The Conference opened with a plenary session under the motto “Strong Regulator – Strong Industry” moderated by Dmitry Galkin, Director of the Department of Development of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, and Vladislav Shestakov, Director of the Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of Russia (FSI «SID & GP»).
Today, global healthcare is facing new challenges. The authorities are required to make efficient and timely decisions and improve legal framework to meet the interests of both the industry and healthcare consumers. COVID-19 pandemic has proven how important it is to find ways to accelerate development and registration, market launch and increase in production of urgently needed drugs and medical products.
Dmitry Galkin emphasized that expanding product range calls for compliance with requirements that, in good industrial practice and in all other good practices, ensure quality, efficiency and safety, and the result of all actions, both in production and in treatment, must be focused on strengthening the healthcare system. He also underlined the importance of multi-level interaction:
“Amidst the increased pressure on the healthcare system, strong regulation allows pharmaceutical industry to maintain high standards and produce high-quality, safe and effective medicines. Indeed, there are no double standards in matters of quality. The motto of the plenary session and the entire conference is “Strong Regulator – Strong Industry”, which in the modern world is more relevant than ever,” Dmitry Galkin said.
Vladislav Shestakov noted that amid the fight against coronavirus infection, a lot of implemented projects have demonstrated the effective interaction of authorities, scientific community, and business. And such work has been carried out all over the world. Regulators in most countries are faced with the question of how to quickly change the system in order to help the entire healthcare work efficiently.
At the session, representatives of the regulatory authorities of the EAEU countries, Cuba, Algeria, Australia, Hungary, the Dominican Republic, Bangladesh, as well as European and African Unions, shared their pandemic strategies and steps taken to overcome the crisis in their territories. In particular, their reports concerned the system of state regulation of new drug circulation.
Summing up the series of speeches, moderators formed the general opinion that at this stage, there is no doubt about the need for a balanced, reasonable approach at all stages of drug circulation, and regulators should promote best practices to meet the needs of healthcare with high-quality and safe products.
At the end of the plenary session, important agreements were signed. FSI «SID & GP» of the Ministry of Industry and Trade of Russia, the Eurasian Academy of Good Practices and Nomix LTD signed a tripartite document, according to which the FSI «SID & GP» of the Ministry of Industry and Trade of Russia transfers to the Academy the rights to implement training programs using the “Virtual Plant 2.0” project, a virtual reality plant for the production of solid form drugs.
The second agreement on the development of reference materials for biotechnological drugs was concluded between the National Centre for Reference Materials and the Federal Research Centre “Fundamentals of Biotechnology” of the Russian Academy of Sciences.
The partners of the VI All-Russian GMP Conference with international participation:
- General partner: Natsimbio holding of the Rostec State Corporation;
- Strategic partners: Roche, Gedeon Richter;
- Official partner: Amgen;
- Conference partners: Teva, MSD Pharmaceuticals, Novartis Group Russia, Novo Nordisk;
- Session partners: Petrovax Pharm, Abbott, PRO.MED.CS Praha a.s, Akrikhin, Association of Veterinary Pharmaceutical Manufacturers (AVPHARM);
- Special partners: PharmEco Group, Nanolek, Boehringer Ingelheim Russia, Pharmaceutical company “Bosnalijek”, Samson-Med, Binnopharm Group;
- Linguistic partner: Janus Life Sciences;
- Online exhibitor: Shimadzu.