This article delves into the critical transition occurring in post-market drug safety and global pharmacovigilance. It details how the industry is moving beyond the foundation of Individual Case Safety Reports (ICSRs) to fully incorporate the power of Real-World Data (RWD). The piece explores the need for integrating diverse data streams—such as from electronic health records (EHRs), claims databases, patient registries, and social media—to build a more holistic and current understanding of a product's safety profile in a real-world setting. Key topics include the technological and regulatory challenges of data standardization, processing massive volumes of information, and the strategies for leveraging these new insights to enhance proactive signal detection, strengthen risk management plans, and ensure continuous regulatory compliance across international markets.
