Brexit Likely To Force ‘Refocusing’ Of Ambitious EU Network Strategy
The European Medicines Agency and drug regulators throughout the EU are having to invest huge amounts of time and effort in dealing with the fall-out from Brexit - and it hasn't even happened yet. Plans for working together on bigger issues agreed on a few years ago will likely have to change, senior regulator Thomas Senderovitz tells the Pink Sheet.
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Changing mindsets, technologies outpacing regulatory frameworks, intense international collaboration, and the future of the randomized controlled clinical trial. Big data is forcing us to think big, senior European regulator Thomas Senderovitz tells the Pink Sheet.
The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.
Europe’s medicines agency heads say they are pressing on as planned with the priorities and activities in the joint “strategy to 2020” they have with the European Medicines Agency. But this could change and, in any case, more resources are needed and agencies need to engage more to support delivery of their plan.