10.07.2017 – 11.07.2017 in St. Petersburg, the training school “Actual issues of regulatory regulation of preclinical, clinical trials and registration procedures” was organized by the St. Petersburg Chemical and Pharmaceutical Academy (SPCPA) and the St. Petersburg Institute Pharmacy.
14 reports were delivered within the framework of the training school. Three round tables were held at which the experts of the FGBU “NTSESMP” of the Ministry of Health of the Russian Federation gave explanations on the approaches to preclinical research within the framework of the EAPS and the requirements for the preparation of the registration dossier. Particular attention was paid to the preparation of a preclinical research program for preparations of various groups, questions were raised in which cases literature reviews could be an adequate alternative to research. The participants of the event were specialists of companies involved in the process of creating drugs from substance manufacturers to CRO organizations: ANO SRC “St. Petersburg Institute of Bioregulation and Gerontology”, “Active component”, Bionorica, VERTEKS, Harmony, PHARMACY HOUSE, Dr. Reddi’c Laboratories Ltd. ., IBA-groups, RIC-Pharma, Samson-Med, Technology of Medicines, Farmamed, Pharmproject, ETC, Dalhimfarm. During the training school, the participants visited the Excellence Center for the development of innovative medicines and technologies, including a technology transfer center and the GMP training center of the SPCFA and the vivarium PHARMACY HOUSE. The event was attended by 60 participants.