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FUNDAMENTALS OF QUANTITATIVE BENEFIT-RISK ASSESSMENT METHODS IN DECISION MAKING ON MEDICINES


OBJECTIVES



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, trainees 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

Quantitative benefit-risk assessment methods, modelling, decision making, effectiveness, graphical representation, continuous benefit/risk monitoring

 

MODULE PARTS



  1. Introduction to benefit-risk analysis methods
  2. Benefit/Risk assessment during life cycle of medicines
  3. Measures based on statistics/simulation
  4. Health outcomes models

 

TRAINER TEAM



Coordinator: Dr Rianne Van Den Ham (from Utrecht Universiteit)

Expert(s): Prof Olaf Klungel, Dr Jet Van Der Zijden, Prof Toine Pieters, Dr Susanne Vijverberg, Yasmina Noorsyahdy Alif (from Utrecht Universiteit), Dr George Quartey (from F. Hoffmann-La Roche Ltd).

Intermediate level
75 h workload over 3 months (3 ECTS credits)
Key dates
Course calendar
Certificate award
or included in Master Year 2 or PhD programme
English language
Online based learning
Student: 1,500 €
Professional: 3,000 €
  Savings could be offered under eligibility conditions.

APPLY NOW

Applications open until December 08th, 2017

Or include this module in your training curriculum choices...

Master Year 2 PhD



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