The work of the 8th International Partnership Forum «Life Sciences Invest. Partnering Russia» in St. Petersburg
The 8th International Forum ‘Life Sciences Invest’ began with a press breakfast, hosted by Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation. In his speech, he made a special emphasis on the development of innovative technologies in the pharmaceutical industry, development of the domestic pharmaceutical industry to proceed into the foreign markets, as well as further comprehensive inter-sectoral interaction with the medical and therapeutic communities.
— One of our tasks is strengthening all areas of interaction with the medical and therapeutic communities. Today we pursue an ambitious goal to integrate the industry and engineering force in close cooperation with doctors, physicians, and healthcare stakeholders. Without integration and close cooperation, the pharmaceutical industry will not be able to develop.
Sergey Movchan, St. Petersburg Vice-Governor, took part in the press breakfast, officials from the Ministry of Healthcare of the Russian Federation, the Ministry of Economic Development of the Russian Federation, leaders of domestic pharmaceutical businesses, and Director of the State Institute of Drugs and Good Practices — Vladislav Shestakov.
In his speech, he underlined the importance of a unified and harmonized regulatory system:
— Everyone is after «effective, safe, and high-quality pharmaceuticals.» These words appear in many documents and programs. However, what are the criteria for efficacy, safety, and quality? Different regulatory systems perceive them differently. At the same time, the patient in any corner of the world has the right to expect that the drug meet all these criteria, regardless of where it is developed and manufactured. Our mission is to ensure control over the implementation of these principles.
The business program continued with the plenary session dedicated to Transition of the industry to global competition. Dmitry Chagin, Chairman of the Board of the Association of EAEU Pharmaceutical Manufacturers moderated the session. Sergey Tsyb – First Deputy Minister of Industry and Trade of the Russian Federation – opened the session. In his speech, he noted the continuation of the development strategy for innovative pharmaceutical production in the program Pharma-2030.
Vladislav Shestakov – Director of the State Institute of Drugs and Good Practices – took the floor in the framework of the session. In his speech, he expanded on development of the pharmaceutical industry in Russia, which is quite young, but already accumulated rich and unique experience. From 2016 through November 2018, 1.293 inspections of foreign pharmaceutical manufacturers were completed. For the past 2 years, the number of countries where production facilities were inspected by the Russian pharmaceutical inspectorate has increased from 40 to 68 worldwide. Vladislav Shestakov also touched upon the issues of transition to a common pharmaceutical circulation market within the Eurasian Economic Union, questions of harmonization and development of mutual trust of inspectorates.
— Our institute, together with the EAEU member states, is actively involved in shaping unified approaches and methods of inspections. This is done to design a standardized approach of inspections in compliance with the best international experience.
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)
- Russia will be able to join PIC/S and break into new pharmaceutical markets