Keyter et al 2020 – Can standardisation of the Public Assessment Report improve benefit-risk communication?

Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as [...]

2020-10-12T10:52:42+00:00June 18th, 2020|Tags: , , |

CIRS RD Briefing 66 – Benefit-Risk Assessment Tool (BRAT)

A structured approach to benefit-risk assessment is required as the cornerstone of a consistent way to evaluate and communicate observations regarding a medicine’s benefit-risk profile. The Benefit Risk Action Team [...]

2020-10-12T10:43:13+00:00January 1st, 2018|Tags: , |

Walker et al 2015 – Universal Framework for the Benefit-Risk Assessment of Medicines

A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, [...]

2020-07-22T10:41:37+00:00January 22nd, 2015|Tags: , |

Liberti et al 2010 – Progress on the development of a benefit-risk framework for evaluating medicines

CIRS authors write about benefit-risk in the March 2010 issue of Regulatory Focus by the Regulatory Affairs Professionals Society (RAPS). Article reproduced with the permission of RAPS. Download [...]

2020-10-12T10:41:12+00:00March 1st, 2010|Tags: , |
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