Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021-Reference-Cited by-同舟云学术

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

Published:2023-09-02 Issue:10 Volume:46 Page:1007-1020
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Essink Sharon C. M.^ORCID,Zomerdijk Inge M.,Straus Sabine M. J. M.,Gardarsdottir Helga^ORCID,De Bruin Marie L.^ORCID

Funder

College ter Beoordeling van Geneesmiddelen

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

https://link.springer.com/content/pdf/10.1007/s40264-023-01341-0.pdf

Reference25 articles.

1. Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies. Drug Saf. 2015. https://doi.org/10.1007/s40264-015-0281-0.

2. Regulation (EC) No 726/2004 of the European Parliament and of the Council of March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

3. European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP): Module V—Risk management systems (Rev 2). 2017.

4. European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2). 2017.

5. Francisca RDC, Zomerdijk IM, Sturkenboom M, Straus S. Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures. Expert Opin Drug Saf. 2018. https://doi.org/10.1080/14740338.2018.1512579.