Pharmacovigilance

Pharmacovigilance is the activity whose objectives are identification, quantification, assessment and prevention of the associated risks to the use of drugs once marketed, with the following aims:

• Earlier detection of adverse drug reactions and unknown interactions up to now.
• Establishing the frequencies increase in known adverse drug reactions
• Identification and minimization of risk factors and possible underlying mechanisms of the adverse reactions.
• Estimation of quantitiative aspects of the Benefit/risk balance and difussion of the necessary information in order to improve the regulation and prescription of drugs.

GP-Pharm, as marketing authorization holder laboratory is obligated to fulfill the current legislation regarding Pharmacovigilance issues: for this topic the company tools are:

• Detection, Management and follow up of the adverse reactions received through patients, caregivers, societies and health professionals (physicians, pharmacists,ect)
• Electronic transmission to the EMEA of the expeditive adverse reactions.
• Periodic Safety Update Reports generating.
• Risk Management Plan generating