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What will be remembered for the largest Russian GMP conference?

On September 30 - October 1, the most anticipated and significant event for specialists in the field of good practices, the V All-Russian GMP Conference with international participation, took place in the online format. 25 foreign regulators, members of the EEC and all EAEU countries, the Ministry of Industry and Trade of Russia, the Ministry of Health of Russia, Roszdravnadzor, NCESMP, GILS and NP, representatives of the OECD, the EU Delegation to Russia - all regions of the continent except Australia followed and took part in the event for 2 days , who became an integrator of GxP practices. 15 Russian trade missions held an online meeting with Russian pharmaceutical manufacturers. 2 award ceremonies and a number of other significant figures made it possible to achieve the online format of the event. More than 8,000 people watched the live broadcast of the conference in 2 days.

There is always close attention to the GMP conference, it is expected and included in the schedule for the next year immediately after the end of the event. This is one of the most visited events, which has always been evidenced by the stable growth of participants, which has doubled this year! As the First Deputy Minister of Industry and Trade of the Russian Federation Sergey Tsyb noted, the GMP conference is a landmark event for the pharmaceutical community, which makes it possible to develop new incentives and proposals to support the manufacturing sector in Russia, in terms of providing citizens with affordable medical products, and in the current conditions and allows for a more cohesive solution to issues arising in the fight against COVID-19.

Another important aspect of the GMP conference is the coverage of all GxP practices from the drug development stage to delivery to the end consumer. “After 5 years, along with the development and improvement of legislation and production technologies, the conference has turned into a discussion platform where they began to discuss not only good production practices, but also all practices that exist and can be talked about. The development and filling of the business program of the event by GxP-practitioners proceeded as the initiator of the GMP conference - FBU SILS and NP - of the Ministry of Industry and Trade of Russia was mastered and acquired additional competencies, - noted the Deputy Head of the Russian State GMP Inspectorate, Director of the Institute Vladislav Shestakov. - So, within the framework of the accreditation system, this year we have confirmed competencies in the field of GDP. The staff of SILS and NP employs 7 inspectors with GLP inspection competencies, which is confirmed by certificates and certificates of advanced training. Sharing experience with colleagues from MHRA and other significant international agencies in the field of GLP, we decided to introduce the best GLP cases to the entire Russian pharmaceutical industry. "

Fulfilling the tasks of the state contract with the Ministry of Industry and Trade of Russia, "SILS and NP" monitors the implementation of the state program of the Russian Federation "Development of the pharmaceutical and medical industry." This allows the analysts of the Institute to learn from the source about the problems of national producers. In particular, this is the dependence on imports of APIs and intermediates, which has exacerbated under the influence of the pandemic; dependence on pharmacopoeial reference materials of foreign pharmacopoeias and reference materials of private foreign manufacturers. As a result, in February 2020, SILS & NP acquired a subsidiary - NCSO (National Center for Reference Materials), and the topic of reference materials was included in the GMP conference program. “Our standard samples of the composition of ibuprofen (GSO 11559-2020), the composition of fluconazole (GSO 11569-2020), the composition of azithromycin (GSO 11570-2020) have been successfully tested at the Ural Research Institute of Metrology - a branch of VNIIM im. DI. Mendeleev. Agreements have been reached with this research institute on the certification of 7 more APS names (Acyclovir, Omeprazole, Captopril, Enalapril, Clopidogrel, Bisprolol, Propranolol). There are orders from Russian manufacturers of APIs as well,” noted Vladislav Shestakov.

For the second year in a row at the GMP conference site, heated discussions about the single EAEU market are being held, as well as industry business missions for national pharmaceutical companies, which allow them to receive answers and practical advice on bringing products to the markets of Latin America, the European Union, the African continent and the South -East Asia. Integration is a complex process that requires meeting certain deadlines. Large-scale work is being carried out in the direction of changes in legislation in order to bring it in line with the requirements of the EAEU. In particular, as noted by Alexey Alekhin, Director of the Department for Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, Resolution of the Government of the Russian Federation dated September 5, 2020 No. 1361 provides for the development and adoption of a number of regulatory documents of the Ministry of Industry and Trade of Russia. An important innovation is the granting of the Ministry of Industry and Trade of Russia the status of an authorized organization to implement the decision of the EEC Council (Resolution of the Government of the Russian Federation of September 15, 2020 No. 1446). "In accordance with this status, the Administrative Regulations have been developed for the provision of state services for the issuance of certificates of conformity of drug manufacturers to the requirements of the EAEU Good Manufacturing Practice Rules," the representative of the Ministry of Industry and Trade of Russia emphasized. This Resolution enables the industry to submit applications for inspection for compliance with the EAEU GMP in the Russian Federation.

An integral part of the GMP conference is a master class on good manufacturing practices. This year, the master class became the first platform in Russia where regulators from Russia, Azerbaijan, India, Great Britain, Spain, Croatia, Hungary, Bosnia and Herzegovina, Saudi Arabia, South Africa and Korea shared their experience in conducting remote inspections and gave practical advice to pharmaceutical companies to prepare for this process. As part of the master class, a virtual inspection of the production site in the format of a video tour took place. Of course, as the inspectorates of all countries note, the transition to remote inspections is a forced measure, but some experience from it can be transferred to the post-covid practice of inspecting manufacturers.

The popularity of the GMP conference over all 5 years is also due to thematic sessions on modern production technologies and the analysis of current guidelines and regulations governing the proper production of medicines in the EAEU, EU, PIC / S member countries.

The most important thing that a GMP conference gives is a level of professional trust between regulators from different countries and between regulators and drug manufacturers. The latter have been actively supporting the event for all 5 years. And they don't just support:

•  one of the leading international healthcare companies - MSD - shares its experience in localization and technology transfer of its socially significant drugs to Russian factories;

• Gedeon Richter provides its production sites in Hungary to GMP inspectorates of the EAEU member states for conducting joint training inspections;

• Roche, on the basis of the first online inspection carried out at their Swiss plant, demonstrated at the V GMP Conference how such events are held in real time;

• Tatiana Vyazmina, a regular participant of all GMP conferences, quality director of R-Pharm Group of Companies, presents practical reviews and recommendations every year to make improvements in the production of medicines, to bring the work of authorized persons at the enterprise in line with current requirements;

• Olga Maklakova, Quality Director of AKRIKHIN, and Stefan Rönninger, Director of Quality and External Relations of Amgen (Switzerland), generously share their practical experience in successfully passing GMP inspections.

2 days of online conference, perhaps, turned out to be even more intense than the traditional forms of the event. But the good thing about online is that at the end of the conference, you can access the recording and study the most important points from the point of view of pharmaceutical production.

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