Volume 24, Issue 2 - Risk Management

The changing face of (benefit-)risk management

Author: Lesley Wise

Abstract

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References

1. Florence AL. Is thalidomide to blame? BMJ. 1960;2(5217):1954.
2. McBride WG. Thalidomide and congenital abnormalities. Lancet. 1961;278(7216):1358.
3. Waller P. Introduction to pharmacovigilance. 1st ed. Oxford, UK: Wiley-Blackwell; 2010.
4. About Yellow Card. Medicines and Healthcare Products Regulatory Agency [2014; cited 2014 Jan 26]. Available from: https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
5. To improve worldwide patient safety. Uppsala Monitoring Centre [cited 2014 Jan 26]. Available from: http://www.who-umc.org/
6. Efficacy single. International Conference on Harmonisation [cited 2015 Jan 26]. Available from: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/pharmacovigilance-planning.html
7. Wise L, Parkinson J, Raine J, Breckenridge A. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov. 2009;8(10):779–782.
8. European Commission. Volume 9A of the rules governing medicinal products in the European Union–Guidelines on pharmacovigilance for medicinal products for human use. European Commission [2008; cited 2014 Jan 26]. Available from: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf
9. Giezen TJ, Mantel Teeuwisse AJ, Straus SMJM, Egberts TCG, Blackburn S, Persson I, et al. Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of regulatory approval. Drug Saf. 2009;32(12):1175–1187.
10. Frau S, Font Pous M, Luppino MR, Conforti A. Risk management plans: are they a tool for improving drug safety? Eur J Clin Pharmacol. 2010;66(8):785–90.
11. Good pharmacovigilance practices. Good pharmacovigilance practices. European Medicines Agency [cited 2014 Jan 26]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c
12. Eichler HG, Abadie E, Raine JM, Salmonson T. Safe drugs and the cost of good intentions. N Engl J Med. 2009;360(14):1378–1380.
13. IMI PROTECT. Welcome to the PROTECT benefit-risk website. IMI Protect [cited 2015 Jan 26]. Available from: http://www.imi-protect.eu/benefit-risk.html
14. UMBRA initiative. CIRS [2015; cited 2015 Jan 26]. Available from: http://cirsci.org/UMBRA
15. Revision of M4E guideline on enhancing the format and structure of benefit-risk information in ICH. International Conference on Harmonisation [cited 2014 Jan 26]. Available from: http://www.ich.org/products/ctd/ctdsingle/article/revision-of-m4e-guideline-on-enhancing-the-format-and-structure-of-benefit-risk-information-in-ich.html
16. Guideline on good pharmacovigilance practices (GVP). Module V–Risk management systems (Rev 1). European Medicines Agency and Heads of Medicines Agencies [2014 Apr 15; cited 2015 Jan 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
17. Periodic Benefit-Risk Evaluation Report. International Conference on Harmonisation [cited 2015 Jan 26]. Available from: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/periodic-benefit-risk-evaluation-report.html
18. Guideline on good pharmacovigilance practices (GVP). Module VII–Periodic safety update report (Rev 1). European Medicines Agency and Heads of Medicines Agencies [2013 Dec 9; cited 2015 Jan 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf
19. Guideline on good pharmacovigilance practices (GVP). Module IX–Signal management. European Medicines Agency and Heads of Medicines Agencies [2012 Jun 22; cited 2015 Jan 26]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129138.pdf
20. Greenstone G. The revival of thalidomide: from tragedy to therapy. BCMJ. 2011;53(5):230–233.