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

Jan 12 2014 1:30PM - Jan 12 2014 5:00PM

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Overview 

The new ICH E2C (E2C) guideline on Periodic Benefit-Risk Evaluation Reports (PBRERs) reached Step 4 in November 2012, and has already implemented in the EU under the new Pharmacovigilance legislation. Also accepted in the US, Japan and other countries, the PBRER may replace existing requirements for post marketing periodic reporting.  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.

Learning Objectives 

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 the regulatory authority expectations of the PBRER
  • Recognize some of the key implementation challenges and how they may be addressed
  • Discuss the practical aspects in the preparation of the PBRER

Instructor(s) 

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Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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