#3 -ICH E2C (R2); The Quantum Leap from PSURs to Benefit Risk Evaluation (PBRERs)

The new ICH E2C (E2C) guideline on Periodic Benefit Risk Evaluation Reports reached Step 2 in February 2012 and completed Step 4 in November 2012. Already implemented in the EU under the new Pharmacovigilance legislation, this new report represents a significant change from the previous PSUR format and a quantum leap forward towards a document incorporating many new concepts including an integrated evaluation of both benefits and risks of a medicinal product .In the other ICH regions, the PBRER is intended to replace existing requirements for post marketing periodic reporting.

At the conclusion of this activity, participants should be able to:

• Discuss the main principles defined in the ICH E2C (R2) guideline
• Describe the structure and content of the new PBRER
• Explain regulatory authority expectations of the PBRER
• Recognize how to implement the PBRER to encompass multiple functions
• Discuss the practical aspects of preparation of the PBRER