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

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

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

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.

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.