The new ICH E2C (R2) guideline on Periodic Benefit-Risk Evaluation Reports (PBRERs) reached Step 4 in November 2012 and has already been implemented in the EU under the new Pharmacovigilance legislation. The PBRER is also accepted in the US, Japan, and other countries, and may eventually replace existing requirements for postmarketing periodic reporting in these regions. The new PBRER has significant changes from the previous PSUR format and marks an important step forward towards a document incorporating many new concepts, including an integrated evaluation of both benefits and risks of a medicinal product.

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