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In Good Pharmacovigilance Practices (GVP) Module VI, adverse event reporting is a crucial aspect of ensuring the safety of medicinal products. Here’s an overview of adverse event reporting based on GVP Module VI: 1. Definition of Adverse Event (AE) and Serious Adverse Event (SAE): GVP Module VI typically provides definitions for adverse events and serious […]
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ICH E2B(R3) is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline is focused on the standardization of the format, content, and structure of individual case safety reports (ICSRs) for the electronic transmission of safety information for medicinal products, particularly for adverse events (AEs) […]
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