David R Jones
MHRA Clinical Trials Unit, UK
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
Abstract : The new EU clinical trials regulation