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

Margaret R Warner1, Anne M Wolka1, Rebecca A Noel1

  • 11 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.

Therapeutic Innovation & Regulatory Science
|September 19, 2018
PubMed
Abstract

Keywords:
International Conference on Harmonisation (ICH)Periodic Benefit-Risk Evaluation Report (PBRER)benefit-risk assessmentbenefit-risk frameworkperiodic safety update report (PSUR)

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