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 portal.
Guidelines for enacting the new Regulation have also been prepared in a number of areas
including inspection, investigational medicinal products and trial documentation.
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.
Who Should Attend?
This course is ideal for anyone requiring an update on the EU Clinical Trial Regulation
The course is relevant for those working in:
• Clinical research
• Clinical operations
• Project management
• Quality assurance (GCP auditors)
• Vendor/CRO professionals
• Study sites
And other professionals in pharmaceutical and biotechnology organisations conducting
trials with drugs, biologics or combination products.
It will also be of interest to those departments who liaise with/support clinical trial personnel, and all other professionals who want to know more about this important new regulation.