Organization and carrying out of pre-clinical safety testing of drugs in accordance with the international standards and requirements (GLP). The program of post-degree education and training for specialists working on pre-clinical trials.

WHO and FOR WHAT REASON is interested in realizing of educational and training program on pre-clinical trials in accordance with international standards and requirements (GLP) in Russia? THE STATE – to provide state policy in the field of drug safety THE ORGANIZATIONS which possesses laboratories for pre- clinical trials – to accredit the laboratories in Russia THE SPECIALISTS working on pre-clinical trials – to have a possibility to obtain quick promotion and a rise in salary

Current situation  There are NO  National system of pre-clinical safety investigations in Russia in accordance with international standards and requirements (GLP)  National educational and training programs for specialist working on pre-clinical trials  Certification programs raising the level of the specialist’s skill  The Specialists trained for the audit of pre-clinical trials

Current situation  There are  Licensed educational organizations and specialists able to develop educational programs, carry out the education and training and to issue the diploma (certificate)  Base laboratories on pre-clinical trials  Few specialists educated in foreign laboratories accredited on pre-clinical trials

Current situation  YES NO

Current situation  There is The organization - Non-commercial partnership “The center of new medical technologies “TEMPO”, which is able to combine the efforts of its participants for the decision of the education problem: I.M. Sechenov Moscow Medical Academy M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry RAS Research Center for Toxicology and Hygienic Regulation of Biopreparaions State Research Center of the Applied Microbiology

Current situation  YES NO NP “TEMPO”

BioIndustry Initiative Initiative RAPS Data bank of pre-clinical investigators Association of independent experts and auditors Combined efforts in development of the National System sector NP “TEMPO” ISTC

Combined efforts in development of the National System sector Monitoring Education Publication of the literature and documents Audit of investigations Technical inspection

Combined efforts in development of the National System sector THE PROJECT “Organization and carrying out of competency building on pre-clinical trials of drugs in accordance with the international standards and requirements (GLP) for specialists of the organizations – members of NP “TEMPO”

THE MAIN PURPOSE of the project is to enable the performance by TEMPO institutions of preclinical trials of drug and vaccine candidates in accordance with international GLP (good laboratory practices) standards. THE OBJECTIVE of the project is the post-graduate, international certification of 80 – 100 regulatory affairs specialists from the institutional members of TEMPO in the field of organization and performance of preclinical trials.