Although several approaches for qualitative and quantitative benefit risk management have been discussed for several years, their application in everyday practice remains scarce. This is particularly astonishing as with the move of PSURs to the PBRER format, a systematic evaluation of the Benefit Risk profile of every drug should be performed.

This course aims to provide an opportunity to explore different methods in order to foster a more frequent and systematic utilisation of methods enhancing the transparency around Benefit Risk decision making. We will introduce methods for the analysis of risk factors contributing to the development of (potential) risks (Zurich Hazard Analysis, Fault Tree Analysis), the analysis of risks associated with medication processes leading to potential medication errors (Failure Modes and Effects Analysis), Qualitative Benefit Risk frameworks, as well as discuss the possible uses for Quantitative Benefit Risk analysis methods. Suitable examples for all methods will be used to show the strengths as well as the limitations of the methodologies discussed.