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