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David R Jones

MHRA Clinical Trials Unit, UK

Title: The new EU clinical trials regulation

Biography

David R Jones, BSc, MSc, EurBiol, CBiol, MRSB, MTOPRA, European Registered Toxicologist After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996. My current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological. A further aspect of my job is to offer regulatory advice to companies on behalf of the MHRA or the EU’s Committee for Human Medicinal Products (CHMP). I am one of the UK’s accredited non-clinical experts to support the CHMP and am the UK representative on the EU’s Safety Working Party (SWP). I represented the EU in the ICH revision of the M3 Guideline and on the ICH S10 Guideline. I am now EU Rapporteur on the new ICH S11 (Juvenile Animal Studies) guideline and the Q&A document for ICH S3 (Toxicokinetics). I am also a guest lecturer at the University of Surrey, the University of Wales, and the University of Leicester and a frequent presenter at conferences around the world.

Abstract

The EU is introducing legislation aimed at harmonising the way in which clinical trials conducted in the Europe are authorised 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 authorisation 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.