EU legal representation for clinical trials
This area is in the process of major change with the implementation of the Clinical Trials Regulation No.536/2014. As this is a regulation, it has not until now required translation into UK law. If the UK chooses to follow the Swiss model, this translation would need to occur when the UK leaves the EU. This regulation is due to be implemented sometime during 2019, around the same time or after the UK formally leaves the EU on 29 March 2019.
After Brexit only entities based in the EU/EEA may act as a sponsor and/or legal representative of the sponsor for conducting clinical trials at sites within EU/EEA.
Pharmaconsult will provide the legal representative to sponsor trials for EU or UK as required.
For further details please contact firstname.lastname@example.org