthacademy.net/challenge-page/ich-gcp-certification-program?programId=87353fc7-9eb7-4ce5-9bf5-1fca3dede0cd ✅ In the 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,...

In this essential tutorial, you’ll explore the ethical principles and subject protection guidelines that form the foundation of Good Clinical Practice (GCP). From the protection of human subjects to the details of the informed consent process, we break down what every investigator, Medical Affairs professional, and clinical research team must know. 👉 You’ll learn: The importance of ethical safeguards in human research How informed consent is more than just a form—it’s a process What responsibilities investigators and sponsors have to protect subjects How global frameworks like the Declaration of Helsinki shape modern GCP Whether you're preparing for a GCP certification, designing a study, or engaging with investigators, this video will help you strengthen your understanding of subject protection and your role in upholding ethical standards. 🛡️ Protecting participants isn’t just about compliance—it’s about trust. 📌 Watch now and reinforce your foundation in GCP. #EthicalPrinciples #SubjectProtection #ClinicalResearch #InformedConsent #GoodClinicalPractice #ICHGCP #MedicalAffairs...

Understand Safety Reporting and Pharmacovigilance in Clinical Trials—from AEs, SAEs, and SUSARs to DSMBs, timelines, and reporting responsibilities. Essential for Medical Affairs and investigators. In this tutorial, you’ll learn: ✅ What qualifies as an Adverse Event (AE) vs Serious Adverse Event (SAE) ✅ How and when to report SUSARs ✅ The different safety reporting roles for Investigators and Sponsors ✅ Safety Reporting Timelines and Regulatory Expectations ✅ The role of Data Safety Monitoring Boards (DSMBs) ✅ Real-world implications of failing to report properly Whether you’re in Medical Affairs, Clinical Operations, or serving as an Investigator—this tutorial offers a clear, concise breakdown of what’s required to stay compliant and protect patients. 📌 Watch now and enhance your clinical trial safety skills. 👉 Subscribe for more free tutorials 👉 ICH- GCP Certification 👉 https://shorturl.at/5ULTO 👉 Visit our website for more resources: https://www.skyhealthacademy.net #SafetyReporting #Pharmacovigilance #ClinicalTrials #MedicalAffairs #SAE #AE #SUSAR #DSMB #ClinicalResearchTraining #SkyHealthAcademy...