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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 ...
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