Pharmacovigilance writing
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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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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