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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 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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Understanding the CTD: Where Clinical Data Meets Regulatory Writing By ‘Femi Fajimi | 29 May 2025 The Common Technical Document (CTD) is the backbone of global regulatory submissions. A standardised format that allows pharmaceutical companies to present evidence to regulatory authorities across regions. For medical writers, especially those working in clinical and regulatory settings, understanding…
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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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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…
'Femi Fajimi 