Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013-Reference-Cited by-同舟云学术

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013

Published:2017-03-26 Issue:12 Volume:26 Page:1442-1450
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Bouvy Jacoline C.¹²^ORCID,Blake Kevin¹^ORCID,Slattery Jim¹^ORCID,De Bruin Marie L.²³^ORCID,Arlett Peter¹^ORCID,Kurz Xavier¹^ORCID

Affiliation:

1. Department of Pharmacovigilance and Epidemiology; European Medicines Agency; London UK

2. Utrecht Institute for Pharmaceutical Sciences; Utrecht University; Utrecht The Netherlands

3. Copenhagen Centre for Regulatory Science; University of Copenhagen; Copenhagen Denmark

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.4196/fullpdf

Reference19 articles.

1. European Medicines Agency review of post-authorisation studies with implications for the European network of centres for pharmacoepidemiology and pharmacovigilance;Blake;Pharmacoepidemiol Drug Saf,2011

2. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 http://ec.europa.eu/health/files/eudralex/vol-1/reg_2010_1235/reg_2010_1235_en.pdf

3. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf

4. PARENT Joint Action Methodological Guidelines and Recommendations for Efficient and Rational Governance of Patient Registries 2015 http://patientregistries.eu/deliverables

5. Agency for Healthcare Research and Quality Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=1897 2017

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