Pharmacoepidemiology and Real-World Evidence

This session focuses on the application of pharmacoepidemiology and real-world evidence (RWE) to understand drug utilization, effectiveness, safety, and outcomes in diverse populations, bridging the gap between clinical trials and routine clinical practice. The session will explore how biological, demographic, and clinical factors influence drug response and adverse events in large populations, providing insights beyond controlled experimental settings. Topics include study designs such as cohort, case–control, and cross-sectional studies, as well as observational databases, electronic health records, and registries used to generate RWE. The session will emphasize the role of pharmacovigilance, risk assessment, and post-marketing surveillance in identifying rare adverse events, long-term safety issues, and drug–drug interactions, highlighting how these insights inform clinical guidelines and regulatory decisions. Participants will learn how integrating pharmacokinetic, pharmacodynamic, genetic, and biomarker data with population-level analyses can improve understanding of variability in drug response, optimize treatment strategies, and enhance patient safety. Real-world examples will demonstrate how RWE informs policy, formulary decisions, comparative effectiveness research, and personalized therapy. The session will also address challenges in data quality, confounding factors, bias, and ethical considerations in observational research. Emerging approaches, including advanced analytics, machine learning, and predictive modeling, will be highlighted for their potential to improve study accuracy and clinical relevance. By linking biological knowledge with population-based evidence, this session aims to equip participants with the tools and understanding necessary to interpret and apply real-world data effectively, ultimately improving therapeutic decision-making, regulatory oversight, and patient outcomes.

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