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Periodic Benefit-Risk Evaluation Report or PBRER is a regulatory document used as a common standard for periodic benefit-risk evaluation reporting on marketed products among the ICH regions. Marketing authorization holders (MAH) prepare PBRER for specific pharmaceutical products needing approval for market release and submit it to regulatory authorities, such as FDA and EMA. A Periodic Benefit-Risk Evaluation Report summarizes analysis of adverse events, new safety concerns, and reviews of the benefit-risk profile of the product. Thus, a PBRER reviews safety and efficacy of a pharmaceutical product through a specified time period. It also reviews changes made to a particular product or in its labeling.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Introduction
Lesson 2: Writing format for PBRER
Lesson 3: Writing content for PBRER
Lesson 4: Writing Conclusion and Appendices