Highlights of the workshop “Regulating personalised medicine” organised by the CMR International Institute for Regulatory Science, Nutfield Priory, Surrey, UK, 14-15 April 2003

The unravelling of the human genome and advances in genetic research are now opening up new horizons in medicines research, at the forefront of which is research on the integration of pharmacogenomics (PGx) and pharmacogenetics (PGt) into the discovery and development of new medicines. Such medicines have the potential to be ‘personalised’ or tailored for optimal efficacy and minimal risk in the individual patient.

These developments have implications for pharmaceutical research and regulation that have not yet been fully explored. The impact on practical and economic aspects of drug development and healthcare delivery were discussed at a Workshop convened by the CMR International Institute for Regulatory Science in April 2003 in Nutfield Priory, Surrey, UK.