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


Eu2P Certificate: 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, 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

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 Jet Van Der Zijden (from Universiteit Utrecht)

Expert(s): Prof Olaf Klungel, Prof Toine Pieters, Prof Marieke De Bruin, Olivia Lewis (from Universiteit Utrecht).

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.

Applications currently closed

Application to this training will be available
from April 08th, 2024 to December 08th, 2024.
Thanks for applying during this period.

Contact the Eu2P Central Office

Applications will open on April 08th, 2024. Please contact the Eu2P Central Office for information.

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

Master Year 2 PhD



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