Definition

A structured evaluation in periodic reports weighing the therapeutic benefits against known and emerging risks to conclude on overall product value.

Example

The PBRER concludes: 'Despite the newly identified hepatotoxicity risk (estimated 1:10,000), the product's proven efficacy in reducing mortality in severe disease maintains a favorable benefit-risk balance with enhanced monitoring.'

Regulatory source

ICH E2C(R2)

Common mistakes

Providing vague benefit-risk conclusions without specific supporting data and reasoning.

Inspector question

Walk me through your benefit-risk analysis methodology. How do you quantify and weigh factors?

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