Fundamentals of Quantitative Benefit-Risk Assessment Methods in Decision Making On Medicines

Practical Information

Commencing Date:
World Wide (Distance Learning)

Teaching Methodology:
Distance Learning
Credits :
Short courses (CPD): 3 ECTS credits

European Fees:
3000 EUR
Scholarship Possibilities:

Course Contact

Eu2P Office

+ (33) 5 57 57 92 57


Office Link


University Accreditation: Yes

PharmaTrain Centre


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. Topics covered: Introduction to benefit-risk analysis methods Benefit/Risk assessment during life cycle of medicines Measures based on statistics/simulation Health outcomes models

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered