The new EU Clinical Trial Regulation (536/2014) will replace 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 database and /> Guidelines for enacting the new Regulation have also been prepared in a number of areas
including inspection, investigational medicinal products and trial /> 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 programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, vendors and study sites.