Results of II All-Russian GMP Conference
In Gelendzhik the II All-Russian GMP Conference draws conclusions; this year the Conference gathered 800 participants from 155 companies, more than 80 experts-speakers from different countries: the USA, Brazil, Spain, Croatia, Syria, Switzerland, Kazakhstan, Belarus. The Conference was organized by the Ministry of Industry and Trade of the Russian Federation and the Federal State Institution «State Institute of Drugs and Good Practices» of the Minpromtorg of Russia. The Conference has been held with the support of the Krasnodar Region Government. «Pharmstandart» has become the General Partner of the Conference; the event was also supported by the company «Gedeon Richter», which has become the Official Partner of the Conference. The Interfax news agency acted as the Federal Information Partner, and «Pharmatsevticheskiy Vestnik» acted as the General Partner.
«We frequently repeat that quality is not related to geography, an economic factor or a political link, – said Vladislav Shestakov, Director of FSI «SID & GP», – during the GMP Conference, in a dialogue on quality, potential, pharmacy development by leading market experts, these words have been confirmed many times».
On the first day, the grand opening of the Conference took place. It included the welcome words of the honorary event participants, the arrival of the Syrian delegation, who presented state awards to the Russian Inspectorate’ representatives, having inspected the Syrian pharmaceutical plants, and signing a number of significant partner agreements. Plenary sessions and panel discussions of the 1st Day: «Issues of industry regulation on the example of pharmaceutical production localization. Factors of development and regulatory obstacles», «EAEU countries integration into the international pharmaceutical system. PIC/S entry issues: main challenges, expected results», «GMP: inspection. EAEU GMP certificates mutual recognition mechanisms and support measures», «GMP: Next generation factories. GEP global trends». «For the Krasnodar Region, holding of the Conference has significant importance, – commented Deputy Head of the Krasnodar Region Administration Governor Sergey Altukhov. Over the last two years, Kuban doctors have conducted 26 high-tech operations. Each of them required quality pharmaceutical support. It is very important for us that the components, that serve all these operations and medical facilities, are also produced locally, so that medicines of better quality and which are more affordable are used».
The 2nd Conference Day opened with the presentation of a book written by V. Shestakov and Yu. Podpruzhnikov «What is good and what is bad in pharmaceutical production», which was introduced to the vast professional audience for the first time and kindled interest of the GMP-Conference’ participants. Moreover, at the 2nd Day opening, the winner of the I All-Russian Inter-University GxP-Summit with international participation «Choice of the best. Time forward», a student of the Russian National Medical Research University named after N.I. Pirogov, Armen Mezhlumyan gave a presentation.
Further, the 2nd Conference Day continued with plenary sessions, which were devoted to international regulatory practices, new approaches and current decisions in the area of pharmacovigilance. At the discussion site the relevant for industry topic on medicines labeling has been mentioned. Furthermore, a dialogue with the delegation from the Syrian Arab Republic led by the Deputy Minister of Health, Dr. Habbib Abboud, who highlighted the importance of strategic partnership with Russia, continued.
Within the 3rd Day, three parallel sessions were held for the heads of pharmaceutical companies, HR managers and responsible personnel. Unlike the previous days, the participants of the conference were able to actively participate in practical seminars and business workshops. In general, the participants of the conference noted the high level of the organization of the event, the actual theme and the professional composition of the speakers. In contrast to the previous days, Conference participants were able to actively participate in practical seminars and business cases. On the whole, Conference participants noted the high level of the event organization, the up-to-date theme and the professional composition of speakers’ pool. «GMP is philosophy, culture of production that allows us to create responsibility in order to grow into super-quality, – Sergei Tsyb, Deputy Minister of Industry and Trade, – We succeeded in shaping the correct sectoral thinking in this area».
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- 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