IQVIA艾昆纬：2024年提高患者安全性：药物警戒工作流程中早期采用人工智能的范式转变报告（英文版）

In the high-stakes, ever-evolving landscape of pharmacovigilance (PV), the imperative to ensure patient safety is spurring innovative approaches. Traditional PV operations typically start at ‘Case Processing,’ but the persistent challenge of underreported adverse drug reactions (ADRs) demands a paradigm shift. The FDA’s estimate that only 1–10% of ADRs reach the Adverse Event Reporting System (FAERS) underscores a need for a more proactive strategy. This paper stems from the US FDA Discussion pa