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Overview

Signal Management is a critical process of Pharmacovigilance required by EU Good Pharmacovigilance Practice. It is the scientific component that underpins Pharmacovigilance, and the very reason why Pharmacovigilance was created in the first place.

The entire course has been updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX - Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII.

Time has been set aside for exercises, questions and discussions.

The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions. Data mining techniques for large volume ADR data analysis and relevant EMA guidelines will also be a discussed, as well as a future outlook.

Contact us

DIA Europe

Kuechengasse 16

4051 Basel

Switzerland

 

Tel: +41 61 225 51 51

Fax:  +41 61 225 51 52

E-mail: diaeurope@diaeurope.org