title: A critique of emerging European legislation in the pharmaceutical industry: a clinical trials analysis.
abstract: The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed inrelation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.
authors.affiliation: Biokinetic Europe Ltd, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Murray
authors.forename: Rodney
authors.initials: R
authors.lastname: McAdam
authors.forename: Moira T
authors.initials: MT
authors.lastname: Burke
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D004341:Drug Evaluation / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D028744:Ethics Committees, Research; D005060:Europe; D005062:European Union; D033161:Government Regulation; D006801:Humans; D009936:Organizational Innovation; D006113:United Kingdom