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FGBU "VGNKI" TOOK PART IN CONFERENCE "MODERN APPROACHES TO THE EXAMINATION OF MEDICINES REPEC 2018"
19 November 2018 in Moscow was held a scientific-practical conference "Modern approaches to the examination of medicines RePEc 2018". The event was attended by employees of the Rosselkhoznadzor subordinate fgbi "all-Russian state Center for quality and standardization medicines for animals and feed" (fgbi "VGNKI"): Deputy Director of the institution Alexander Komarov and the head of Service of monitoring of efficiency and safety, and standardization of medicines for veterinary use and of feed additives Vasilina gritsyuk.
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Conference "Reglet 2018" held for the fourth time and is the only event in the Russian medical and pharmaceutical market, fully dedicated to the topic of registration of medicinal products in the common customs space of the Eurasian economic Union.

The event began with a welcome speech of Deputy Director of Department of state regulation of drug circulation, Russian Ministry of health Karen Sakanyan. During the conference, presentations were made by the Head of the Federal service for supervision in the sphere of health Michael Murashko and experts of the Ministry of health of the Russian Federation: Deputy head of Department of medicines assessment No. 4 TSEK GLS fsbi ntsesmp Ministry of health of Russia Galina Engalycheva and the management expertise of drugs No. 1 and No. 2.

The conference participants discussed the requirements for the results of pharmacokinetic studies, in particular the requirements for design validation and analytical reports. The speakers talked about the requirements for the content of these reports and about typical mistakes that experts identify in such reports during the examination.

Some of the presentations were devoted to the regulatory requirements of the Russian Federation and the Eurasian economic Union in terms of comparative test of dissolution kinetics (STCR). Highlighted the features of "biowaiver" used in the context of registration of medicines in the EEU and especially the assessment of equivalence of drugs, comparing in vitro.



Translated by service "Yandex.Translation"
Источники: Agro2b
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