Director of the FSI “SID & GP” Vladislav Shestakov led the Plenary session of the 11th GMP Conference with international engagement

The 11^th Russian GMP Conference, dedicated to the new decade of Good Manufacturing Practice standards, has kicked off in Stavropol. The event which has established itself as one of the key platforms for open dialogue within the pharmaceutical industry, brought together the regulatory agencies from the EAEU member countries, heads of the ministries, and leading Russian and international industry experts.

Opening the Conference, Director of the FSI “SID & GP” Vladislav Shestakov noted the symbolic significance of the chosen venue: “Our conference travels across the country, and today we are being hosted by Stavropol — a region that strengthens healthcare sector just as effectively as we strengthen quality standards.” By tradition, the GMP Cup was handed over to the representative of the host region – Imran Omarovich Aidamirov, Minister of Energy, Industry and Communications of Stavropol Krai.

The business programme of the Conference is intended to cover all strategic levels – from supranational regulation to practical steps for the development of production and quality control.

The speakers of the Plenary session “Strategic priority: modern pharmaceuticals manufacturing” were: Chinara Mambetalieva, Deputy Director of the EEC Technical Regulation and Accreditation Department; Dmitry Galkin, Director of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of Russia; Valentina Kosenko, Head of FSBI “SC EEMP” of the Ministry of Health of Russia; Dr. Solomon Onen, GMP specialist at the African Medicines Agency (AMA); Dmitry Kudlai, Science Director of SPA “Microgen” (“Nacimbio” holding, Rostec State Corporation) and Alexey Torgov, Deputy Director General, Corporate Relations and Communications, JSC “BIOCAD,” representative of the Association of pharmaceutical manufacturers of the EAEU.

The Conference attendees discussed changes in regulation of circulation of medicines within the EAEU, new requirements coming into force, and the need to continue work on harmonisation of regulatory approaches in the member states. Particular attention was given to achieving technological sovereignty, local production, development of nuclear medicine, and production of vaccines and biotechnological medicines.

Within the international track, the speaker from the African Medicines Agency (AMA), which unites the African national regulatory authorities with the goal to harmonise rules and accelerate access to quality medicines on the African continent, delivered a presentation on creation of the African Medicines Agency.

The Conference also focused on immunobiological medicines as the foundation of national biosecurity including export potential of the Russian pharmaceutical industry. Experts emphasised that GMP is becoming the common language spoken by manufacturers and regulators worldwide, and trust in the quality system is an essential prerequisite for entering new markets.

“We discussed such topics as import substitution and local production, technological sovereignty, interagency cooperation, global trends and new regulatory initiatives beyond the EAEU. And running through it all was a common theme: quality, safety and accessibility of medicines. This is a shared responsibility,” wrapped up Vladislav Shestakov.

At the conclusion of the plenary session, a three-day vote to select the host city for the 12^th Russian GMP Conference was opened. The results will be announced at the end of the third day of the Conference.