Pharmacovigilance
The etymological roots for the word “pharmacovigilance” are: Pharmakon (Greek for medicinal substance), and Vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on monitoring of safety of medicinal products: activities aimed at detecting, evaluating and preventing adverse drug reactions (ADR) or any other potential problems related to medicinal products.
The system of pharmacovigilance is one of the components of the quality management system (QMS), which operates in accordance with ISO 9001-2015 International Standard.
Marketing Authorizations should enable and ensure efficient operation of the system of pharmacovigilance within the organization in order to increase the responsibility of the organization for the quality and safety of medicinal products, as well as to take, if necessary, adequate measures on a timely manner aimed at improving the safety of medicinal products. For that an appropriately qualified person responsible for pharmacovigilance (hereinafter referred to as the “QPPV”) with the required qualifications should be appointed.
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The objectives of the system of pharmacovigilance are as follows:
Study
Following up the safety of marketed medicinal products put to clinical use in large populations.
Dissemination
Dissemination of data obtained in the course of monitoring through the specialized mass media.
Monitoring
Monitoring data received from the most recent, up-to-date Russian sources.
Risk Management
Risk management (identification and minimization of risks), development of measures to be taken in order to review (post-registration studies, registers, etc.) and minimize risks (information, training, restricted access programs), preparation of risk management plans.
Dealing with inquiries
Dealing with the inquiries of the regulatory authorities (including the approval of risk management plans, safety issues as a result of quality defects, customer complaints, correspondence with regard to the planned regulatory decisions).
Fraud
Detection of counterfeited and substandard medicinal products, etc. Identification of the use of medicinal products for unstudied and unapproved indications.
Off Label
Identifying the use of medicines for unstudied and unapproved indications (off label).
Abuse
Identification of abuse of medicinal products.
Errors
Detection of medical errors.
Impact
Identification of the impact of medicinal products on the quality of life.
GVP EAEU
Preparation of periodic reports on safety in the format of the EAEU GVP.
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We offer our services to the Russian and international pharmaceutical companies to conduct voluntary audits of the pharmacovigilance system, in accordance with the following requirements:
- Federal Law No. 61-FZ “On circulation of medicinal products” of 12.04.2010 (as amended and revised on 03.07.2016, effective of 01.01.2017, Article 64)
- Order of Roszdravnadzor No. 1071 “On approval of the Procedure for the implementation of pharmacovigilance” of 15.02.2017
- Rules of Good Pharmacovigilance Practice (GVP) adopted by Decision of the Council of the Eurasian Economic Commission No. 87 of 3 November 2016 (EAEU GVP)
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corp. 1, 14th floor, office. 14014