Good pharmacovigilance practice and the curates egg

Drug Safety

Volumn 35, Issue 6, 2012, Pages 429-435

  Edwards, I Ralph ^a  

^a UPPSALA MONITORING CENTRE   (Sweden)

Author keywords

European Medicines Agency; Pharmacovigilance

Indexed keywords

CLINICAL DECISION MAKING; DRUG LEGISLATION; DRUG MONITORING; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; HUMAN; INFORMATION PROCESSING; MASS MEDIUM; OCCUPATIONAL EXPOSURE; PRIORITY JOURNAL; PROPHYLAXIS; PUBLIC HEALTH SERVICE; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; STATISTICAL ANALYSIS; WORLD HEALTH ORGANIZATION;

EUROPEAN UNION; HUMANS; PHARMACOVIGILANCE; PRACTICE GUIDELINES AS TOPIC;

EID: 84861367388     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11634410-000000000-00000     Document Type: Review

References (15)

1. European Medicines Agency. European Medicines Agency releases good pharmacovigilance practice modules for public consultation [online].Available fromURL: http://www. ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/ news/2012/02/news-detail-001451.jsp&mid=WC0b01ac0580 04d5c1&jsenabled= true [Accessed 2012 Apr 24]
2. The European Parliament and the Council of the European Union. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use [online]. Available from URL: http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099: EN:PDF [Accessed 2012 May 3]
3. The European Parliament and the Council of the European Union. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ: L:2010:348:0001:0016: EN:PDF [Accessed 2012 May 3]
4. European Medicines Agency, Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP): module II-pharmacovigilance system master file [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2012/02/WC500 123206.pdf [Accessed 2012 May 4]
5. US FDA. Guidance for industry: Good pharmacovigilance practices and pharmacoepidemiologic assessment [online]. Available from URL: http://www.fda.gov/ohrms/DOCK ETS/ac/05/briefing/2005-4136b1-02-Good%20Pharmaco vigilance%20Practices.pdf [Accessed 2012 May 4]
6. Volume 9A of the rules governing medicinal products in the European Union: guidelines on pharmacovigilance for medicinal products for human use [online]. Available from URL: http://ec.europa.eu/health/files/eudralex/vol-9/ pdf/vol9a-09-2008-en.pdf [Accessed 2012 May 4]
7. European Medicines Agency. Guidelines on good pharmacovigilance practices (GVP): introductory cover note to the public consultation of the first seven modules [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/ document-library/Other/2012/02/WC500123145.pdf [Accessed 2012 May 4]
8. Edwards IR. An agenda for UK clinical pharmacology pharmacovigilance. Br J Clin Pharmacol. Epub 2012 Feb 23
9. Goldacre B. Dithering over statins' side-effects label finally ends [online]. Available from URL: http://www.guardian. co.uk/commentisfree/2009/nov/ 21/statins-side-effects-bengoldacre [Accessed 2012 Apr 24]
10. Rubin R. How did Vioxx debacle happen? [online]. Available from URL: http://www.usatoday.com/news/health/2004-10-12-vioxx-cover-x.htm [Accessed 2012 Apr 24]
11. Wilson RM, Michel P, Olsen S, et al. Patient safety in developing countries: retrospective evaluation of scale and nature of harm to patients in hospital. BMJ 2012; 344: e832
12. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004; 329: 15-9 (Pubitemid 38869995)
13. European Medicines Agency. Good pharmacovigilance practices [online]. Available from URL: http://www.ema. europa.eu/ema/index.jsp?curl=pages/ regulation/document-listing/document-listing-000345.jsp&mid=WC0b01ac058 04fcdb1 [Accessed 2012 May 8]
14. European Medicines Agency, Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP): module IX-signal management [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2012/02/WC500123209.pdf [Accessed 2012 May 14]
15. Montero D, De Lisa R. The PRAC-Pharmacovigilance Risk Assessment Committee [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/ document-library/Presenta tion/2011/06/WC500108031.pdf [Accessed 2012 Apr 24]