Course Overview

> The aim of this course is to:

- Understand how data on adverse drug events derived from analysis
of individual patients can lead to inferences regarding populations -
Know the various study designs in pharmacoepidemiology and to
determine which study design is appropriate to address specific safety
issues  - Be familiar with basic statistical concepts and techniques
as applied to pharmacoepidemiology - Understand and assist in
pharmacoepidemiological studies using large healthcare databases -
Understand the process of risk communication from the point of view of
different stakeholders

Learning Achievement

Competence

Course prerequisites

- Post-graduated leve in Health or Life Sciences.
- Language prerequisites: Non-native English speakers must provide a
certificate proving a minimum of English B2 level (cf. Europass
[http://europass.cedefop.europa.eu/]).
- Computer and internet requirement.

Grading Philosophy

- Assessment is a mix of continuous assessment.
- Final assessment takes place by videoconference.

Course schedule

1) Introduction: from case based reasoning to population based
reasoning
2) Designing a study: study designs, basic epidemiological measures,
data sources, workflow to quantify risks, case and exposure
identification, codes of conduct, writing a protocol

3) Designing a study II: Causality from different perspectives, Causal
diagrams, and Building a Statistical Analysis Plan

4) Raw Data to Metrics: Elementary and advanced analysis methods with
an introduction to data analysis in R

5) Communication of results: communication with academia, regulators,
pharmaceutical industry, writing a pharmacoepidemiological paper

Course type

Recorded and live lectures, readings, home assignments, on-line quizzes, forums, wikis, live seminars.

Online Course Requirement

Instructor

Other information

- Professionals: 5,000€/year.
- Students: 2,500€/year.

Duration: 24 weeks

Language of instruction: English
Mode of delivery: E-learning

Site for Inquiry