Principles and methods of benefit-risk assessment in decision-making of medicines
OBJECTIVES
This course gives you an introduction into the principles and methods of comparative Benefit-Risk assessment and their role in the process of decision making. It focuses on the different qualitative frameworks and basic quantitative methods for Benefit-Risk assessment, including their potentials and limitations.
Qualitative & Quantitative B-R Measurement, Benefit-Risk Methodologies, European Medicines Agency
LEARNING OUTCOMES
At the end of this 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