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Formation of the institutional framework and to ensure the creation of good laboratory practice in accordance with the requirements of OECD | 27-03-2013
The project is implemented for the Ministry of Economic Development of the Russian Federation.

Project Dates: March — May 2013

Project Goal:

The aim of the project is to ensure the creation of Good Laboratory Practicň (GLP) system in the Russian Federation in accordance with the requirements of the OECD in the context of optimization of licensing procedures for the handling of products.

The following scope of work is to be fulfilled under the project:
  • Preparation of proposals for optimization of access to the market of products, whose studies are conducted in accordance with the principles of GLP OECD.
  • Evaluation of potential risks and impacts of the Russian laboratories and other economic agents in connection with securing recognition of nonclinical laboratory studies conducted in accordance with the principles of Good Laboratory Practice OECD.
  • Drafting legal acts aimed to the implementation of the principles in the OECD GLP in national laboratory practice, including establishing administrative procedures for monitoring compliance with the principles of good laboratory practice and the requirements for laboratories
  • Elaboration of a draft methodology for the assessment of laboratories in the compliance with the requirements GLP OECD.
  • Evaluation laboratories for possible compliance with GLP OECD (not less than 25 laboratories) according to the developed methodology.
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