Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
David R Jones
MHRA Clinical Trials Unit, UK
Posters & Accepted Abstracts: J Clin Trials
The EU is introducing legislation aimed at harmonizing the way in which clinical trials conducted in the Europe are authorized and at improving the reliability of data generated in those trials. The Regulation replaces the EU Clinical Trials Directive (EUCTD), which was approved in 2001 and implemented in May 2004. The regulation will introduce and include a number of key provisions. There is an authorization procedure for clinical trials based on a single submission dossier via a single EU portal, an assessment procedure leading to a single decision on all aspects per member state, rules on the protection of subjects and informed consent, and transparency requirements. Other aspects include more detailed safety provisions, new indemnity provisions and a category for low interventional trials. The new regulation also intends to make it easier for Pharma companies to conduct multinational clinical trials. The talk will cover review the new Regulation, highlighting what will change from the Directive and advise companies how to gear up for its implementation.
Email: david.jones@mhra.gsi.gov.uk