Pharmacovigilance

 

PharmaCqARE set up Pharmacovigilance Systems tailored for the structures or for the countries, to allow the surveillance of the approved products, to prevent any risks of adverse drug reactions resulting from their use, and implements data collection, recording and evaluation processes.

PharmaCqARE follows up any local identified signals up to product information update and makes proposal of product information update in case of confirmed signals.

PharmaCqARE prepares or reviews any reports including PSUR (Periodic Safety Update Report), PBRER (Periodic Benefit Risk Evaluation Report), the DSUR (Development Safety Update Report) and RMP (Risk Management Plan).