European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance-Reference-Cited by-同舟云学术

European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

Published:2011-08-17 Issue:10 Volume:20 Page:1021-1029
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Blake Kevin V.¹,Prilla Stefanie¹,Accadebled Sophie¹,Guimier Marie¹,Biscaro Monica¹,Persson Ingemar²³,Arlett Peter¹,Blackburn Stella¹,Fitt Henry¹

Affiliation:

1. Pharmacovigilance and Risk Management Sector, Patient Health Protection Unit; European Medicines Agency; London UK

2. Medical Products Agency; Uppsala Sweden

3. Centre for Pharmacoepidemiology; Karolinska Institute; Stockholm Sweden

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.2209/fullpdf

Reference11 articles.

1. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use http://ec.europa.eu/health/files/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf

2. 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/documents/eudralex/vol-9/index_en.htm

3. ICH Harmonised Tripartite Guideline Pharmacovigilance Planning E2E 2004 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf

4. Rosiglitazone: what went wrong?;Cohen;BMJ,2010

5. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. What is ENCePP? 2011 http://www.encepp.eu/structure/index.html

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