The Russian delegation takes part in the 34th meeting of Working Group of OECD on GLP
Director of the Department of regulatory policy of the Ministry of Economic Development of the Russian Federation Alexander Litvak and the head of the Coordination Center for the implementation of the GLP principles of the OECD of the National Institute for Accreditation of RusAccreditation Martha Bouche took part in the 34th meeting of the Working Group of the Organization for Economic Cooperation and Development (OECD) on Good Laboratory Practice, which was held on February 17-18 in Sendai (Japan).
Alexander Litvak made a presentation on the implementation of a two-year project between the OECD and the Russian Federation “Providing technical assistance on improving the Russian system of good laboratory practice”. As part of the project, in 2018, Russian GLP inspectors and test centers' personnel received the training by OECD experts. Russian inspectors also took part as observers during the GLP inspections by the UK and Finland monitoring authorities. In 2019, a comprehensive audit of the Russian GLP system was conducted as regards its compliance with OECD standards. The assessment included an analysis of Russian legislation, the documentation and procedures used, the work of the monitoring body (RusAccreditation), as well as the assessment of the work of inspectors during a full inspection of the Russian testing center. According to international experts, the Russian system meets the requirements of OECD documents.
The meeting of the Working Group included a discussion on drafts of new documents of the GLP system of OECD related to the development of an assessment system for national GLP monitoring bodies, the integrity of non-clinical research data, the use of cloud solutions in research, clarification of a number of issues on the implementation of GLP principles in the activities of testing centers.
The working group identified plans for further work in the field of GLP and the development of mutual data recognition system for 2020-2021.