This IQVIA whitepaper stresses the need for stronger AI governance in drug safety. Regulators like the EU, FDA, and EMA are setting strict frameworks, with the EU AI Act imposing binding rules for high-risk AI from 2026. Key challenges include trust in opaque LLMs, entrenched legacy workflows, and lack of validation standards. Solutions focus on embedding AI governance: risk-based oversight, transparency, privacy safeguards, bias mitigation, and continuous monitoring. Success requires multidisciplinary collaboration and proactive partnerships. The message: governance must evolve alongside AI to ensure safety and compliance.

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