The VI All-Russia GMP Conference with international participation will be held on 22–24 September 2021 in a hybrid format. The offline part will take place in St. Petersburg, in the business space of Park Inn by Radisson Pribaltiyskaya Hotel. The event is organised by the Ministry of Industry and Trade of the Russian Federation, jointly with FSI State Institute of Drugs and Good Practices. S-GROUP Corporate Communications Centre will act as an operator.
The Conference will raise topical issues related to good production practices, integration processes in the single EAEU market, Russian export development, as well as regulation of the entire life cycle of a drug.
The plenary session “Strong Regulator – Robust Industry“ will focus on the necessary structural approach for taking the Russian pharmaceutical industry to the international level. Representatives of Russian authorities, the Eurasian Economic Commission, regulators of the member states of the Eurasian Economic Union and regulatory bodies of the European Union, pharmaceutical companies and industry associations will also discuss the actions of regulatory bodies during the pandemic and the experience of interdepartmental interaction. Experts will analyse the decisions made and assess the implementation results of legislative initiatives in the Russian and foreign markets. The moderator of the plenary session, which starts on 22 September at 10 am, will be Vladislav Shestakov, Director of FSI State Institute of Drugs and Good Practices, Ministry of Industry and Trade of Russia.
Besides, on the first day of the Conference, a panel discussion “New Elements in Regulating Drug Circulation Within the Eurasian Economic Union” is planned. Among the most discussed questions are acute issues of integration within the framework of the single pharmaceutical market of the EAEU: current changes in regulatory legal acts, new third-level documents, issues of maintaining unified EAEU registers, the Eurasian Economic Union Pharmacopoeia. Representatives of Russian government agencies and regulatory authorities of all EAEU member states will take part in the discussion.
Among the important tasks for the today’s domestic pharmaceutical industry are support for domestic developments, creation of full cycle productions, development of a system of state standard reference samples in Russia. This will be the focus of the panel discussion “Current Developments of the Pharmaceutical Market: Time and Place for Systemic Expertise.”
The Conference programme on 23 September will be opened by the panel discussion “Holistic View Pertinent to Regulation of GxP Practices” where experts will discuss the organisational and legal issues of regulating a wide range of good practices: GLP, GCP and GDP. The necessary steps to systematise the approaches to production and circulation of biologically active additives will also be discussed.
Another important topic annually covered at the All-Russia GMP Conference is the inspection of manufacturers of medicinal products for veterinary use. In September 2021, a separate session will also be devoted to this area.
With the support of Akrikhin, on the second day of the forum, a panel discussion “Regulatory Issues Pertinent to Export of Russian drugs” will take place. The session will include the review of foreign markets, assessment of the export potential of Russian pharmaceutical manufacturers and showcasing of working with foreign distributors. Faiza Yagudina, Quality Director at Akrikhin, will make a report on the preparation of registration dossiers and passing foreign GMP inspections.
In addition, on 24 September, offline Conference participants will have an opportunity to visit master classes “Technology Transfer. Regulatory Requirements”, and “Technology Transfer. GMP Inspections. Practice of Technology Transfer from the Inspector’s Point of View.” The practical part of the Conference will be attended by representatives of the Ministry of Industry and Trade of Russia and FSI State Institute of Drugs and Good Practices of the said Ministry, as well as foreign regulatory agencies and pharmaceutical companies.