Building a pharmacovigilance system

Pharmacovigilance system is a system organized by the market authorization  holders of medicinal products and authorized bodies of in Russia, EAEU, CIS, EU to fulfill the tasks and responsibilities in pharmacovigilance and is designed to control the safety of medicinal products, to implement all changes in the evaluation of “benefit-risk” ratio of medicinal products in time, to develop and implement measures to ensure the use of medicinal products when the benefit exceeds the risk.

BUILDING A SYSTEM OF PHARMACOVIGILANCE AT ANY STAGE

DEVELOPMENT OF MASTER FILE

CREATION OF EFFECTIVE SOPs

X7 Research has been building pharmacovigilance systems since 2010. The key moments of our specialists’ work are a creation from scratch or assistance in the improvement of the existing pharmacovigilance system of the company.

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