EMA Offers ‘Dynamic Demo’ Of New Clinical Trials Portal
Executive Summary
The European Medicines Agency will hold a webinar to explain and demonstrate specific functionalities of the new clinical trials system relevant to clinical trial sponsors.
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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 Fine-Tunes Guidance For New Clinical Trials System
With a clear implementation date now in sight for the EU Clinical Trials Regulation, the European Commission is focusing its efforts on finalizing additional guidance and templates to support compliance. The pharmaceutical industry wants access to a test version of the new CT portal so that companies can make the necessary adjustments to their own systems.
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.