Coordinateur : Xavier Kurz - European Medicines Agency Parmacovigilance and Risk Management London, United Kingdom

Responsable LIMICS : JAULENT Marie-Christine

Autres membres LIMICS : Cédric Bousquet

Résumé :

The goal of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. This will be achieved by developing a set of innovative tools and methods that will enhance the early detection and assessment of adverse drug reactions from different data sources, and enable the integration and presentation of data on benefits and risks.

A methodological framework for pharmacoepidemiological studies will be developed and tested to enable data mining, signal detection and evaluation in various types of datasets, including data of spontaneous reports, registries and other electronic databases.

Partenaires

Academics, regulators, SMEs - EFPIA companies