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Substantiation and quantification of risks    Back

Eu2P Course Type: Short courses (CPD) Start Date: January
Duration: Part time - 6 Months Fees/total cost: EUR 5,000.00



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:

  1. Introduction: from case based reasoning to population based reasoning, examples: Augmentin, H1N1 vaccination, Yellow fever vaccine
  2. Theory of causality: causality from different perspectives, validity & causal diagrams, plausibility & substantiation
  3. Designing a study: study designs, basic epidemiological measures, data sources, workflow to quantify risks, case and exposure identification, codes of conduct, writing a protocol
  4. Data analysis: SAS, raw data to metrics, elementary and advanced analysis, controlling confounding, Bayesian methods, sensitivity analysis, meta-analysis
  5. Communication of results: communication with academia, regulators, pharmaceutical industry, writing a pharmacoepidemiological paper

Short courses (CPD) - Part time

Start date:
6 Months
Teaching method:
Distance Learning
Standard applicant fee:
EUR 5,000.00
Additional Information:
Application fee for students: EUR 2,500.00
Tuition fees

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Course Provider Details

Course contact information

Eu2P Central office

Recognised by

University accredited:
Short courses (CPD): 6 ECTS credits
Last update: 19/04/2017