Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder-Reference-Cited by-同舟云学术

Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder

Published:2022-04-13 Issue:3 Volume:36 Page:173-188
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Hapani Kalindi^ORCID,Parikh Nipa,Pianka Krystle,Patel Harshil

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

https://link.springer.com/content/pdf/10.1007/s40290-022-00426-y.pdf

Reference15 articles.

1. Council for international Organizations of Medical Sciences (CIOMS). Practical approaches to risk minimisation for medicinal products: report of CIOMS Working Group IX. 2014. Geneva, Switzerland. 2014. Available from: https://cioms.ch/publications/product/practical-approaches-to-risk-minimisation-for-medicinal-products-report-of-cioms-working-group-ix/. [Accessed 22 Jun 2021].

2. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI: risk minimisation measures: selection of tools and effectiveness indicators (Rev 2). 2017. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xvi-risk-minimisation-measures-selection-tools_en-3.pdf. [Accessed 22 Jun 2021].

3. The European Parliament and the Council of the European Union. Directive 2001/83/EC of the European Parliament and of the Council. 2001. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf. [Accessed 22 Jun 2021].

4. European Medicines Agency. PRAC strategy on measuring the impact of pharmacovigilance activities (Rev 1). 2017. Available from: https://www.ema.europa.eu/en/documents/other/prac-strategy-measuring-impact-pharmacovigilance-activities_en.pdf. [Accessed 22 Jun 2021].

5. Eccles MP, Mittman BS. Welcome to implementation science. Implement Sci. 2006;1:1. https://doi.org/10.1186/1748-5908-1-1.