Definition

Periodic report (e.g., annually) summarizing benefit-risk of a medicine; replaces PADER in EU. Includes safety analyses and signal evaluation.

Example

Annual PBRER submitted to EMA and FDA with cumulative safety data.

Regulatory source

ICH E2C(R2), GVP Module VII

Common mistakes

Cut-paste from previous PBRER without re-evaluation.

Inspector question

How do you ensure each PBRER reflects current benefit-risk?

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