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ICH E6(R3): If E6(R2) Was Already Effective, Why Do We Need R3?-A Medical Writer’s Perspective By Femi Fajimi | 13 May 2026 (Educational content. No confidential information included.) Introduction International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (GCP) guidelines have long served as the ethical and scientific foundation…
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Lay Summaries in Clinical Trials: A Beginner’s Perspective on Making Research Understandable By ‘Femi Fajimi | 29/ April/2025 As a beginner regulatory medical writer, I am learning that writing clinical trial documents involves more than technical precision. Increasingly, regulatory requirements demand that clinical research results be communicated to the public in a clear, factual, and…