Tag Archive
The following is a list of all entries tagged with Clinical Trials Directive:
Drug Regulator, MHRA, Publishes an Updated Guide for Manufactures on Clinical Investigations to be Carried out in the UK
Filed in clinical, regulatory, January 6, 2010, 8:26 amThe Medical Devices Regulations 2002 (SI No 618), as amended by the Medical Devices (Amendment) Regulations 2008, came into force on 13 June 2002 and implement the provisions of the Medical Devices Directive 93/42/EEC (as amended by Directive 2007/47/EC), the Active Implantable Medical Devices Directive 90/385/EEC (as amended by Directive 2007/47/EC) and the In Vitro Diagnostic Medical Devices Directive 98/79/EEC. These Regulations establish systems under which a manufacturer must submit to the UK Competent Authority, information about clinical investigations of medical devices to be carried out in the UK.
European Commission Publishes Assessment of the Functioning of the Clinical Trials Directive
Filed in clinical, report, November 22, 2009, 12:35 pmThis assessment would consider, in particular, various options for further improving the functioning of the Clinical Trials Directive with a view to remedy shortcomings and unintended negative consequences while taking the global dimension of clinical trials into account.
The Impact of the Clinical Trails Directive
Filed in clinical, regulatory, July 6, 2009, 9:01 amThe impact of the clinical trials directice on clinical drug development has been evaluated by ICREL (Impact of Clinical Research of European Legislation) who have just published their report (HEALTH-F1-2007-201002)
Entries