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Drug Safety

, Volume 10, Issue 2, pp 93–102 | Cite as

Harmonisation in Pharmacovigilance

  • I. Ralph Edwards
  • Cecilia Biriell
Leading Article

Keywords

Adverse Drug Reaction International Drug Monitoring Adverse Drug Reaction Monitoring World Health Organization Collaborate Adverse Drug Reaction Data 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

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  2. Council for International Organizations of Medical Sciences. International reporting of adverse drug reactions, CIOMS, Geneva, 1990Google Scholar
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  4. European Commission. CPMP Working Party. Notes for guidance 111/3976/88-EN. European Commission, Brussels, 1988Google Scholar
  5. European Commission. Notice to applicants III73567/92, pp. 125–126, Brussels, 1993Google Scholar
  6. International Committee on Harmonization. Clinical safety data management: definitions and standards for expedited reporting ICH-2 EWG E2, in press, 1994Google Scholar
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  8. Leon DA. Failed or misleading adjustment for confounding. Lancet 342: 479–481, 1993PubMedCrossRefGoogle Scholar
  9. Stephens MDB. Detection of new adverse drug reactions, 3rd ed., Macmillan Publishers Ltd, Basingstoke, 1992Google Scholar
  10. Waller PC, Wood SM, Langman MJS, Breckenridge AM, Rawlins MD. Review of company post-marketing studies. British Medical Journal 304: 1470–1472, 1992PubMedCrossRefGoogle Scholar
  11. World Health Organization. Technical Report Series No 498, World Health Organization, Geneva, 1972Google Scholar

Copyright information

© Adis International Limited 1994

Authors and Affiliations

  • I. Ralph Edwards
    • 1
  • Cecilia Biriell
    • 1
  1. 1.WHO Collaborating Centre for International Drug MonitoringUppsalaSweden

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