Substantiation and Quantification of Risks

Practical Information

Commencing Date:
World Wide (Distance Learning)

Teaching Methodology:
Distance Learning
Credits :
Short courses (CPD): 6 ECTS credits

European Fees:
5000 EUR
Scholarship Possibilities:

Course Contact

Eu2P Office

+ (33) 5 57 57 92 57


Fees Information

Office Link


University Accreditation: Yes

PharmaTrain Centre


Objectives: To enable students to design studies, write protocols To quantify and analyse safety signals or risks To understand the potential and limitations of post marketing hypothesis testing studies Topics covered: Introduction: from case based reasoning to population based reasoning, examples: Augmentin, H1N1 vaccination, Yellow fever vaccine Theory of causality: causality from different perspectives, validity & causal diagrams, plausibility & substantiation Designing a study: study designs, basic epidemiological measures, data sources, workflow to quantify risks, case and exposure identification, codes of conduct, writing a protocol Data analysis: SAS, raw data to metrics, elementary and advanced analysis, controlling confounding, Bayesian methods, sensitivity analysis, meta-analysis Communication of results: communication with academia, regulators, pharmaceutical industry, writing a pharmacoepidemiological paper


Quality - GMP, GCP, GLP

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