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Well-coordinated work and close cross-sectoral cooperation as a growth engine for domestic pharmaceutical sector

Vladislav Shestakov, Director of the FSI “SID & GP” of the Russian Ministry of Industry and Trade, took part in the “RegLek 2022” scientific and practical conference.



On November 16, Vladislav Shestakov, Director of the FSI “SID & GP” of the Russian Ministry of Industry and Trade, spoke at the “RegLek 2022” scientific and practical conference on Regulatory Practice and Registration of Medicines, taking place on November 16-18 at the Analytical Centre under the Government of the Russian Federation.

In his presentation on the development of expert activities in GMP inspections under the current geopolitical conditions, Vladislav Shestakov outlined the impact the recent events, such as COVID-19 pandemic and economic sactions against our country, have had on the operation of the Russian GMP Inspectorate, too. Due to the impossibility of conducting on-site inspections in 2020 and the risk of drug shortage, the experts of the FSI “SID & GP” proposed conducting remote inspections. Such a technological breakthrough made it possible not to stop inspections of foreign production sites.

Now, on-site inspections of manufacturing sites are gradually being resumed.

“At the moment, notwithstanding some ligistics challenges, on-site inspections are getting resumed. This points to the fact that health and safety of the country’s citizens are above geopolitical and economic issues”, highlighted the Deputy Head of the Russian GMP Inspectorate Vladislav Shestakov.

He further marked that inspectors constantly upgrade their expertise, so that it is obligatory for each inspector to undertake an ultimate course of study in their major, while training at the best educational platforms for good practices is also conducted recurrently.

One of the professional growth tools is the VR factory developed by the professionals of the FSI “SID & GP”. Its platform applies AR and VR technologies and has entirely realistic visualiosation of the production facilities and pharmaceutical production processes. The simulator enables training inspectors providing an opportunity to go through all the phases of the real inspection at a solid dosage forms pharmaceutical production facility and presenting the inspection process in an authentic way. The solid dosage forms production facility project was implemented in 2021, and currently the “Biotechnological Production” is under development, which would become the second part of a large-scale Virtual Pharmaceutical Manufacturing Unit.

He noted that “Virtual Factory 2.0” is one of the first steps to create digital twins. The programme for their development was initiated by the Ministry of Industry and Trade of the Russian Federation.

At the end of his speech, Vladislav Shestakov stressed the importance of expanding the boundaries of interaction and forming new centers for expert decision-making.

“Challenges, such as the COVID-19 pandemic, have shown the significance of and need for joint coordinated actions of relevant federal agencies of executive authority with the industry, which were the key to solving the problem of drug provision in tough times in healthcare. In the current geopolitical situation, well-coordinated work and close inter-sectoral cooperation is the engine that facilitated the growth of the domestic pharmaceutical industry and generally impacts the national drug safety assurance,” Vladislav Shestakov said in his address. “Today, more than ever, it is important to expand the boundaries of interaction again and form new centers for expert decision-making. The development and strengthening of ties within established unions, such as the EAEU, SCO, BRICS, seems to us to be one of the vectors of movement in the current conditions.”