ICH E3
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From “Raw TFLs” to Regulator-Ready Narratives: A Medical Writer’s Walkthrough (Antifungal Case Study) By Femi Fajimi | 10 September 2025 (Educational content. Drug, data, and outputs below are fictional but formatted to mirror real deliverables.) Introduction Sometimes, when I am asked to support some freelance writers with their ongoing projects, particularly when it involves reviewing
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Writing Clinical Overviews and Clinical Summaries in Regulatory Submissions: A Regulatory Writing Walkthrough with Oncometherin By Femi Fajimi | 26 July 2025 (Educational content. Oncometherin is a fictional investigational product.) Introduction: Clinical Modules at the Heart of Regulatory Submissions Regulatory medical writers play a pivotal role in preparing the documentation that supports new medicine applications.
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Clinical Trial Protocols and Clinical Study Reports (CSRs): A Beginner’s Perspective By Femi Fajimi | 28 April 2025 As I continue developing my skills in regulatory medical writing, I am learning how essential two key documents are to the clinical trial lifecycle: the protocol and the clinical study report (CSR). Protocols define a study’s blueprint,
'Femi Fajimi 