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EMA Has Work Cut Out Before New Clinical Trial Portal Goes Live

Executive Summary

Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.

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New EU Clinical Trial System Has Implications For Wider Study Operations

Companies readying themselves for the upcoming implementation of the EU Clinical Trial Regulation should think beyond its obvious stated aim of harmonizing the submission and evaluation of trial applications. The regulation, which will be implemented via a new portal, has the potential to affect several business dimensions.

EMA Explains Dos And Don’ts Of New Clinical Trials Portal

Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.

EU Clinical Trials Regulation To Apply From December 2021

Executive Summary: The European Medicines Agency’s management board has decided on December 2021 as the go-live date for the EU Clinical Trials Information System. It will also meet later this month to elect the EMA’s new executive director to succeed Guido Rasi. 

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