ABOUT THE CONFERENCE

The Conference is organized by the Ministry of Industry and Trade of the Russian Federation together with the «State Institute of Drugs and Good Practices».

Over the past years, representatives of the world pharmaceutical community from Russia, the USA, Austria, Spain, Croatia, Japan, Switzerland, Italy, Poland, Hungary, Romania, Mexico, the Great Britain, Cuba, Bulgaria, Kazakhstan, Kyrgyzstan, Germany, Brazil, Slovenia and other countries took part in the Conference.

Partners of the Conference are the largest Russian and international companies, leading industry publishers and professional communities.

Each year, the event takes place in a new region of Russia, which helps the organizers to demonstrate the best practices in various parts of the country, and the participants to get acquainted with the regional aspect of the organization of the healthcare system and medicines supply.

Welcome address of Vladislav Shestakov for the attendees and guests at the 9th Edition of the Pan-Russian GMP Conference

Dear colleagues, partners, attendees and guests of the 9th GMP Conference with International Engagement,

On behalf of the FSI «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of Russia, co-organizer of one of the key events of the year in the field of good practices, let me welcome you to the 9th Pan-Russian GMP Conference!

This year, we are meeting in the capital of Bashkortostan, Ufa, one of Russia’s largest cities and a major center for industry, science, education, and culture. Production of pharmaceuticals and medical devices has been actively developing in Bashkortostan, including the implementation of import substitution programs during the manufacturing of raw materials, used for packaging pharmaceuticals and medical devices. There is also a number of large pharmaceutical companies located in the region.

Today, the GMP conference is more than an industry event. This is a system-based project designed to develop good practices not only in our country, but also worldwide. The unfailing interest in this event shown by foreign partners, the growing number of foreign attendees and the expansion of the geographical coverage of the conference demonstrate that this platform has become important for the entire pharmaceutical network. This means that the path we have chosen, aimed at dialogue, harmonization and convergence, is the right one. Practicing openness with our partners allows us not only to confirm a high level of professionalism, but to exchange experiences and increase confidence in the Russian pharmaceutical industry.

This time, the conference agenda will include a discussion of the most pressing topics and current trends in industry development both inside and outside Russia. Representatives of Russian and foreign regulatory authorities and leading industry experts will focus on a number of issues of most interest to the industry, particularly, the production of pharmaceuticals, including, most certainly, legislative and regulatory practices in drug manufacturing, interdepartmental interaction and harmonization of GMP rules of the EAEU member states and other countries, aspects of various forms of entry into new foreign markets available to the Russian manufacturers.

This year, the attendees will be engaged in both traditional and new interactive forms of collaboration, including case studies, business simulation games and open international dialogue between all key industry participants.

I am positive that this year the 9th Edition of the Pan-Russian GMP Conference will not only serve as a platform for discussing crucial and topical issues related to industry development, working out consolidated and systemic solutions, but also a place for partner and friendly meetings, and an opportunity to experience the rich culture of Bashkortostan.

I invite you to attend the 9th Pan-Russian GMP Conference and wish everyone a fruitful conference!

Welcome address of Natalia Volovich, Deputy Director, Head of the Registration Department of the Gedeon Richter Representative Office (Hungary), Moscow

Dear colleagues, partners and participants of the IX All-Russian GMP Conference!

For almost 10 years an event of such scale has been bringing together many pharmaceutical industry professionals. Those who are eager to share their expertise while searching for the best solutions to improve regulatory practices.

Throughout this time Gedeon Richter company has been a regular participant and partner of this important event in the industry. Today good manufacturing practice is not just a set of rules and instructions but a complex puzzle involving many elements: from the quality of substances to the employees’ qualification at the production site. However, such a GMP puzzle is not static. It is constantly changing, being supplemented with new details and improvements. Which, undoubtedly, makes the regulatory process even more complex but at the same time – interesting! Each standard, each procedure is a unique component that, along with others, create a holistic picture of the safety and quality of manufactured drugs.

Throughout the conference we will be solving important problems, looking for new solutions, sharing experience so that every step in the production process is verified, letting the final product meets the highest standards.

I am pleased to welcome all colleagues – the conference participants who strive to make their professional contribution to improving the health and well-being of patients. I wish all of us productive meetings, inspiring ideas and effective solutions!

Welcome address of Dmitry Zaytsev, Chief Executive Officer JSC “Pharmstandard”

Good afternoon, esteemed organizers and guests of the IX Pan-Russian GMP Conference!

On behalf of Pharmstandard, I am pleased to welcome all participants of today’s landmark event for the industry. This year, the conference is titled «GMP — Continuous Development», clearly reflecting the ongoing processes.

It would not be an exaggeration to say that the pharmaceutical industry is one of the drivers of the Russian economy, which is currently on the path of dynamic changes. Continuous development of the institute of good practices and constructive dialogue between all participants in the pharmaceutical manufacturing are crucial to achieving success.

I would like to note the significance of the event taking place these days. The Pan-Russian GMP Conference, as already proven by many years of experience in holding it, is a working platform for interaction between all industry participants. Representatives of state regulatory authorities, experts in good practices, members of pharmaceutical manufacturing, industrial unions — all of us at this platform are looking for ways to harmonize and improve key processes for our industry. This includes evaluation of regulatory practices, discussion of issues related to licensing, auditing, development of quality management system, medicinal product manufacturing, activities of industrial unions, and features of entering the markets of other countries.

On the sidelines of the 9th Pan-Russian GMP Conference, I am sure that we will be able to discuss highly topical issues that pharmaceutical market participants face today, find common approaches to law enforcement practices and, in the format of an open discussion, come to mutual understanding and develop constructive solutions. I wish each of us to find seeds for addressing real challenges in the diversity of our colleagues’ experience.

Fruitful work to all conference participants!

ORGANIZERS

CONTACTS

ADDRESS

Ufa, Toratau Congress Hall

Zaki Validi str., 2
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