FSI «SID & GP»
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FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies

Company Sandoz, a division of the Novartis Group, in conjunction with FSI “SID & GP” of the Russian Ministry of Industry and Trade held the first international forum on biotechnologies.

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The main topics of the forum were focused on discussing advanced experiences and best practices in the field of manufacturing, quality assurance and increasing the accessibility of biologicals for patients. The forum’s remote format made possible the participation of more than 70 specialists and experts of the Russian Ministry of Industry and Trade, the Russian Ministry of Health, Federal State Institution “State Institute of Drugs and Good Practices” of the Russian Ministry of Industry and Trade and the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Russian Ministry of Health, and also international biotechnology experts from companies Novartis and Sandoz.

Bioforum – a joint initiative of FSI “SID & GP” of the Russian Ministry of Industry and Trade and company Sandoz, is aimed at establishing an expert platform for an open dialogue and exchange of best practices in development, manufacturing, quality assurance and accessibility of biologicals for patients in the Russian Federation.

In his welcoming address to the Bioforum’s participants, Director of FSI “SID & GP” of the Russian Ministry of Industry and Trade Vladislav Shestakov emphasised the importance of an open dialogue between the regulators and industry for the purpose of development of the biotechnological sphere in Russia.

Vladislav Shestakov: “Biotechnological manufacturing does not stand still, companies are constantly offered new solutions in development and manufacture of drugs, aimed at improving the manufacturing process and assuring high quality of medicinal products. Speaking on behalf of the Russian GMP Inspectorate, we attach great significance to such form of collaboration between the regulator and industry, feedback from manufacturers, readiness to demonstrate their know-how in the field of biotechnology, developments and manufacturing of biosimilars. I am confident that this Bioforum will be of benefit for both the manufacturer and regulator. This is an excellent opportunity for sharing experiences and discussing wide-ranging issues in the field of biotechnology”.

On the first day of Bioforum discussions were held on the best practices and advanced experiences in the field of manufacturing of biologicals, including issues pertinent to regulation, quality assurance in manufacturing of pharmaceutical substances and finished dosage forms, as well as ensuring the accessibility of biological products for patients. The presenters were international experts, who head relevant divisions in the structure of Sandoz as well as representatives from a global manufacturing organization Novartis.

On the second day the participants of Bioforum were introduced to the novel solutions in the manufacturing of biologicals, having examined all the manufacturing stages of pharmaceutical substances and finished dosage forms on the example of a biological complex Shaftenau in Austria, which performs full manufacturing cycle of biologicals for Novartis Pharma and Sandoz companies.

“Despite the constraints due the difficult epidemic situation in the world, thanks to modern digital technologies, we were able to organize an effective platform for sharing experiences and discussing a whole range of issues in the sphere of biotechnology between Russian regulators and international experts, – underscored Manlio Florenzano, General Manager of Sandoz in Russia. – On behalf of Bioforum’s organisers, I thank all participants and Vladislav Shestakov personally for supporting this initiative and actively participating in the forum”.