Course Overview

> The aim of this course is:

- To enable participants (specialists) to develop an understanding of
the requirements of the Pharmaceutical Industry’s operational
aspects of pharmacovigilance as it relates to the preparation and
assessment of documents legally required by regulatory bodies.

- Focus will be on the adverse event reporting process within
Industry, placed within the context of regulatory requirements and
best practice.

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 cours consists of the following parts:

- Case reporting
- Periodic reporting
- Product Labelling and Risk Management Plans
- Contractual arrangements

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