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Rising Importance of Real-World Evidence in Pharmacovigilance

The Pharmacovigilance Market growth is increasingly shaped by the adoption of real-world evidence (RWE). Traditional safety monitoring focused on clinical trial data, but real-world insights from healthcare databases, patient registries, and electronic medical records are now essential to understanding drug risks.

Regulators encourage the integration of RWE to improve post-market surveillance, detect rare adverse events, and assess long-term safety profiles. For instance, cancer therapies, biologics, and cell and gene therapies require ongoing monitoring beyond trial settings, which real-world data makes possible.

This shift not only strengthens patient safety but also supports adaptive regulatory decision-making. With the global healthcare industry digitizing rapidly, RWE-driven pharmacovigilance is expected to be one of the fastest-growing segments in the industry.

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