Key points:

• The human touch remains irreplaceable as artificial intelligence (AI) and machine learning (ML) tools become more common. While AI technologies hold great potential to streamline operations in organisations, meticulous planning and testing are imperative for their successful integration. Embracing change and fostering innovation is key to leveraging the efficiencies that AI can offer across all company departments
• AI is only as powerful as the data you give it. It is not neutral or unbiased and it is not a one-size-fits-all tool. With the EMA’s publication of the reflection paper on the use of AI in the medicinal product lifecycle and the increasing integration of AI and ML technologies in our regulatory landscape, the question arises: are we adequately considering how these tools can transform the roles of regulatory professionals in both industry and health authorities? Collaboration between authorities is critical

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