Thank you, Dr. Arnold-this is a very timely and valuable resource.
The ICH E6(R3) Good Clinical Practice training guide is important to risk-based, quality-driven practices across the clinical lifecycle. From a bioanalytical perspective, it aligns with the growing emphasis on assay lifecycle management, data integrity, and proactive risk mitigation.
Appreciate you sharing-this guidance will be key in shaping how we operationalize quality moving forward.
Best regards,
Susana
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Susana Catacora-Lopez
Immunoassays Manager
Integrated Biotherapeutics
Rockville MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 01-24-2025 08:19
From: Mark Arnold
Subject: ICH E3(R6) Training Guide
ICH has released a 50 page Training guide for E6(R3) Good Clinical Practice. It is available at the link below in the WG Presentations and Training box on the right side:
https://www.ich.org/page/efficacy-guidelines#6-2
#ICH #GCP #E3(R6)
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]
Bioanalytical Solution Integration
LinkedIn: https://www.linkedin.com/in/markearnoldphd/
Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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