Risk Minimisation Evaluation with Process Indicators and Behavioural or Health Outcomes in Europe: Systematic Review

Author:

Artime EstherORCID,Qizilbash Nawab,Herruzo Rafael,Garrido-Estepa Macarena

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference39 articles.

1. Rubino A, Artime E. A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006–2015. Expert Opin Drug Saf. 2017;16:877–84.

2. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VIII: post-authorisation safety studies (Rev 2). 2016. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-2_en.pdf

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

4. Rubino A, Artime E. A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006-2015. Expert Opin Drug Saf. 2017; p. 1–8.

5. Artime E, Qizilbash N, Garrido-Estepa M, Vora P, Soriano-Gabarró M, Asiimwe A, et al. Are risk minimization measures for approved drugs in Europe effective? A systematic review. Expert Opin Drug Saf. 2019;18:443–54.

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