Overview of the <scp>European post‐authorisation study</scp> register post‐authorization studies performed in Europe from September 2010 to December 2018-Reference-Cited by-同舟云学术

Overview of the European post‐authorisation study register post‐authorization studies performed in Europe from September 2010 to December 2018

Published:2022-02-11 Issue:6 Volume:31 Page:689-705
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiology and Drug

Author:

Sultana Janet¹²,Crisafulli Salvatore³,Almas Mariana⁴,Antonazzo Ippazio Cosimo⁵⁶,Baan Esme⁷,Bartolini Claudia⁶,Bertuccio Maria Paola³,Bonifazi Fedele⁸⁹,Capuano Annalisa¹⁰¹¹,Didio Antonella⁸⁹,Ehrenstein Vera¹²^ORCID,Felisi Mariagrazia⁸¹³,Ferrajolo Carmen¹⁰¹¹,Fontana Andrea¹⁴,Francisca Remy⁷,Fourrier‐Reglat Annie¹⁵,Fortuny Joan¹⁶,Gini Rosa⁶^ORCID,Hyeraci Giulia⁶,Hoeve Christel⁷,Kontogiorgis Christos¹⁷^ORCID,Isgrò Valentina¹⁸,Lalagkas Panagiotis‐Nikolaos¹⁷,L'Abbate Luca¹⁸,Layton Deborah¹⁹,Landi Annalisa⁸⁹,Narduzzi Silvia¹⁹,Roque Pereira Leonardo²⁰,Poulentzas Georgios¹⁷,Rafaniello Concetta¹⁰¹¹,Roberto Giuseppe⁶^ORCID,Scondotto Giulia³,Sportiello Liberata¹⁰¹¹,Toma Maddalena⁸⁹,Toussi Massoud¹⁹,Verhamme Katia⁷,Volpe Elisabetta⁸⁹,Trifirò Gianluca¹⁸,

Affiliation:

1. Pharmacy Department Mater Dei Hospital Msida Malta

2. Exeter College of Medicine and Health Exeter UK

3. Department of Medicine University of Verona Verona Italy

4. Real World Solutions Department IQVIA Lisbon Portugal

5. Research Centre on Public Health (CESP) University of Milan‐Bicocca Milan Italy

6. Agenzia Regionale di Sanità della Toscana Florence Italy

7. Department of Medical Informatics Erasmus Medical Centre Rotterdam The Netherlands

8. TEDDY European Network of Excellence for Paediatric Clinical Research Pavia Italy

9. Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus Bari Italy

10. Department of Experimental Medicine University of Campania "Vanvitelli" Naples Italy

11. Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology Naples Italy

12. Department of Clinical Epidemiology Aarhus University Hospital Aarhus Denmark

13. CVBF Consorzio per Valutazioni Biologiche e Farmacologiche Pavia Italy

14. Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo Italy

15. Univ. Bordeaux, INSERM, Bordeaux Population Health Research Center Team of Pharmacoepidemiology, UMR 1219 Bordeaux France

16. RTI Health Solutions Barcelona Spain

17. Democritus University of Thrace Alexandroupolis Greece

18. Department of Diagnostics and Public Health University of Verona Verona Italy

19. Data Science Hub Real World Solutions, IQVIA London UK

20. Department of Datascience & Biostatistics University Medical Center Utrecht Utrecht The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5413

Reference12 articles.

1. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. The European Union electronic Register of Post‐Authorisation Studies (EU‐PAS Register). Accessed August 31 2021.http://www.encepp.eu/encepp_studies/indexRegister.shtml

2. European Medicines Agency. GVP Module VIII; 2017. Accessed August 31 2021.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-3_en.pdf

3. Lessons learned on the design and the conduct of Post‐Authorization Safety Studies: review of 3 years of PRAC oversight

4. An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

5. A review of studies evaluating the effectiveness of risk minimisation measures in Europe using the European Union electronic Register of Post-Authorization Studies

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