Regulatory Affairs
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An educational narrative review from a medical writing perspective By Femi Fajimi | 18 May 2026 Abstract Clinical trial lay summaries have emerged as important tools for improving transparency and public understanding of clinical research following increasing regulatory emphasis on patient-focused communication. Regulatory frameworks such as the European Union Clinical Trials Regulation (EU CTR) No.…
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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…
'Femi Fajimi 