Course Overview

> The aim of this course is:

- Definition of adverse drug reactions - type of ADRs.
- Detection and recognition of adverse events in clinical trials.
- Adverse event coding principles and differences.
- Spontaneous reporting databases.
- Principles of signal detection on electronic health care databases.
- Risk management plans.

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

> This course consists of the following parts:

- Introduction to statistics and probability.
- Estimates.
- Statistical testing.
- Introduction to multivariable linear regression.

Course type

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

Online Course Requirement

Instructor

Other information

- Professionals: 3,000€/year.
- Students: 1,500€/year.
- No additional costs and no mobility required.

Duration: 12 weeks

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

Site for Inquiry