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Suspected Unexpected Serious Adverse Reactions (SUSARs) represent one of the highest regulatory risk areas in clinical development. Health Authorities (HAs) globally, including the FDA, EMA, and national competent authorities, impose strict timelines and documentation expectations for SUSAR identification, assessment, and reporting. Sponsors frequently delegate pharmacovigilance (PV) case processing and regulatory reporting activities to Contract Research […]
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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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