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The European Medicines Agency (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) and machine learning (ML) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper is part of the joint HMA-EMA Big Data Steering Group (BDSG) initiatives and has been developed in liaison between the BDSG, EMA’s Committee for Medicinal Products for Human Use (CHMP) and its Committee for Veterinary Medicinal Products (CVMP). AI and ML tools have the potential to effectively support the acquisition, transformation, analysis, and interpretation of data across the medicinal product lifecycle.