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

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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Title (French)	Ligne directrice - Rapport périodique d'évaluation des avantages et des risques (RPEAR) International Conference on Harmonisation (ICH) thème E2C(R2)
Update Frequency	as_needed
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Sensitivity Level	unrestricted
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Open Canada Date Published	2013-09-17 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["Document d'orientation", "rapport d'évaluation périodique bénéfice-risque", "PBRER", "International Conference on Harmonisation", "ICH", "Topic E2C(R2)", "reporting sur les produits commercialisés"], "en": ["Guidance document", "periodic benefit-risk evaluation report", "PBRER", "International Conference on Harmonisation", "ICH", "Topic E2C(R2)", "reporting on marketed products"]}
Open Canada Collection	publication
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