Course Overview

> The aim of this course is:

- To enable trainees to develop an understanding of European, USA and
major local and worldwide regulations and guidelines concerning
pharmacovigilance.

- Emphasis will be placed on the problems of interpretation of
pharmacovigilance regulations both pre- and post-authorisation.

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.

Course schedule

> This course consists of the following parts:

- Pharmacovigilance regulations: concept.
- The working Pharmacovigilance regulations.
- Other related Pharmacovigilance regulations and guidelines.
- Non-European pharmacovigilance regulations.

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