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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

 

120 minutes
Online based learning
English language
Certificate of Achievement
500 €
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AUTHORS

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Prof. Olaf Klungel

Utrecht Universiteit

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Dr. George Quartey

F. Hoffmann-La Roche Ltd




COMPANIES OFFER

Short courses can be included in a training package for your team!


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+33 5 47 30 42 69

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