Pre-New Year address of V. Shestakov
On behalf of the State GMP Inspectorate and Federal State Institution «State Institute of Drugs and Good Practices» of Minpromtorg of Russia I wholeheartedly congratulate you all on the coming New Year!
The outgoing year 2017 has become full and interesting with events, including for our Institute. First of all, we are proud to have fulfilled the planned indicators for the inspection of foreign medicines manufacturers. Our inspectors conducted more than 500 inspections in different parts of the world, including crisis spots, for which they were awarded the highest state awards of the Syrian Arab Republic.
Besides that, together with the Ministry of Industry and Trade of the Russian Federation, we have organized a number of serious events of high significance for the entire industry. For example, the All-Russian Inter-University GxP Summit “Choice of the best. Time forward”, aimed at increasing the prestige of profession in the pharmaceutical industry among talented young people, was held for the first time in Russia. Also, we successfully conducted the II All-Russian GMP-Conference in Gelendzhik, which gathered about eight hundred participants from different countries of the world.
Another significant event in 2017 is our joint application with the Minpromtorg of Russia for the Russian Inspectorate entry into the PIC/S (the Pharmaceutical Inspection Co-operation Scheme) under the procedure of pre-application. The membership in PIC/S will let to cooperate with inspectorates all around the world, share the accumulated experience and openly discuss on equal terms with foreign colleagues the issues of conducting inspections.
It is worth mentioning another important initiative that has been supported by the Minpromtorg of Russia and implemented this year: opening of the independent Eurasian ISPE Affiliate, whose goal is to access the pharmaceutical community of the EAEU countries to global trends and world expertise in the field of pharmaceutical engineering.
Undoubtedly, cooperation with specialized international organizations is a major focus, aimed at developing good practices and forming a professional value system at the sectoral level. Thanks to such activities, our industry is becoming more integrated into the world community, what allows developing, adapting and implementing the best international practices at the Russian market.
One such example is the labeling of medicines, under the auspices of which, following the world trends, the current year has passed for the Russian pharmaceutical industry and, undoubtedly, will pass the whole next year. According to our estimates, 2018 will become a truly living and active time for productive work and development of the industry.
Creation of a new program for the industry development Pharma-2030 will definitely set new vectors and industry trends that would be implemented in the future. Moreover, the next year will be marked by intercountry teamwork within the EAEU. In particular, a permanent working group of EAEU inspectorates will be founded. In addition, a lot of attention will be paid to the further transition of the Russian industry to GMP standards.
Labeling of medicines, digital medicine, intellectual property rights, regulatory framework improvement, alignment and harmonization within the EAEU framework, development of interagency cooperation, further transition to GMP standards and active implementation of other good practices are the key areas that will be emphasized in the coming year.
In its turn, our Institute, in addition to the immediate activities, is planning to continue active work on cooperation with other countries’ Inspectorates. The formation of confidence in the inspections conducted by the Russian Inspectorate on the world arena is the basis that contributes to the development of the Russian industry export potential.
Continuing issues of the next year, which our Institute does not leave without attention, are the shortage of qualified personnel and the necessity to develop a professional educational sectoral platform. Topical issues, related to the development of human resources and investments in human capital, will be also discussed at the main events traditionally supported by the Institute and Minpromtorg of Russia – the II All-Russia Inter-University GxP Summit with international participation “Choice of the best. Time forward” (July 3-5, Grozny) and III All-Russian GMP-Conference with international participation (August 27-29, Kazan).
From my part, I wish our colleagues and partners all the brightest and kindest the next year. Let your house be filled with happy laughter and positive emotions. Let dreams come true, and good luck never let you out of its embrace.
With coming 2018, dear friends!
- The inspection of the foreign pharmaceutical company registering its drug product in Kazakhstan was carried out by the Russian Inspectorate
- 157 license holders out of 189 manufacturing sites have received a GMP-certificate following the procedure of filing an application
- Giuseppe Fedegari: «The shortcut to training: working with people who already have the experience»
- FSI «SID & GP» is holding a training workshop with international participation for pharmaceutical inspectors
- On 07 February, a new solids manufacturing facility was launched by the «Obolenskoe» Pharmaceutical Enterprise