AI Complexity Not A ‘Free Pass’ To Dodge Regulatory Standards, EMA Warns
Companies that use AI technologies will be responsible for demonstrating that regulatory standards are met and that the data they provide “has not been synthetically generated or completely made up,” an EU workshop heard this week.
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Consistency and coherence with other relevant regulations should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence in the drug lifecycle, pharmaceutical industry representatives have said.
A two-day workshop saw EU policymakers and regulators meet with dozens of representatives from the pharmaceutical, health and medtech industries to discuss the future of regulating AI in medicine and its uses in the medicinal product lifecycle.
The artificial intelligence revolution has arrived, but are pharmaceutical companies ready to meet the expectations of regulators? Lawyer Vincenzo Salvatore outlines the EU regulatory and policy developments that are relevant to the use of AI in the medicinal product lifecycle.