A Description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a Global Resource for Pharmacovigilance and Pharmacoepidemiology

Mann's Pharmacovigilance: Third Edition

Volumn , Issue , 2014, Pages 403-408

  Goedecke, Thomas ^a   Arlett, Peter ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Code of conduct; ENCePP; Pharmacoepidemiology; Pharmacovigilance; Post authorization studies; Research standard; Resource database

Indexed keywords

EID: 84926435409     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118820186.ch24     Document Type: Chapter

References (5)

1. EU (2010a) 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 and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.
2. EU (2010b) 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.
3. HMA/EMEA (2007) European Risk Management Strategy: 2008-2009 work programme adopted. Heads of Medicines Agencies/European Medicines Agency. URL http://www.hma.eu/uploads/media/ERMS_2008-2009_work_programme_adopted.pdf.
4. ISPE (2008) Guidelines for Good Pharmacoepidemiology Practices (GPP). International Society for Pharmacoepidemiology.
5. Von Elm, E, Altman, D.G., Egger, M. et al. (2008) STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol, 61 (4), 344-349.