Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union

Author:

Patel Hina,Ton Thanh G. N.,Davies Jessica,Fear Simon,Block Carolin,Tanaka Kunihiko,Gonzalez Danny,Mutter Roger,Alfaro-Oliver Noelia,Mendez Ignacio,Qizilbash Nawab

Funder

F. Hoffmann-La Roche

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference19 articles.

1. 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. Accessed 15 Apr 2021.

2. EphMRA. Code of conduct. 2017. https://www.ephmra.org/media/1785/ephmra-2017-code-of-conduct-october-2017.pdf. Accessed 15 Apr 2021.

3. 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. Accessed 15 Apr 2021.

4. Draugalis JR, Coons SJ, Plaza CM. Best practices for survey research reports: a synopsis for authors and reviewers. Am J Pharm Educ. 2008;72(1):11. https://doi.org/10.5688/aj720111.

5. American Association for Public Opinion Research (AAPOR). Standard definitions: final dispositions of case codes and outcome rates for surveys (9th ed.). 2016. http://www.aapor.org/AAPOR_Main/media/publications/Standard-Definitions20169theditionfinal.pdf. Accessed 9 Nov 2021.

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