FemiFajimi
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Writing Lay Summaries: What I Didn’t Expect to Learn as a Regulatory Writer By Femi Fajimi | 27 November 2025 (Educational content. No confidential information included.) Introduction When I started learning regulatory medical writing, I assumed that lay summaries were “scientific findings rewritten in simpler language.” I expected the usual tasks: reducing jargon, shortening sentences,
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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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Understanding Pre-Clinical Modules of the CTD – A Dermalexiin Case Study By Femi Fajimi | 02 July 2025 Introduction: The CTD and Its Pre-Clinical Modules Regulatory medical writers often encounter the Common Technical Document (CTD) format when preparing submissions for new medicines. The CTD is organised into five modules, where Module 4 compiles all pre-clinical (nonclinical)
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Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol
Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol By Femi Fajimi | 02 June 2025 Introduction When I first heard the term Paediatric Investigation Plan (PIP), I assumed it was just a clinical trial protocol for children. But I soon realised it’s a much broader regulatory tool, one that
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From Numbers to Narrative: Learning to Understand Clinical Data as a Medical Writer By ‘Femi Fajimi | 22 May 2025 One of the most valuable skills I’m developing as a regulatory medical writer is the ability to interpret clinical data clearly and accurately. I’m learning that writing about trial outcomes isn’t just about listing results
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Understanding Protocol Amendments: A Beginner’s Perspective By ‘Femi Fajimi | 14 May 2025 As I continue developing my skills in regulatory medical writing, I’m learning that clinical trial protocols don’t always remain fixed. In practice, they often need to be revised, and that’s where protocol amendments come in. Understanding amendments has helped me see how
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Basic Results and Trial Disclosure Reporting: Transparency in Action By ‘Femi Fajimi | 30 April 2025 As I continue developing as a regulatory medical writer, one key area that stands out is the importance of trial transparency. Clinical research does not end when a study closes; it extends to how results are reported and shared
'Femi Fajimi 