Article summary
The Innovative Medicines Initiative (IMI) has recently attended the regulatory science summit with the European Medicines Agency and the US Food and Drug Administration. The aim of the summit was ‘to identify scientific gaps that could be addressed collaboratively within a public-private partnership such as IMI, and to ensure that potential IMI projects would deliver tangible results that are relevant from a regulatory perspective to maximise their impact on drug development and on the delivery of innovative products to patients’. Attendees at the summit stated that ‘unblocking the regulatory challenges surrounding advanced therapies and digital technologies could be game-changing for all players’.
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