EMA to drug developers on AI: Carry out thorough risk assessments
The EMA is urging drug developers to appropriately assess the risk of using artificial intelligence or machine learning in the drug development process and to seek regulatory interactions early on, in a new reflection paper addressing the growing use of AI/ML in drug development.
In a 17-page paper published July 10, EMA lays out the role of AI and ML throughout the lifecycle of medicinal products. Further regulatory guidance on risk management in drug development will be forthcoming, the agency says.
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