Advanced search
Publication Cover
Expert Review of Clinical Pharmacology Volume 5, 2012 - Issue 5
Submit an article Journal homepage
111
Views
4
CrossRef citations to date
0
Altmetric
Editorial

Pharmacovigilance in Europe: direction of travel in a changing environment

Ana Hidalgo-Simon European Medicines Agency, 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK. [email protected]
&
Peter Arlett European Medicines Agency, 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Pages 485-488 | Published online: 10 Jan 2014

References

  • Arlett PR, Kurz X. New approaches to strengthen pharmacovigilance. Drug Discov. Today Technol 8(1), 15–19 (2011).
  • Raine J, Wise L, Blackburn S, Eichler HG, Breckenridge A. European perspective on risk management and drug safety. Clin. Pharmacol. Ther. 89(5), 650–654 (2011).
  • Eichler HG, Oye K, Baird LG et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91(3), 426–437 (2012).
  • Aronson JK, Hauben M, Bate A. Defining ‘surveillance’ in drug safety. Drug Saf. 35(5), 347–357 (2012).
  • Lounkine E, Keiser MJ, Whitebread S et al. Large-scale prediction and testing of drug activity on side-effect targets. Nature 486(7403), 361–367 (2012).
  • Liberti L, Breckenridge A, Eichler HG, Peterson R, McAuslane N, Walker S. Expediting patients’ access to medicines by improving the predictability of drug development and the regulatory approval process. Clin. Pharmacol. Ther. 87(1), 27–31 (2010).
  • Sistare FD, Dieterle F, Troth S et al. Towards consensus practices to qualify safety biomarkers for use in early drug development. Nat. Biotechnol. 28(5), 446–454 (2010).
  • Eichler HG, Aronsson B, Abadie E, Salmonson T. New drug approval success rate in Europe in 2009. Nat. Rev. Drug Discov. 9(5), 355–356 (2010).
  • Eichler HG, Abadie E, Raine JM, Salmonson T. Safe drugs and the cost of good intentions. N. Engl. J. Med. 360(14), 1378–1380 (2009).
  • Eichler HG, Bloechl-Daum B, Abadie E, Barnett D, König F, Pearson S. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat. Rev. Drug Discov. 9(4), 277–291 (2010).
  • Regnstrom J, Koenig F, Aronsson B et al. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur. J. Clin. Pharmacol. 66(1), 39–48 (2010).
  • Blake KV, Prilla S, Accadebled S et al. European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol. Drug Saf. 20(10), 1021–1029 (2011).
  • Prieto L, Spooner A, Hidalgo-Simon A, Rubino A, Kurz X, Arlett P. Evaluation of the effectiveness of risk minimization measures. Pharmacoepidemiol. Drug Saf. 21(8), 896–899 (2012).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.