FUNDAMENTALS OF QUANTITATIVE BENEFIT-RISK ASSESSMENT METHODS IN DECISION MAKING ON MEDICINES
Decision making on medicines informed by quantitative benefit-risk assessment may differ depending on the perspective of the decision maker and the phase of drug development. This module will address the decision-making on medicines by different stakeholders during the life cycle of a drug and how benefit-risk assessment tools may be applied in this process. Principles and fundamental methodologies for quantitative benefit/risk assessment, the strengths and weaknesses of these methodologies, and how to apply these methodologies in practice, will be discussed.
At the end of this module, you will be able to:
Describe principles and methods of comparative BR assessment
Apply different fundamental quantitative B-R assessment methods in an example case
Interpret results of quantitative B-R assessment and translate the results into the process of decision making
Evaluate the results of quantitative B-R assessment and identify limitations of B-R methods
Coordinator: Dr Jet Van Der Zijden (from Universiteit Utrecht)
Expert(s): Prof Olaf Klungel, Prof Toine Pieters, Dr Daniala Weir (from Universiteit Utrecht).
Applications open until December 11th, 2022
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