A system for monitoring medicine safety, aimed at detecting, assessing and preventing adverse reactions and other risks associated with the use of medicines.
Pharmasyntez Group continuously monitors the safety profile of the medicines it manufactures in accordance with international standards and regulatory requirements.
CULTURE
Patient safety and product quality are priorities for Pharmasyntez Group throughout the life cycle of its medicines. Pharmasyntez Group collects, analyses and evaluates adverse reaction data in accordance with international pharmacovigilance standards, the legislation of the Russian Federation and the requirements of Eurasian Economic Union (EAEU) regulatory authorities.
Pharmasyntez Group's pharmacovigilance system operates in accordance with GVP (Good Pharmacovigilance Practices), the requirements of EAEU regulatory authorities and international practices for ensuring medicine safety.
We coordinate marketing authorisation, validation, pharmacovigilance and quality control processes in accordance with international standards and regulatory requirements.
Continuous quality control and monitoring of GMP/GxP compliance at all Group manufacturing sites.
A culture of quality
Continuous monitoring of medicine safety to identify potential risks promptly.
Processing and assessment of information on adverse reactions and other cases associated with the use of medicines.
Analysis of medicine efficacy and safety to confirm a positive benefit–risk balance.
Development of measures to prevent and reduce risks associated with the use of medicines.
Providing up-to-date information on the safe and effective use of medicines.
CONTACT US
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