Femi Fajimi
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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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The Investigational Medicinal Product Dossier (IMPD): An Overview from a Developing Medical Writer By Femi Fajimi | 23 June 2025 Regulatory medical writing requires a blend of scientific insight, structured communication, and regulatory awareness. As a developing writer, I’ve come to realise that the work extends beyond writing well; it’s about presenting data, safety, and…
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Writing Safety Updates in Regulatory Medical Writing: An Overview of RMPs, DSURs, PADERs, and PBRERs from a Developing Writer’s Perspective By ‘Femi Fajimi | 13 July 2025 One of the most critical responsibilities in regulatory writing is preparing safety documents that monitor, assess, and communicate drug safety throughout its lifecycle. These documents help regulatory authorities…
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Understanding the ICH Guidelines: E3, E6, and E8 from a Medical Writer’s Perspective By ‘Femi Fajimi | 05 May 2025 Becoming confident in regulatory medical writing involves more than understanding clinical content; it also means becoming familiar with the guidelines that shape how studies are conducted and reported. The International Council for Harmonisation (ICH) issues…
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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,…
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Starting Somewhere By Femi Fajimi | 21 April 2025 Every journey begins somewhere, and for me, this is it.Welcome to my blog. I’m a healthcare professional with a medical, public health, and oral health education background. Over the years, I’ve worked in both clinical and community-based roles, but what has remained consistent is my interest…
