Guidance Document - Periodic Benefit-Risk Evaluation Report (PBRER) International Conference on Harmonisation (ICH) Topic E2C(R2) (English, HTML)

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Publisher-reported update

2021-07-07

The Periodic Benefit-Risk Evaluation Report (PBRER) described in this Guideline is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the International Conference on Harmonisation (ICH) regions. This Guideline defines the recommended format and content of a PBRER and provides an outline of points to be considered in its preparation and submission.

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