periodic benefit risk evaluation report
- Guideline or reference source
- ICHE2C(R2) Guideline
- Definition
- The main focus of each PBRER is the evaluation of relevant new safety information from the available data sources, placed within the context of any pertinent efficacy/effectiveness information that may have become available since the international birth date, the date of the first marketing approval in any country in the world, or the development international birth date, the date of first authorisation for the conduct of an interventional clinical trial in any country. All pertinent new safety and efficacy/effectiveness information discovered during the reporting interval should be discussed in the appropriate sections of the PBRER. The PBRER should include cumulative knowledge of the product while retaining focus on new information, i.e., the overall safety evaluation and integrated benefit-risk evaluation will take into account cumulative information.
- Abbreviation for
- PBRER
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