Conference «Biomedical Cell Products – Development, Registration, Production»
Conference «Biomedical Cell Products – development, registration, production» was held on 18-19 May in Saint Petersburg. Specialists of IQDEMY Chemicals took part in in the discussion of today’s trends and problems in the development of cellular technologies, the prospects for their introduction into clinical practice. Leading Russian experts in biomedicine reported at the conference. Most attention was paid to Federal Law No. 180-FZ dated 23 June 2016 «On Biomedical Cell Products» developed and introduced by the Ministry of Healthcare of the Russian Federation. This Law governs development, pre-clinical and clinical studies, examination, state marketing authorization, quality assurance, manufacturing, marketing, storage, transportation, use, destruction, import and export of biomedical cell products to and from Russia for the purposes of prevention, disease diagnostics and treatment, maintenance of pregnancy and rehabilitation, and biomaterial donation. The law defines for the first time such important terms as ‘biomedical cell products’, ‘cell line’, ‘cell differentiation’, ’biological material donor’, ‘biomedical cell product safety’, and ‘biomedical cell product efficacy’. Thus, this law should become a legal base for bringing brand new medical products to the market. It is aimed to establish complex GMP (good manufacturing practice) – and GTP-oriented (Good Tissue Practice) facilities to produce effective and safe cell products. The law «On Biomedical Cell Products» was put into force on January 1st, 2017 and it is especially important to understand all aspects and consequences of this law for further development of the industry, commercial use of products which previously were only the subject of scientific research. Some topics of conference reports are: physiology of regenerative processes; stem cells in regenerative medicine; propensities of pluripotent stem cells; results of experiments; application of cellular structures for tissue engineering; polymers and composites for cellular technology. Overall, the conference was interesting and productive, important contacts for further cooperation have been established. Participation in such events allows specialists of IQDEMY Chemicals keep the track of events in a dynamically developing field of regenerative medicine and maintain a high level of competency.