EU Clinical Trial Regulation 536/2014: Overview and Implementation
The new EU Clinical Trial Regulation (536/2014) replaces the European Clinical Trials Directive (2001/20/EC) in 2022. 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 CTIS (Clinical Trial Information System).
This course will provide an essential understanding to help with compliance with the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU.
The programme will highlight the most important of these key requirements and how these are likely to impact on trials for biopharmaceutical companies, vendors and study sites.