European Medicines Agency Restructures To Tackle New Challenges
Multiple Pressures Prompt ‘Future Proofing’ Exercise
A restructuring involving the setting up of four new task forces is aimed at improving how the European Medicines Agency responds to issues such as permanent staff reductions and challenges in regulatory science, digital business transformation, and clinical trial strategy.
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Europe’s top drugs regulator has reorganized its operations to tackle what it calls “fundamental changes” brought by new legislative initiatives, digital technologies, global trends in science, and staff losses due to Brexit. More changes are to be implemented during the course of 2020 in a bid to optimize the agency’s regulatory and scientific output.
As the EMA settles into its permanent headquarters in Amsterdam, it hopes that new recruits will swell its depleted staff numbers. But much will depend on the necessary expertise being available, particularly following the loss of access to experts working at the UK regulator, the MHRA.
The head of the European Medicines Agency is nearing the end of his tenure. We consider Guido Rasi’s achievements over the past 10 years as well as the controversies that have arisen under his leadership – and report that sailing is likely to figure in his plans for life after the agency.