The impact of EU 536/2014
Currently, conducting clinical trials within the European Union (EU) can be problematic, making the continent a less favorable location in comparison to other regions. To combat such issue, the EU has introduced a new regulation which replaces the European Clinical Trials Directive (2001/20/EC). The aim of EU 536/2014 is to create a more favorable environment for clinical trials, and to harmonise the requirements for performing clinical trials within the EU member states.
EU 536/2014 | Notable changes:
Identical throughout the EU
With the status of EU 536/2014 being a regulation, it differs from the current European Clinical Trials Directive (2001/20/EC). This change means that it does not require any national legislation to be implemented, and will be automatically binding in all EU countries.
Streamlining the application process
Unlike the current application process, EU 536/2014 demands only one application to be submitted, despite the fact that multiple EU countries may be involved. To make such process possible, the European Medical Agency will be creating a unified portal (EU Clinical Trial Portal and Database), which will also be available for the public to increase transparency.
Previously, the concept of co-sponsorship was non-existence. Every bit of responsibility of any trial was placed on a single sponsor. EU 536/2014 changes this concept and allows any trial to have one or more sponsors, with all assuming the legal responsibilities unless agreed otherwise.
If you want to find out more on how Clinical Trial Regulation EU 536/2014 will affect clinical trials in the EU, join us in Milan! We are delighted to welcome Massimo Eli from MSD, to unravel this vital regulatory update. The session will be split into 5 key areas:
· Unpacking how this new regulation differs from the current 2001 EU directive and what new demands are placed on sponsors
· Reviewing mechanisms through which you can integrate this regulation into your IRT system to avoid increased information input
· Appreciating how greater accountability will require sponsors to ensure trial reports are more accurately monitored to ensure compliance
· Uncovering if EMA’s relocation will affect the timeline by which this regulation become law
· Evaluating current data integrity regulations needed to minimise data theft risks and compromise your trials
If you wish to find out more on this year’s event programme, please click here: http://www.arena-international.com/Uploads/2017/11/10/q/t/r/CTSEU18_Agenda_v5.pdfalternatively, you can email us at: firstname.lastname@example.org
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