Barriers and Opportunities for Use of Patient Registries in Medicines Regulation

Author:

Olmo Carla Alonso1,McGettigan Patricia12,Kurz Xavier1

Affiliation:

1. Pharmacovigilance and Epidemiology DepartmentEuropean Medicines Agency Amsterdam The Netherlands

2. William Harvey Research InstituteQueen Mary University of London London UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference10 articles.

1. European Medicines Agency.EMA patient registries initiative. Accessed February 15 2019.

2. EMA Cross‐Committee Task Force on Patient Registries.Discussion paper: use of patient disease registries for regulatory purposes – methodological and operational considerations (November 5 2018). Accessed February 15 2019.

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

4. Registries supporting new drug applications

5. European Medicines Agency.Patient Registries Workshop 28 October 2016. Observations and recommendations arising from the workshop (February 13 2017). Accessed February 15 2019.

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