For the past two years, we have been witnessing how important it is for countries to have their own developed biopharmaceutical industry and science. With global shortage of industrial capacity for vaccine production, many countries have become dependent on foreign manufacturers. In recent years, the Russian regulatory system has been improving, programmes are being implemented to support domestic biopharmaceutical production and high-tech technologies, which ultimately made it possible to effectively respond to the main challenge of the times and develop new vaccines against COVID-19.    

Our company was established by Rostec State Corporation, which focuses on security issues, including national health issues as a response to the public need to ensure independence in domestic production of biological products and, above all, vaccines. For more than five years, we have been managing Russian developers and manufacturers of immunobiological drugs assigned to the holding, during which time we have achieved significant success in specific segments − in particular, in the fill-finish production of influenza vaccines, as well as a number of live and specific vaccines. Today, their share in government vaccination programmes has reached 100%, and, no doubt, this is also the result of a synergy between business and the government. 

It is important to note that not a single successful project related to providing citizens with affordable and effective drugs is born all by itself, it always results from a dialogue between the expert community, business, legislation, and executive authorities, including at industry events. The International GMP Conference is one of the influential platforms focusing on the key problems and challenges of the pharmaceutical industry development. 

Our company has participated in the Conference for several years, and we give credit to the organisers for creating positive atmosphere, working out an informative agenda and raising the issues topical for the industry, thereby contributing to the implementation of key initiatives and projects in practice. 

We wish the guests and organisers of the Conference fruitful work. 


Andrey Zagorsky, General Director of Nacimbio 

A Welcome Address of N. Volovich to the Participants and Guests of the VI All-Russia GMP Conference


Gedeon Richter can freely claim the title of one of the oldest players in the Russian and international pharmaceutical market: this year we are celebrating the 120th anniversary of its foundation. Throughout the history of its existence, our company has experienced different periods, but the challenge the entire world faced in early 2020 cannot be compared with anything. Neither the world, nor we, nor the market will ever be the same again, and we need to learn to live with these changes, and not only to keep the efficiency of our business, but also to bring new solutions to the pharmaceutical industry, the need for which is now especially great.

For several successive years, we have been actively participating in the GMP conference and we can observe productive dialogues at event sites – even last year’s experience in the online format did not reduce the interest of participants. For our part, from year to year we strive for an international exchange of experience and involve our foreign colleagues in participation.

In the new reality, it is vitally important to contribute to complete development of the healthcare trend by combining the efforts of all parties: the state, business, doctors, patients. The search for new solutions and increasing research in the field of treating serious diseases, increasing the availability of therapy and medical care, production localization, compromise solutions in the field of medicines regulation and circulation – qualitative improvements in healthcare depend on all of us and on each of us individually.

I greet all colleagues who will visit the event for a constructive discussion and dialogue, who are not indifferent to people’s well-being and health – I wish all of us productive meetings, new ideas and right decisions!


Natalia Volovich
Deputy CEO, Head of the Registration Department,
Gedeon Richter (Hungary), Representative Office in Moscow

Greetings from Lars Nielsen, general manager, Roche-Moscow, JSC to the participants of the 4th All-Russian gmp conference

Dear Colleagues! High-quality, effective and safe medicines are an important element of a sustainable healthcare system.

Consumers expect that each series, each package of a medicine, whether it is produced in Russia or abroad, at a factory of originator or contract manufacturer, meets all applicable standards and requirements throughout its life cycle.

For a global company operating in more than 100 countries, like Roche, standardization and harmonization in the field of development, production and distribution ensures that the quality of products is maintained all the way to the consumer.

In this context, the selection of reliable partners is becoming a priority. Since 2008, we have been successfully cooperating to bring the production of our products to Russia, supporting the state strategy for the development of the pharmaceutical industry. At our partners’ facilities, various phases of production of 15 Roche medicines are carried out. They all indented for the treatment of diseases of high social significance, including cancer, infectious and autoimmune diseases.

Today we are opening a new chapter in partnership with the Russian companies and preparing to launch the process of localization of our two latest products for the treatment of hemophilia and multiple sclerosis, which have no analogues on the world market. This is a huge responsibility to patients, their families, healthcare providers, the public and the state.

Roche is pleased to be a strategic partner of the IV All-Russian GMP Conference and to contribute to the discussion of key issues in the development of the pharmaceutical health sector, such as improving the quality of products and providing patients with effective and safe innovative medicines.

I wish all the participants interesting and productive work.

Lars Nielsen
General Manager
Roсhe-Moscow, JSC

Welcome Address from Grigory Potapov, Chief Executive Officer, Pharmstandard JSC to Participants of the 4th All-Russia GMP Conference

Dear colleagues! For the fourth time, the All-Russian GMP Conference has gathered on its site scientists, opinion leaders, representatives of relevant ministries and departments, the pharmaceutical manufacturers and professional associations to discuss key issues and major trends in the pharmaceutical industry.

For the fourth time, the All-Russian GMP Conference has gathered on its site scientists, opinion leaders, representatives of relevant ministries and departments, the pharmaceutical manufacturers and professional associations to discuss key issues and major trends in the pharmaceutical industry.

Over the years of its operation, GMP Conference has become an authoritative international platform for various government science and business authorities together dialog during which specific recommendations are developed for the issues of market regulation and development.

Our professional activity is aimed to care human life and health therefore Good Quality Assurance at all stages of the Product Life Cycle is very important for us.

Drugs production organization on Pharmstandard group manufacturing sites is fully compliant with GMP requirements. The Quality Management Systems of the company’s plants integrate into a Product Quality Management System at all stages of its life cycle. The Quality Management System’s development and improvement are based on the process and project approach, risk-oriented thinking and are based on the best domestic and international experience in the field of Good Pharmaceutical Practices.

Paying paramount attention to Product Quality issues, Pharmstandard acts as the General Partner of the 4th All-Russia GMP conference.

We see interest to this Conference not only in our country, but also abroad. The increasing number of participants in the event and the geography of their activities testify to this. The annual business program of the Conference is devoted to the most topical issues of the pharmaceutical market in Russia, international regulatory practices, and trends in inspection.

We wish the Conference further successful development, and we wish all its participating an effective dialogue, new experience and promising cooperation.

 Grigory Potapov
Chief Executive Officer
Pharmstandard JSC

Greetings from Natalia Volovich


The Russian market is strategically one of the most important for Gedeon Richter, we strive to contribute to the growth of life quality and life expectancy of Russians. Over the decades of work in this region, the company has been able to prove its commitment to the interests of patients as well as the pharmaceutical and healthcare industries in general.

Today it is safe to say that most of our products have already proven themselves in the clinical practice of Russian specialists and are widely used. And we, in turn, make every effort to ensure that our drugs are available for our patients.

Along with the achievement of high efficacy, safety and availability of our medicines, Gedeon Richter strives to maintain a consistently high level of quality of our products. To do so we introduced a unified multi-stage control system at each of our factories, which was approved by Russian and foreign regulators.

We are pleased that for the past four years the GMP Conference with International Participation has brought together industry experts and stimulated a productive dialogue to discuss topical issues for the benefit of the industry.

I wish you a successful conference and fruitful work! Thank you!

Natalya Volovich
Deputy Director, Head of Registration Department
Gedeon Richter, Moscow office

Director Shestakov welcomes participants of the IV All-Russia GMP Conference

Welcome to all the participants of the IV All-Russia GMP Conference!

Шестаков В.Н.

The annual event to be held in the 3rd quarter of the year – the All-Russia GMP Conference – is not just a good tradition, but indeed an essential practice of the Russian inspectorate to demonstrate its openness to the dialog with drug manufacturers. Every year the event is attended by more and more professionals and experts of the industry, with a greater number of international participants as well. We, as ideologists and founders of the GMP Conference, are pleased to see among the latter our foreign colleagues from the inspectorates.

This year, the venue of the Conference will be in the most remote corner of our country – Kaliningrad region. Even though the venue was selected by voting by attendees of the previous event, I am confident that it is not a mere coincidence that this region has won. As in other cities hosting the GMP Conference, the pharmaceutical industry is very well established here: in the town of Bagrationovsk, there is the very first in Russia private industrial park «Ecobaltic» being very successful, and the basis of it is manufacture of pharmaceutical products and medical devices. One more peculiar feature of the region is the border with the EU, which means efficient export of the products manufactured. On the other hand, this is also additional stress in part of compliance with the GMP requirements not only of Russia, but of the EU as well.

I am sure that, within the very busy agenda of the Conference, these and other relevant topics will be extensively raised in pursuit of the effective development of the pharmaceutical industry.

I wish all the participants of the IV All-Russia GMP-Conference with international participation effective and exciting work, new discoveries and achievements in manufacture and provision of patients with high-quality and efficient medicines.

Best regards,
Director of FSI «SID & GP»
V.N. Shestakov

Director Shestakov welcomes participants of the III All-Russian GMP Conference

Dear participants! On behalf of the State Institute of Drugs and Good Practices, it is a special pleasure for me to greet representatives of the pharmaceutical community.

Шестаков В.Н.

Due to increased attention to such a strategic issue as GMP-inspections, this will no doubt become a conference of a great magnitude. Almost 1 000 representatives of different nations plan to honor this professional event which is the record number compared to previous years. Regular pattern of the conference and its increased significance clearly demonstrated the global involvement of all stakeholders in the pharmaceutical industry, and international solidarity of countries on the way to safety and efficacy of medicines.

The capacity of the Russian pharmaceutical market has boosted in recent years. Now that the domestic market has reached the international level, Russian products and Russian inspectorate are widely known around the world, great efforts have been made to garner international kudos. A new challenge is to hold down the fort and choose an appropriate strategy to win the global market.

Harmonization of mutual recognition rules – as we know – is not a simple task. To succeed in this course, effective integration of trans-border associations cannot be underestimated. Conventions and events like this GMP conference are naturally triggered by globalization of pharmaceutical interests and development of export potential.

I am certain that the busy conference schedule and planned discussions will help develop strategical policies and will produce a favorable impact on entire pharmaceutical industry.

September 20-22, in the city of Yaroslavl for the Yaroslavl pharmaceutical cluster will be held I all-Russian GMP conference

September 20-22, in the city of Yaroslavl for the Yaroslavl pharmaceutical cluster will be held I all-Russian conference of GMP.
the event is organized by the Ministry of industry and trade and the Federal budgetary organization “State Institute of drugs and good practices”, with the participation of enterprises of the Yaroslavl pharmaceutical cluster and of the Association of modern pharmaceutical industry and innovative medicine of the Yaroslavl region.The conference aims to create an open discussion platform to exchange experiences and discuss practical issues arising in the process of implementing the rules of good practices between participants of the Russian pharmaceutical market, authorities, professional associations and communities.
One of the important problems to be solved by the conference – ensuring maximum openness and transparency in relation to the requirements of good manufacturing practices, applied aspects of its implementation, preparation for inspection for compliance with GMP.

First national GMP, the conference will bring together leading experts in the pharmaceutical industry, representatives of state authorities, heads and specialists of pharmaceutical companies, representatives of associations, medical and patient communities, experts in education and training the pharmaceutical industry.

the the conference is invited to discuss the following key topics:


  • Potential and investment attractiveness of the region for the industry.
  • the

  • evaluate the current status of the implementation of GMP, specifics, difficulties, solutions.
  • the course of the inspection, the key inconsistencies, the recommendations from the Inspectorate.


  • Training of personnel reserves in the industry, the implementation of the principle of continuous training of pharmaceutical employees: professional and educational standards, approaches to the construction of programs of additional education, use of new media and technology in education.
  • the

  • Cooperation “producer – doctor – patient”, ensuring high standards of quality in the production of Russian medicines.
  • the

  • Normative-legal regulation in the field of good practices.
  • Interagency cooperation in quality assurance of medicines.

The conference program includes acquaintance with the work of leading companies in the industry and visiting their production sites, and conducting additional educational module with GMP certificate.
Prepared by the press service of the Centre for corporate communications S-GROUP, technical organizer of the conference.


«R-Pharm» has opened in Yaroslavl innovative production of biological products using technology at GE Healthcare

On the basis of the pharmaceutical complex of the group of companies “R-Pharm” for the production of finished dosage forms in Yaroslavl, a solemn opening of a new line for the production of therapeutic proteins. The ceremony was attended by Chairman of the Board of Directors of group of companies “R-Pharm” Alexey Repik and CEO Vasily Ignatiev, Deputy Minister of industry and trade of the Russian Federation Sergey Tsyb, Director of Department of development of pharmaceutical and medical industry of Ministry of industry and trade of the Russian Federation Olga Kolotilova, Director of the Department of drug supply and regulation of medical devices circulation of the Ministry of health of Russia Elena Maksimkina, Director General of fsbi “State Institute of drugs and good practices” Vladislav Shestakov as well as Director of GE Healthcare Life Sciences in Russia/CIS Andrey Demurin. The event was held in the framework of the first national GMP conference in Yaroslavl.The desire to reduce operating costs, and hence reducing the cost of treatment of patients requires improved ways of producing drugs. Biopharmaceutical companies worldwide are looking for possibilities of increasing production flexibility in full compliance with the international quality standards. To this end, the company “R-Pharm” has decided to equip the line of production of therapeutic proteins in Yaroslavl integrated FlexFactory platform, the development division of GE Healthcare Life Sciences. Total investment in the project of “R-Pharm” has made over 1.5 billion rubles.
Press release 20 St R FARM Yaroslavl L B5A6430
This platform is based on the use of innovative, so-called “disposable technology”, allows you to quickly accumulate considerable volumes of monoclonal antibodies and other biotech products. Unlike standard solutions, “disposable technology” enables significant savings of resources and time. At all stages of production (cultivation, purification, chromatography) are disposable items that after use are promptly disposed of and replaced by new ones, without requiring time-consuming and costly cleaning. “Disposable technology” provides flexibility in the modification of production processes, and if necessary, the possibility of rapid changes in the production of new products. Unified automation system enables to control the whole course of production and adjust individual processes, which facilitates the mounting and installation of the equipment and its use in the enterprise. In addition, “disposable technology” allow to exclude the possibility of contamination of the resulting products and to reduce the cost of cleaning the process line after each new launch of a series of the drug.

FlexFactory opens the possibility of the most rapid commissioning: from initial design to full certification and production readiness to launch takes an average of 12 months, significantly less than required to create a traditional line. In Yaroslavl the installation of innovative equipment began in the spring of 2015, and by October was confirmed by its functionality. This will allow us to begin pilot production and first industrial series for pre-clinical testing in early 2016.

The launch of a new line of biopharmaceutical drugs is an important step for serial production in Russia, of biological products, including innovative products and bio analogues with high export potential. The production line was qualified in accordance with the requirements of GMP.

According to Sergey Tsyb, Deputy Minister of industry and trade of the Russian Federation, “domestic companies actively use the support tools in the framework of the state Program on development of pharmaceutical and medical industry of the program “Pharma-2020”. Part of this program is the company “R-farm”, one of the largest investors in the region. Open platforms such as FlexFactory is an argument in favor of the fact that we chose the right guidance, goal setting, and so companies are actively helping us to reach those figures who stand before us in the framework of “Pharma-2020″”.

“The prospect presented in the Yaroslavl production technology of proteins is that biological products can be used to treat large number of diseases. Moreover, it is through the practical application of such drugs in modern medicine was able to find answers to many unanswerable are still problems in the field of treatment of oncological, cardiovascular, immune and other socially significant diseases, said during the opening lines Chairman of the Board of Directors of”R-Pharm” Alexey Repik.

“We are pleased to announce the launch of an innovative line for the production of highly effective drugs for the treatment of autoimmune diseases and cancer. The need of the health care system in modern treatment methods continues to grow, underlining the need for new development and improvement of diagnostic and therapeutic aid,”– said General Director of “R-Pharm” Vasily Ignatyev “R-Pharm”.

Andrew Demurin, Director of GE Healthcare Life Sciences in Russia/CIS, said: “We are proud to offer innovative solutions for key challenges facing the pharmaceutical industry in the context of the state program “Pharma 2020”. The discovery in Yaroslavl production line, equipped with GE Healthcare technology FlexFactory is an important event for national healthcare. The line capacity is 2000 liters per year – that means that the Russian patients will be provided with high-quality drugs in sufficient quantity.

About group of companies “R-Pharm”

“R-Pharm” – Russian high-tech pharmaceutical company. The company’s mission is to ensure the availability of innovative therapies for patients in Russia. The employ more than 3500 highly qualified specialists. “P-farm” on the territory of Russian Federation, CIS, USA, Germany, Japan, Turkey and India. There are more than 60 branches and representative offices. The main activities are: production of finished dosage forms, active pharmaceutical ingredients of chemical nature and biotechnological substances, research and development of innovative medicines and technologies, bringing to market modern medicines, as well as education and training of specialists for pharmaceutical industry and health care.

About FlexFactory

FlexFactory is a fully integrated optimized a biotechnological platform that allows manufacturers to quickly and easily create automated biopharmaceutical manufacturing. Line enables a quick start of production of key biological drugs such as monoclonal antibodies and vaccines, from the cultivation of the cell culture and ending with the preparation of bulk formulations. Equipment FlexFactory is based on the “disposable technology”, which allows to achieve significant savings in time, capital costs and industrial costs in comparison with traditional stainless steel equipment. The line includes the equipment of technological processes, as well as all necessary automation components and control for the complete cycle of production of biological preparations. The ability to scale the FlexFactory platform significantly reduces the time of transition from production of one product to another. It can also be modified according to customer requirements to match the tasks of new or existing industrial enterprises. The experts from GE Healthcare Life Sciences to conduct training and provide consulting and service support on all stages of creation and operation of the equipment.