Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review-Reference-Cited by-同舟云学术

Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review

Published:2020-02-04 Issue:5 Volume:43 Page:427-446
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Russell Andrea M.^ORCID,Morrato Elaine H.,Lovett Rebecca M.,Smith Meredith Y.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

http://link.springer.com/content/pdf/10.1007/s40264-020-00905-8.pdf

Reference78 articles.

1. Fontanarosa PB, Rennie D, De Angelis CD. Postmarketing surveillance—lack of vigilance, lack of trust. JAMA. 2004;292:2647–50.

2. Food and Drug Administration Amendments Act (FDAAA) of 2007.

3. European Medicines Agency. ICH Topic E 2 E Pharmacovigilance Planning (Pvp) London: European Medicines Agency; 2005. https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-25.pdf. Accessed 10 Dec 2019.

4. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module XVI–Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2). London: European Medicines Agency; 2012–2017. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162051.pdf. Accessed 27 Sep 2019.

5. Council for International Organizations of Medical Sciences (CIOMS). Practical approaches to risk minimisation for medicinal products: report of CIOMS Working Group IX. Geneva: Council for International Organizations of Medical Sciences (CIOMS); 2014.

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies;Drug Safety;2024-04-09

2. The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE);Drug Safety;2024-03-13

3. Prenatal exposure to teratogenic medications in the era of Risk Evaluation and Mitigation Strategies;American Journal of Obstetrics and Gynecology;2022-08

4. Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018);BMC Health Services Research;2021-08-06

5. Comparative analysis of the use and control of thalidomide in Brazil and different countries: is it possible to say there is safety?;Expert Opinion on Drug Safety;2021-07-15