This course gives you an introduction into the principles and methods of comparative Benefit-Risk assessment and their role of benefit-risk assessment in decision-making of medicines.

This course focuses on the different qualitative frameworks and basic quantitative methods for Benefit-Risk assessment, including their potentials and limitations.

At the end of the course, you will be able to :

• Explain definition of benefit and risk in EMA framework
• Explain the rationale of BR frameworks and quantitative approaches in the process of decision-making (transparency, consistency, objectivity)
• Distinguish the most important BR frameworks and their key components
• Describe what BR Modeling and BR profiling is and define differences between these approaches
• Describe basic methods and outcomes of quantitative BR assessment and present merits and demerits of each approach