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The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.
The European Medicines Agency (EMA) announced on Dec. 18, 2023 that it has, along with the Heads of Medicines Agencies (HMAs), published a strategy for coordinating the use of artificial intelligence (AI) in medicines regulation. The Multi-annual AI Workplan 2023–2028 was developed by the HMA-EMA Big Data Steering Group (BDSG) to coordinate a strategy to best use the benefits of AI and minimize any risks associated with its use and help the European medicines regulatory network (EMRN) to utilize AI for the automation of processes and evaluating data.
“The increasingly sophisticated nature and the pace of change of AI bring opportunities but also challenges. The application of AI requires a collaborative, coordinated strategy to maximize the benefits from AI while ensuring that uncertainty is adequately explored, and risks are mitigated,” the document states.
The workplan focuses on four key elements:
“As AI technology is fast evolving, including the ethical and policy aspects related to it, the BDSG will regularly update the workplan. Regulators, medicine developers, academics, patient organizations, and other interested parties will be informed and engaged throughout the implementation of the plan,” EMA stated in a press release.