A critique of emerging European legislation in the pharmaceutical industry: A clinical trials analysis

Elizabeth Murray, Rodney McAdam, Moira T. Burke

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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 in relation 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.

Original languageEnglish
Pages (from-to)389-393
Number of pages5
JournalInternational Journal of Health Care Quality Assurance
Volume17
Issue number7
DOIs
Publication statusPublished - 2004

Bibliographical note

Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.

Keywords

  • Clinical medicine
  • European union information
  • Organizational change
  • Pharmaceuticals industry
  • Research organizations

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