FSI «SID & GP»
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ISPE Eurasian Economic Union Affiliate turns two. Contribution by the FSI “SID & GP” to the progress of the domestic pharmaceutical industry

The spring 2022 marks two years since the Eurasian Economic Union Affiliate of the ISPE  (International Society for Pharmaceutical Engineering) started its work. The history of the Eurasian affiliate of the ISPE commenced as early as the  year 2017, whereas the ideas to establish a local branch of the ISPE in Russia had been being voiced for 12 years.

 

 
The development and formation of the local ISPE branch is closely associated with the FSI “State Institute of Drugs and Good Practices”, Russian Ministry of Industry and Trade. The management and experts of the Institute extended their comprehensive support in working with the industry during the whole time of preparation for recognition and launching of the Eurasian branch of the Society. Russia’s first ISPE members were the professionals of the pharmaceutical industry who knew the importance of the ISPE knowledge base for the improvement of their own professional capability as well as that of their companies, with the majority of Russian members being the employees of the FSI “SID & GP”. Nowadays, the Institute takes an active part in the work not only of the ISPE Eurasian affiliate, but also of the global expert society itself.

Since 2005, the ideas of setting up a local ISPE branch were repeatedly expressed in Russian professional pharmaceutical community. In 2016, an action group of pharmaceutical professionals including Tatiana Vyazmina, Alla Mikhailova, Zdenek Pavelek, Tatiana Novikova, and Dmitry Voloshin, approached the FSI “SID & GP” with a request to facilitate the establishment of the ISPE affiliate in Russia. In April 2017, a group of representatives of the Russian pharmaceutical community led by Vladislav Shestakov, Director, FSI “SID & GP”, participated in the annual European ISPE Conference in Barcelona (Spain).

After holding fruitful talks with the ISPE leadership at the conference in Spain, Vladislav Shestakov, Director, FSI “SID & GP”, proposed expanding the ISPE branches from Russian to the Eurasian one. In July of that year, the delegation of the representatives of the pharmaceutical sector with the participation of the FSI “SID & GP” visited the ISPE headquarters in the USA. Since then, the formation and development of the Eurasian affiliate of the ISPE gained a new momentum, partly owing to the competent support of the FSI “SID & GP”.

Vladimir Orlov and Igor Falkovsky, the officials of the FSI “SID & GP”, were actively involved in the ISPE conferences over a period of several years: presentations by Russian experts were made at the round tables held as part of the ISPE conferences in San Diego in 2017, Rome in 2018, Dublin 2019, as well as on the online conference in 2020.

In the years 2017-2018, the pre-accession of the Eurasian affiliate to the global ISPE was handled by Alexander Sharonov and Rimma Abramovich successively. In 2019, the action group of experts unanimously elected Vladimir Orlov as the head and Oksana Pryanichnikova as the deputy head of the Eurasian affiliate of the ISPE.

In quite a short time, the Eurasian affiliate fulfilled a number of mandatory technical conditions, proved a high interest of the Eurasian Economic Union experts for the foundation of a local affiliate of the ISPE, and, in March 2020, obtained the official status of the ISPE Eurasian affiliate.

“The ISPE Eurasian affiliate, opened two years ago, became one of of the prominent platforms for integration of the EAEU member states into the global expert society, as well as for harmonisation with the international requirements to the manufacture of pharmaceutical products within the framework of the Eurasian Economic Union,” Vladislav Shestakov, Director, FSI “SID & GP”, noted. “Now that the domestic pharmaceutical industry is constrained to work in the stress conditions, the vast experience accumulated by the industry and the support of the government and industry associations make it possible to find high-performance solutions and new avenues for development in the event of a crisis. I am sure that the competences and level of expertise our professionals have will give the opportunity for building the pharmaceutical engineering system, design and operation of drug manufacturing in Russia that would comply with the internationally accepted standards.”

The mission of the ISPE Eurasian affiliate, as seen by its leadership, is implementation of the project cooperation with the global ISPE community as well as localisation of the advanced knowledge through conducting its own activities and engaging in industry events with support of home and international speakers. In particular, the ISPE Eurasian Affiliate Annual Conference became one of the notable events of the pharmaceutical industry over the last 2 years. Furthermore, the recent release of the Russian version of the ISPE guidelines on “Risk-Based Manufacture of Pharmaceutical Products”, the translation of which was prepared by experts of the industry – ISPE members from Russia and the EAEU, attracted a lot of attention of the pharmaceutical community.

In December 2021, the ISPE Eurasian affiliate submitted the draft guide on “Data Integrity and Computerised System Validation” to the EEC Council for its subsequent use as the recommendation for the drug manufacturing of the Eurasian Economic Union member states. The guidelines elaborated by the international team were widely discussed with the Russian pharma professionals, received a high assessment from the Russian Ministry of Industry and Trade, and are currently under consideration of the EEC Council.

“The ISPE Eurasian affiliate acts as a coordinating body and implements joint projects with educational institutions, such as Eurasian Academy of Good Practices and St. Petersburg State Chemical and Pharmaceutical University,” Oksana Pryanichnikova, Deputy Director of the ISPE Eurasian affiliate, marked. “The ISPE Eurasian affiliate was strengthened by new members of the Board of Directors last year, and we presume, with support of the active professionals of the industry, to succeed in arranging the work of the local technical committees similarly to the Special Interest Groups and Community of practice ISPE, as well as to continue our efforts on translation of the crucial ISPE guidelines for the benefits of the industry. “