REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot121210.21518/1561-5936-2018-3-40-44Original ArticleContribution of the european forum for good clinical practice to improvement of the clinical trial process in Russia and other post-soviet countriesKubarO. I.noemail@neicon.ruSaint-Petersburg Pasteur Research Institute of Epidemiology and Microbiology031220183404418032022Copyright © 2018,2018The article presents the material on the progress in the promotion of the international standard Good Clinical Practice (GCP) in the Russian Federation and other post-Soviet states. Particular attention is paid to the contribution of the European Forum for Good Clinical Practice (EFGCP) to the process of implementation of GCP in the region. Examples of long-term cooperation of authorized facilities and the regional authorities with the EFGCP are given. The article shows the unique role of the European Forum for Good Clinical Practice in performing an independent, multidisciplinary and multinational analysis of the effectiveness of various GCP components with the consistent implementation of all approaches and rules in the course of scientific and technical improvement in conducting clinical trials. There are examples of mutually beneficial sharing of information and experience in improving the international clinical trial practice with the participation of the post-Soviet countries.good clinical practiceethical principles for the protection of human subjects of researchimprovement of the clinical trial processcooperation with the European Forum for Good Clinical Practice (EFGCP)надлежащая (качественная) клиническая практикаэтические принципы защиты прав участников исследованиясовершенствование процесса проведения клинических исследованийсотрудничество с Европейским форумом по качественной клинической практике (EFGCP)1.Кубарь О.И. Гарантии и условия соответствия универсальным этическим стандартам проведения клинических исследований в РФ. Биоэтика, 2017, 2 (20): 32-35.2.Кубарь О.И., Юдин Б.Г, Никитина А.Е., Владимирова Е.Ю. Этические и законодательные тенденции в области биологии и медицины в государствах-участниках СНГ Здравоохранение, 2009, 10: 46-60.3.Этическая экспертиза биомедицинских исследований в государствах-участниках СНГ (социальные и культурные аспекты). Под редакцией: Кубарь О.И., Микиртичан ГЛ., Никитиной А.Е. СПб.: Феникс, 2007. 406 с.4.EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe. International Journal of Pharmaceutical Medicine (Pharmaceutical Medicine), 2007,1: 1-113.5.Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. WHO. Geneva. 1995.6.Kubar OI. Ethical review in the cis countries. efgcp newsletter. Spring/Summer 2008. p. 19.7.Kubar OI, Glasa J, Glasova H. Good Ethical Practice in Vaccine Research. Биоэтика, 2017, 1 (19): 21-25.8.Kubar OI, Mikirtichan GL, Ochkur OK. When trials start as life ends, Russia. efgcp newsletter. Autumn/Winter 2011. p. 6.9.Operational guidelines for ethics committees that review biomedical research. WHO. Geneva. 2000.10.Standards and operational guidance for ethics review of health-related research with human participants. WHO. Geneva. 2011.11.Tassignon J-P, Kubar OI. 20th Anniversary of the EFGCP A history of the European Forum for Good Clinical Practice. efgcp newsletter. Summer 2013: 5-8.12.Tassignon J-P, Tilekeeva U. Kyrgyzstan perspectives. efgcp newsletter. Spring/Summer 2008. p.18.13.The role of the quality assurance unit - audit working party efgcp 2008, 22 p.14.Web. Site EFGCP//http://www.efgcp.eu/Publications.