Скачать или смотреть Pharmacovigilance Interview: Mastering ICSR to signal detection | Aggregate Reporting

This video serves as a comprehensive guide to Pharmacovigilance (PV), which is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
We cover the transition from foundational knowledge, like the difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR), to advanced concepts required for a strategic analyst role.
Key Concepts Reviewed:
• Aggregate Reports: We explain the purpose of reports like the Periodic Benefit-Risk Evaluation Report (PBRER), which is the updated standard for marketed products, emphasizing the structured benefit-risk evaluation. This differs from the Development Safety Update Report (DSUR), which focuses on investigational drugs during clinical development.
• Data Integrity: We discuss the importance of the Individual Case Safety Report (ICSR) as the fundamental building block of PV, and how all reported data must be included up to the Data Lock Point (DLP).
• Signal Management: Learn the systematic steps of the signal management process: Detection, Validation, Evaluation, Recommendation for Action, and Tracking. A signal is new information about a potential causal association, which may eventually become an identified risk.
• Coding & Reporting: Essential tools include MedDRA (Medical Dictionary for Regulatory Activities) for standardized terminology and the use of Standardised MedDRA Queries (SMQs), which can be run as either Narrow (high precision) or Broad (high sensitivity) searches. We also review the four minimum criteria for a valid ICSR and the requirements for expedited reporting of serious, unexpected ADRs (SUSARs) within 15 calendar days

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