Round table VGNKI was dedicated to the Russian system of quality control of medicinal products for animals. At the event specialists of the Center presented four reports on the main stages and directions of operation of the system.
Leading researcher of the Department of examination and standardization of medicines for veterinary use and of feed additives of the fgbi "VGNKI" Pauline Lobova told about the Russian and international standards of preclinical studies of medicines for animals. Also Pauline Lobov briefed the visitors of the round table with the main areas of work and objectives of the Department of preclinical studies, fgbi "VGNKI".
Vasilina gritsyuk, the chief of Service of monitoring of efficiency and safety, and standardization of medicines for veterinary use and of feed additives of the fgbi "VGNKI", presented a presentation about the legal regulations and changes to them adopted in 2018 in relation to medicines for veterinary use in Russia. Special attention specialist noted the Order of the Ministry of agriculture of Russia No. 101 of 06.03.2018 "On approval of rules of conducting pre-clinical studies of medicinal products for veterinary use, clinical trial of a medicinal product for veterinary use bioequivalence study of a medicinal product for veterinary use". This document was also one of the main themes of the questions of the visitors of the round table.
The presentation of the Deputy head of the certification Body VGNKI Maria Bogdanova was dedicated to the certification of medicinal products for animals: design requirements legal documentation for the products, the responsibilities of the certification Body VGNKI on inspection control and other aspects.
Head of the Department of inspection of production conformity to requirements of good manufacturing practice VGNKI Daniel Rudnev made recommendations to the manufacturers of medicines for animals in preparation for inspection, and also presented the results of inspection of Russian and foreign manufacturers for 2018.
Round table of the fgbi "VGNKI" was attended by over 60 persons: authorised persons of manufacturers of medicines for veterinary use, representatives of research centers and journalists. At the end of the event, experts VGNKI answered numerous questions.
Translated by service "Yandex.Translation"