Training For ‘Huge’ EU Clinical Trials Portal And Database On Track For 2017
“Thousands and thousands of people” will be using the EU clinical trials portal and database after it goes live late next year and the European Medicines Agency plans to “invest a lot” this year in teaching trial sponsors and EU member state authorities how to use the new system. The EMA is also still working on ironing out the tricky areas of user management and how to transition legacy trials.
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The go-live date for the coming EU Clinical Trial Regulation and accompanying portal and database is being postponed again. The delay will also impact the EMA’s schedule for training drug sponsors and European authorities in how to use the portal and database.
Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.
The European Commission has issued revised delegated legislation explaining new GMP requirements and inspection arrangements for investigational medicinal products that will come into play when the EU Clinical Trials Regulation kicks in.