Sponsors Responsible For Ensuring AI Is ‘Fit For Purpose,’ Says EU Regulator

Regulators do not have the resources to “double check” that companies are using AI appropriately, meaning that manufacturers must ensure the AI tools they use meet relevant standards, says an EU regulatory expert.

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Pharma companies that use AI at any stage in the drug lifecycle must ensure that their algorithms, models and datasets are fit for purpose and explainable, according to Gabriel Westman, head of AI at the Swedish Medical Products Agency (MPA).

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