Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report-Reference-Cited by-同舟云学术

Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report

Published:2016-05 Issue:3 Volume:50 Page:342-346
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Warner Margaret R.,Wolka Anne M.,Noel Rebecca A.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479015609650.pdf

Reference12 articles.

1. European Medicines Agency (EMA). ICH Topic E2C(R1), Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002780.pdf. Accessed August 11, 2015.

2. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline, Periodic Benefit-Risk Evaluation Report (PBRER) E2C (R2), 2012. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_Step4.pdf. Accessed August 11, 2015.

3. European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Module VII — Periodic safety update report (Rev 1). 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf. Accessed August 11, 2015.

4. International Conference on Harmonisation. E2C(R2) Implementation Working Group ICH E2C(R2) Guideline: Periodic Benefit-Risk Evaluation Report Questions & Answers, 2014. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_QAs_Step4.pdf. Accessed August 11, 2015.

5. European Medicines Agency (EMA). Benefit-risk methodology project. Work package 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network. London: EMA; 2009. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109478.pdf. Accessed August 11, 2015.

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