Additional risk minimisation measures in the EU- are they eligible for assessment?-Reference-Cited by-同舟云学术

Additional risk minimisation measures in the EU- are they eligible for assessment?

Published:2013-08-15 Issue:10 Volume:22 Page:1046-1053
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Zomerdijk Inge M.¹²,Trifirò Gianluca¹³,Sayed-Tabatabaei Fakhredin A.²,Sturkenboom Miriam C. J. M.¹,Straus Sabine M. J. M.¹²

Affiliation:

1. Departments of Medical Informatics; Erasmus University Medical Centre; Rotterdam The Netherlands

2. Dutch Medicines Evaluations Board; Utrecht The Netherlands

3. Department of Clinical and Experimental Medicine and Pharmacology; University of Messina; Italy

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.3494/fullpdf

Reference20 articles.

1. European Medicine Agency (EMA) Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems 2012 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf

2. Risk minimization activities of centrally authorized products in the EU: a descriptive study;Zomerdijk;Drug Saf,2012

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutifals for Human Use 2004 http://www.ich.org/LOB/media/MEDIA1195.pdf

4. European Commission Directive 2010/84/EU of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human us http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF

5. European Commission Volume 9A of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use 2008 http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf

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