Demanding More from AI Governance in Drug Safety

Artificial Intelligence (AI) usage continues to expand in the pharmaceutical space, with many drug companies considering how to implement this technology to increase efficiency and enhance decision-making across the lifecycle of a drug, while Marketing Authorization Holders must also ensure compliance amid an evolving regulatory landscape. Regulators have encouraged the use of AI in drug development and manufacturing, but their guidance remains largely in draft form and is subject to change as new insights come to light. This white paper reviews and explains the current regulatory climate, challenges, and solutions for moving from traditional to generative AI in drug safety.