Transcript Слайд 1 - nptemp.ru

NP “TEMPO”
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.
NP “TEMPO”
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 preclinical 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
NP “TEMPO”
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
NP “TEMPO”
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
NP “TEMPO”
Current situation 
YES
NP “TEMPO”
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
NP “TEMPO”
NP “TEMPO”
Current situation 
YES
NP “TEMPO”
NP “TEMPO”
Data bank of
pre-clinical
investigators
Association of
independent
experts and
auditors
ISTC
BioIndustry
Initiative
RAPS
Combined efforts
in development of
the National System
sector
NP “TEMPO”
Technical
inspection
Monitoring
Publication of
the literature
and documents
Combined efforts
in development of
the National System
sector
Education
Audit of
investigations
NP “TEMPO”
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”
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.