Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators-Reference-Cited by-同舟云学术

Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators

Published:2018-05-11 Issue:7 Volume:27 Page:823-826
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Pacurariu Alexandra¹²^ORCID,Plueschke Kelly¹,Olmo Carla Alonso¹,Kurz Xavier¹^ORCID

Affiliation:

1. Surveillance & Epidemiology Service; European Medicines Agency (EMA); London UK

2. Medical Informatics Department; Erasmus Medical Centre; Rotterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference10 articles.

1. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013;Bouvy;Pharmacoepidemiol Drug Saf,2017

2. Registries supporting new drug applications;Jonker;Pharmacoepidemiol Drug Saf,2017

3. A systematic assessment of key design and performance characteristics of drug exposure registries requested by the U.S. Food and Drug Administration;Zhao;Pharmacoepidemiol Drug Saf,2018

4. EMA Initiative for patient registries [Internet] 2015 http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/10/WC500195576.pdf

5. European Commision Commission Implementing Regulation 520/2012 [Internet] https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2012_520/reg_2012_520_en.pdf

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