In 2021, the event gathered a big audience: more than 80 speakers and experts, including 23 foreign ones, 487 in-person participants, and more than 2 thousand online attendees from 42 countries.
The VI All-Russian GMP Conference with international participation was organized by the Ministry of Industry and Trade of the Russian Federation in cooperation with the Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of Russia, and the Conference operator –
S-GROUP Corporate Communications.
GMP Conference is a unique platform distinguished both by its clearly focused topics and opportunity to hold a direct dialogue between regulators and manufacturers, complemented by global best practices.
The VI All-Russian GMP Conference opened with a plenary session under the motto “Strong Regulator – Strong Industry” moderated by Dmitry Galkin, Director of the Department of Development of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, and Vladislav Shestakov, Director of the Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of Russia (FSI «SID & GP»).
Today, global healthcare is facing new challenges, in which the authorities are required to come to quick and viable solutions and improve legal framework to meet interests of both the industry and healthcare consumers. Lessons learned during the COVID-19 pandemic have highlighted the role that accelerated development and registration, market launch and increase in production of urgently needed drugs can play in the shortest possible time under special conditions.
Dmitry Galkin emphasized that expanding product range calls for compliance with requirements that, in good industrial practice and in all other good practices, ensure quality, efficiency and safety, and the result of all actions, both in production and in treatment, must be focused on strengthening the healthcare system. He also underlined the importance of multi-level interaction:
“Amidst the increased pressure on the healthcare system, strong regulation allows pharmaceutical industry to maintain high standards and produce high-quality, safe and effective medicines. Indeed, there are no double standards in matters of quality. The motto of the plenary session and the entire conference is “Strong Regulator – Strong Industry”, which in the modern world is more relevant than ever,” Dmitry Galkin said.
Vladislav Shestakov noted that amid the fight against the new coronavirus infection, a lot of implemented projects have demonstrated the effective interaction of authorities, scientific community, and business. And such work has been carried out all over the world. Regulators in most countries are faced with the question of how to quickly change the system in order to help the entire healthcare work efficiently.
Representatives of regulatory authorities of the EAEU countries, Cuba, Algeria, Australia, Hungary, the Dominican Republic, Bangladesh, as well as European and African Unions, shared their pandemic strategies and steps taken to overcome the crisis in their territories. In particular, the reports concerned the system of state regulation of new drug circulation.
Summing up the series of speeches, moderators formed the general opinion that at this stage, there is no doubt about the need for a balanced, reasonable approach at all stages of drug circulation, and regulators should promote best practices to meet the needs of healthcare with high-quality and safe products.
At the end of the plenary session, important agreements were signed. FSI «SID & GP» of the Ministry of Industry and Trade of Russia, the Eurasian Academy of Good Practices and Nomix LTD signed a tripartite document, according to which the FSI «SID & GP» of the Ministry of Industry and Trade of Russia transfers to the Academy the rights to implement training programs using the “Virtual Plant 2.0” project, a virtual reality plant for the production of solid form drugs.
The second agreement on the development of reference materials for biotechnological drugs was concluded between the National Centre for Reference Materials and the Federal Research Centre “Fundamentals of Biotechnology” of the Russian Academy of Sciences – a leading scientific organization in the field of biotechnology. Standard samples of biotechnological drugs have not yet been produced in Russia, therefore this agreement is of particular importance for Russian pharmaceuticals.
On the sidelines of the Conference, other agreements were signed between the FSI «SID & GP» of the Ministry of Industry and Trade of Russia and the Roche company concerning the implementation of scientific and technical programs and projects to increase the availability of innovative medicines for Russian citizens, as well as between the Eurasian Academy of Good Practices and the company Binnopharm Group, aimed at meeting the needs of the industry in the development of new professional programs, including those using augmented and virtual reality.
The main focus of the business program of the Conference was regulatory changes associated with the transition of pharmaceutical market to uniform rules for drug circulation within the Eurasian Economic Union, the specifics of biological medicine production, the role of good pharmaceutical practices in regulating medicine life cycle, the evolution of the system of domestic pharmaceutical developments and full-cycle production.
Olesya Funtasheva, the leader of Good Manufacturing Practice at Roche, presented her business perspective on the transition to industry regulation in compliance with the EAEU rules. Among the main issues to be addressed in the nearest future, she named unification of procedures for conducting pharmaceutical inspections in terms of securing all stages of inspection in a single document at the EAEU level. It is also necessary to fill in timing gaps.
Today, for declarative inspections of production sites outside the framework of registration procedures, regulatory documents do not mention maximum period from the moment the regulator decides to conduct an audit until it is actually carried out. For inspections within registration procedures, this period used to be 180 calendar days, however, from January 2022, this rule ceases to be effective.
“Lack of clear deadlines can cause difficulties in providing permanent certificates of compliance with the rules of good manufacturing practices in the EAEU, and slow down the process of filing new drug applications. It is necessary to establish a maximum period from the moment an authorized body decides to conduct a pharmaceutical inspection to the actual inspection at the production site by analogy with the national inspection procedure in the Russian Federation,” – Olesya Funtasheva said.
Another industry opinion was expressed by Natalya Volovich, Deputy Director, Head of Registration Department of the Representative Office of Gedeon Richter OJSC (Hungary) in Moscow.
“The common EAEU market still exists only on paper. For practical implementation, we all need to clear up how to ensure the availability of drugs for patients in the volume and according to the indications they are used to. Depending on the EAEU country, one drug could initially have different indications or different statuses of dispensing from pharmacies (with or without prescription). We – manufacturers and regulators – now face a difficult task to harmonize the portfolio of drugs and keep their assortment”, Natalya Volovich noted.
Supported by Natsimbio, the General Partner of the VI All-Russian GMP Conference, a panel discussion “Modern Approaches to the Production of Biological Drugs in Compliance with the Requirements of Good Practices” was held.
Testing requires development, certification and maintenance of standard samples at an enterprise, while the quality control system, according to the session participants, requires updating. Another growth vector is drugs for new infections arising in the modern world.
“Emergence of new infections requires the development of new biological products in a short time frame, and promotes new approaches to technologies of production, control, automation of existing processes for making high-quality products meeting needs of modern civilization,” commented Alla Mikhailova, Quality Director at NPO Microgen, one of the leading manufacturers of biological products in Russia (Natsimbio holding of the Rostec State Corporation).
The third day of the Conference featured a master class on technology transfer. In the first part, participants were introduced to the existing regulatory requirements of both Russia and other countries, as well as the practical experience of transfer from the point of view of GMP inspection. The second part was a simulation game of one of the stages of routine inspection of drug production. It is worth noting that master class format, as in previous years, aroused great interest and brought together many participants and attendees.
Another initiative that has become traditional for the All-Russian GMP Conference is the rewarding of the best industry specialists who guarantee the quality of pharma products. In 2021, the leading technical directors of Russian pharmaceutical companies received awards for significant professional achievements. The winner was Mikhail Molotkov, Technical Director of R-Pharm, the second was Andrey Rykov, Chief Engineer of Pharmasyntez, the third was Alexander Krechun, Technical Director of Valenta Pharm, who also won the Industry Choice nomination.
Summing up the results of the Conference, Vladislav Shestkov, Director of FSI «SID & GP» of the Ministry of Industry and Trade of Russia, highly appreciated the interest and contribution of regulators and pharmaceutical industry both in Russia and other countries when discussing topical issues during sessions, master classes, and business meetings.
The partners of the VI All-Russian GMP Conference with international participation:
- General partner: Natsimbio holding of the Rostec State Corporation;
- Strategic partners: Roche, Gedeon Richter;
- Official partner: Amgen;
- Conference partners: Teva, MSD Pharmaceuticals, Novartis Group Russia, Novo Nordisk;
- Session partners: Petrovax Pharm, Abbott, PRO.MED.CS Praha a.s, Akrikhin, Association of Veterinary Pharmaceutical Manufacturers (AVPHARM);
- Special partners: PharmEco Group, Nanolek, Boehringer Ingelheim Russia, Pharmaceutical company “Bosnalijek”, Samson-Med, Binnopharm Group;
- Linguistic partner: Janus Life Sciences;
- Online exhibitor: Shimadzu;
- Partner of the Best Technical Director award ceremony: ERWEKA