VIII всероссийская GMP-конференция

26-28 Сентября 2023


Площадка МВЦ «Экспо-Екатеринбург»

Welcome Speech of Lars Nielsen to the Participants of the GMP-Conference

Dear colleagues, pharmaceutical industry professionals, experts!  

This is the sixth time we are meeting together to discuss new challenges, current work issues, and prospects for the development of our industry. This is becoming a good tradition, and we are happy to be a part of it.  

Today, in the post-pandemic times, the issues of the vital medication availability come to the fore. The joint efforts of manufacturers and the government are aimed at supporting and accelerating the development rate of the domestic pharmaceutical industry, harmonising regulatory systems within the EAEU and, consequently, making modern treatment more accessible to patients.  

The last year demonstrated the commitment and readiness of those who stand guard over the national healthcare system to out-of-the-box solutions. In the summer of 2020, in full swing of the pandemic, the Roche manufacturing site in Basel, Switzerland, for the first time performed an online GMP inspection for the representatives of the Ministry of Industry and Trade of Russia and the Federal State Institution “State Institute of Drugs and Good Practices”. During the inspection, experts were able to visit and evaluate the manufacturing and storage areas for the substances and finished drug products, drug products quality control and microbiological laboratories, and utility and service areas in the video format. The Roche plant became the first foreign site that underwent an online GMP certification in Russia.  

This example proved once again the willingness of the Russian regulators to search efficient solutions and constructive cooperation in the interests of the patients. As a result of the timely completion of the manufacturing site inspection, Russian patients with spinal muscular atrophy will be among the first to start treatment with the company’s new product of risdiplam.    

Roche has been a strategic partner of the GMP Conference for several years. The longstanding partnership between the GMP Conference and Roche is based on the information exchange that promotes the improvement of manufacturing practices and higher accessibility of high-quality, efficient, and safe pharmaceutical products to Russian patients.  

Each and every year we are getting closer to achieving our common goal, that is to harmonise approaches to the development, production, and distribution of medicinal products and to introduce the best practices to advance the product quality not only to meet the needs of the Russian people, but also to create viable demand abroad.  

Therefore, strict compliance with GMP standards is an integral part and an indisputable priority in the operation, as well as a quality mark on the international level.  

I would like to thank the hosts of conference once more and wish interesting and productive work to all the participants!