DIA Europe 2019

Component Type: Tutorial

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 utilization 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.

Who should attend?

Primary audience is in Clinical Safety/Pharmacovigilance with experience in risk management planning and execution.. Also for professionals working in Clinical Research, Research & Development, Regulatory Affairs and/or Quality Assurance/Quality Control.

Learning Objectives

Understand the relative advantages/disadvantages of different methods in (benefit)-risk management in order to apply the most suitable approach for a given situation Get basic experience in the hands-on performance of various types of benefit-risk analyses to be able to critically evaluate results from such exercises Learn how to use the results from such analyses in Benefit-Risk communication