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The New Clinical Trial Regulation: Overview and Impact

7 October 2019 09:00 - 8 October 2019 17:00, London, United Kingdom


Introduction
Why you should attend

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). The new regulation was originally due to come into effect in 2016, however implementation has been delayed until the new portal and clinical trial database have been completed and audited. Key aims of the new regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines for enacting the new regulation are also being prepared in a number of areas including inspection, investigational medicinal product and trial documentation etc.

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for biopharmaceutical companies, CROs and study sites.
Speakers
  • Dr Laura Brown United Kingdom

Venue
Rembrandt Hotel

Rembrandt Hotel, 11 Thurloe Place, London, SW7 2RS, United Kingdom

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