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EU Clinical Trials Regulation 11/06/2014

Posted by Shirley Hallam in Approvals, Regulatory.
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Slide21The European Union Clinical Trials Regulation 536/2014 was published in the official EU Journal on 27th May 2014.  It will enter into force on 16th June 2014, and will be implemented either from 28th May 2016, or six months after the necessary portal and databases become fully functional, whichever is the later.

The latest version of the GCP Update course offered by Hallam Pharma Consulting is now available, and includes a detailed overview of the Regulation.  Central to the new Regulation is an effort to simplify the submission and notification.  The illustration from the course materials illustrates the submission and approval timelines for part 1 of the application process.

For further details of this and other training courses please contact Shirley Hallam.

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