The pharmacovigilance is a system organized by holders
of registration certificates for medicinal products and authorized bodies of
the Member States of the Eurasian Economic Union to perform the tasks and
duties of pharmacovigilance, intended to control safety of medicinal products,
timely implementation of all changes in the assessment of the benefit-risk
ratio of medicinal products, development and implementation of measures to
ensure the use of medicinal products when the benefit exceeds the risk.
Pharmacovigilance is one of the most important functions of the healthcare system due to the fact that it aims to quickly identify and respond to potential safety hazards connected with the use of medicinal products.All employees of a pharmaceutical company should be involved in the pharmacovigilance process, and the effectiveness of the pharmacovigilance system directly depends on the collective efforts of many employees, coordinated by the Authorized Person for Pharmacovigilance. The result of effective work of the pharmacovigilance system is reduction of risks from use of medicinal products and establishment of conditions for the best medical care for individual patients and increase the safety of the population on the whole.
To build an effective pharmacovigilance system at any stage, Statandocs experts:
- evaluate existing processes,
- develop and update standard operating procedures,
- develop master file,
- conduct employee training,
- monitor literature,
- provide services of an authorized person for pharmacovigilance, etc.