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Mastering the ICSR: Case Processing in Pharmacovigilance https://WebToolTip.com Published 10/2026 MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch Language: English | Duration: 3h 24m | Size: 913.41 MB Validity, Day Zero, MedDRA coding, seriousness, causality and narratives: process ICSRs that hold up at inspection What you'll learn Apply the four minimum validity criteria, manage pending-invalid cases and detect duplicates across sources Set Day Zero correctly and calculate every reporting deadline for US, EU, Canadian and clinical trial destinations Code adverse events in MedDRA following the Points to Consider for diagnoses, symptoms, lab values and deaths Assess seriousness against the six ICH E2A criteria and keep severity and seriousness as separate judgments Assess causality with WHO-UMC and Naranjo and decide when a trial case is a SUSAR Write clear, inspection-ready case narratives, including pregnancy, death and medication-error cases Explain how case handling differs between clinical development and postmarket settings, including blinding Use compliance metrics, reconciliation, root cause analysis and CAPA to keep a case-processing operation audit-ready Requirements Basic clinical literacy: comfort with common medical terms, lab values and how medicines are prescribed A general idea of how drugs are developed and approved; no prior pharmacovigilance experience is required A web browser if you want to follow the optional demonstrations in the free ICSR Workbench