This discussion paper on Artificial Intelligence (AI) and GxP compliance is intended to explore the meaning of the responsibilities outlined by European Medicines Agency (EMA) for clinical trial sponsors planning to deploy AI technology in the medicinal product lifecycle, as well as to promote ideation around validation/qualification of AI-based tools in a GxP context.

The paper has been written based on a review of the EMA reflections on the use of AI in the medicinal product lifecycle and the discussion has been constructed around and linked to the clinical trial sponsor responsibilities as outlined by EMA.

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