Participation in the seminar “Rules of clinical trials: an introduction for researchers”, Moscow
22 May 2013, Wednesday 00:00
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Employee of the Department of vitreoretinal and laser surgery PhD Gil'manshin I Tr, as one of the main researchers of the program LUMINOUS, participated in the seminar “Rules of clinical trials: an introduction for researchers” (16 - 17 may), organized by Institute of clinical research (Moscow).
In connection with the trend of total globalization and international integration of the Russian Federation is becoming an integral part of the world, including in matters of scientific and clinical research in medicine, which has also a clear international norm prescribed in the rules and conventions. There is a need for training in this area of expertise.
This course included lectures and discussions on the research problem in clinic of new pharmacological agents before and after their official registration. The presenter of the course – head of the Department of clinical pharmacology of Russian peoples friendship University Fitilev S. B.
The seminar discussed the main issues of the stages of drug development
drugs, phases of clinical studies of the drug, design and planning of clinical studieslegislative and ethical aspects of clinical research.
In the international medical research practice the system of regulations and standards of Good Clinical Practice (GSP), reflecting the basic legislative and ethical aspects of test drug.
Given that the Ufa scientific research Institute is one of the main organizations that have accreditation for the international research in the field of drug trial, gaining experience in the system of Good Clinical Practice contributes to further research activities in this aspect.