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Getting to grips with the new European Union pharmacovigilance legislation

2011; Wiley; Volume: 20; Issue: 5 Linguagem: Inglês

10.1002/pds.2119

1099-1557

Patrick Waller,

Computational Drug Discovery Methods

Pharmacoepidemiology and Drug SafetyVolume 20, Issue 5 p. 544-549 Commentary Getting to grips with the new European Union pharmacovigilance legislation Patrick Waller, Corresponding Author Patrick Waller [email protected] Patrick Waller Limited, Consultancy in Pharmacovigilance and Pharmacoepidemiology, Rugeley, Staffordshire, UK P. Waller, Patrick Waller Limited, Consultancy in Pharmacovigilance Pharmacoepidemiology 153, Wolseley Road, Rugeley, Staffordshire, WS15 2QT, UK. E-mail: [email protected]Search for more papers by this author Patrick Waller, Corresponding Author Patrick Waller [email protected] Patrick Waller Limited, Consultancy in Pharmacovigilance and Pharmacoepidemiology, Rugeley, Staffordshire, UK P. Waller, Patrick Waller Limited, Consultancy in Pharmacovigilance Pharmacoepidemiology 153, Wolseley Road, Rugeley, Staffordshire, WS15 2QT, UK. E-mail: [email protected]Search for more papers by this author First published: 10 March 2011 https://doi.org/10.1002/pds.2119Citations: 10Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat REFERENCES 1 Fraunhofer Institute for Systems and Innovation Research. Assessment of the European Community System of Pharmacovigilance (2006) see: http://isi.fraunhofer.de/isi-de/t/projekte/medpharm-rt-eurovigilance.php?WSESSIONID=51188dcfdeeba650b433368486c5026b [20 January 2011]. 2 Waller P, Beard K, Egberts T, et al. European Commission consultation on pharmacovigilance. Pharmacoepidemiol Drug Saf 2008; 17: 108–109. 3 The European Commission adopts two legal proposals aimed at amending the EU pharmacovigilance system (10 December 2008); see information and links available at: http://ec.europa.eu/health/human-use/pharmacovigilance/developments/index_en.htm [20 January 2011]. 4 Official Journal of the European Union. 31 December 2010 L. 348/1–16. Regulation 1235/2010 available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF [20 January 2011]. 5 Official Journal of the European Union. 31 December 2010. L. 348/74–99. Directive 2010/84/EU available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF [20 January 2011]. 6Regulation 726/2004; available at: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2004_726_cons/reg_2004_726_cons_en.pdf [20 January 2011]. 7Directive 2001/83/EC; available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf [20 January 2011]. 8EudraLex - Volume 1 - Pharmaceutical Legislation Medicinal Products for Human Use; available at: http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm [20 January 2011]. 9 Medicines and Healthcare products Regulatory Agency. 2008. GSK investigation concludes - see: http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014153 [20 January 2011]. 10 CSM update; Annual review of yellow cards 1985. Br Med J 1986; 293(6548): 688. 11 Practical aspects of signal detection in pharmacovigilance: report of CIOMS working group VIII, 2010; ISBN 9290360828. 12 Moore N, Begaud B. Improving pharmacovigilance in Europe. BMJ 2010; 340: c1694. 13 Statement by Health Action International (2010); available at: http://www.haiweb.org/01102010/30_Sep_2010_Statement_EU_patients_get_a_voice_in_pharmacov.pdf [20 January 2011]. Citing Literature Volume20, Issue5May 2011Pages 544-549 ReferencesRelatedInformation