The objective of the Project was to establish the system of post-graduate, internationally recognized and compliant education, and training of initially 120 - 135 regulatory affairs specialists from the institutional members of TEMPO and BII-RABIITT in the field of organization and performance of preclinical trials.
The general tasks of the Project were determined as follows:
Task 1. Comparative analysis of the educational and training systems for certification of preclinical investigators in Russia and abroad in accordance with GLP and other international standards.
Task 2. Preparation and Performance of TEMPO GLP preclinical competency building activity.
Task 3. Promotion of the GLP training course and preparation of a report on the project development.
The Project was realized in tight cooperation of TEMPO with the Regulatory Affairs Professional Society (RAPS) engaged by BII to serve as a collaborator providing needed expertise in the systems of training, education and knowledge resources for GLP-preclinical compliance specialists. There were several working meetings of RAPS and TEMPO experts organized by a management of BII and CRDF, in the USA (San Francisco, CA; Washington, DC) and Russia (Moscow; Pushchino).
The GLP curriculum was developed by the group of experts of TEMPO, IBCh RAS and MMA, and was recognized by RAPS Advisory Committee to be fully corresponding to RAPS' educational standards in GLP.
The TEMPO GLP curriculum has been registered and ratified by Educational-Methodical Association on Medical and Pharmaceutical Education of Russian high schools (EMA) as the Program of thematic advanced training course “Preclinical Toxicological Investigations of Drugs (GLP)”. The registration of the program by EMA confirms the correspondence of the program to the Russian educational standards and supports the issuance of appropriate Russian State diplomas to the successful trainees in accordance with established Russian legislation.
In accordance with the purposes of the Task 1 of the Project search and analysis of Russian training and educational programs on preclinical trials have been carried out. From the analysis it can be concluded, that to the moment of Project start there was no permanent system of improvement of professional skills of the preclinical trials experts in Russia. Training and education of preclinical experts was non-permanent and carried out in the frame of independent training seminars and workshops in several Russian institutions.
The training sessions were carried out on the basis of Pushchino branch of IBCh, possessing facilities for providing of lectures and practical training. Materials for trainees of the GLP training sessions were prepared. The set of materials includes:
· The day-by-day agenda of a training session with an indication of all events; the plan of practical training in Biological Testing Laboratory of FIBCh RAS.
· Special literature and methodical materials:
- Selected chapters of “The Manual on Experimental (Preclinical) Investigation of New Pharmacological Substances”, Moscow, 2005.
- The text of the Order N 267 of the Ministry of Public Health of the Russian Federation (“On the ratification of rules of laboratory practice” of June 19, 2003).
- Toxicology of Drugs. Guskova T.A., Moscow, 2003.
- Guskova T.A., Fisenko V.P. Prognosis of safety of drug application in clinic on the basis of preclinical toxicological experiments. Bulletin of the Center on Scientific Examination and State Control of Drugs. 2003, N1.
- GLP Terms and Definitions developed by RAPS.
- A folder of the GLP investigation documentation and examples of Report Template, Master Schedule list, Report Checklist, Monitoring Autoclave Daily Form, Balance Standardization Form, Sampler Test Form, Equipment Maintenance Log, Instrumental Inventory Form.
· Examination tests and one of the thirty different variants of situation tasks.
· Booklets and publicity materials of TEMPO and/or RAPS.
Printed copies of all presentations were prepared and given to the trainees during the training session. The book “Guide for the Care and Use of Laboratory Animals” (National Academy Press) in Russian was presented by CRDF to be distributed among trainees.
Four GLP training sessions were carried out by TEMPO in 2005:
1 session 7 – 17 February (30 trainees)
2 session 14 – 22 March (37 trainees)
3 session 18 – 26 April (30 trainees)
4 session 5 – 13 September (33 trainees).
Leading Russian experts in preclinical safety and toxicology testing were participated in educational process. RAPS has realized negotiations with foreign speakers and invited them to participate in the first training session to highlight several specific topics of the program. Practical training in the Biological Testing Laboratory (FIBCh) as well as round-table discussion of situational tasks and preclinical trial protocol development was carried out. During the visit to Research Center for Toxicology and Hygienic Regulation of Biopreparations (Serpukhov) the trainees were acquainted with its facilities and laboratories.
The final exam was organized by TEMPO and MMA on the last day of each training session. The exam was consisting of several stages including testing, discussion of situational task and individual interview of trainees. All trainees passed the exam successfully and were awarded with TEMPO-RAPS and MMA certificates.
Roundtable discussion “Preclinical Trials – the Basis for Drug Safety and Quality Assurance” in the frame of the Project was organized by TEMPO. The event was held on June 15, 2005. 42 people from 23 institutions including representatives of non TEMPO member organizations and Russian Ministry of Healthcare and Social Development, participated in the roundtable discussion. Current situation on preclinical trials implementation in Russia was widely discussed as well as efforts to bring the preclinical trials in correspondence with international standards and requirements GLP. The perspectives of GXP educational system in Russia development initiated by TEMPO, were discussed.
Basing on the results of the Project further development of TEMPO efforts to promote harmonization of preclinical trials in accordance with GLP standards and requirements in Russia as well as TEMPO activity in building GLP preclinical capacities, is planned. The Project is followed by the TEMPO Proposal on Establishing the Basis for the Regulatory System GLP for Preclinical Investigations and Clinical Trials of New Drug Preparations in Accordance with International Standards and Requirements which was already sent to BII consideration. Another TEMPO proposal on TEMPO Facilitation of the creation of a RABIITT system of internal GLP standards and internal audit and Preclinical marketing alliance should also contribute to the main purpose of the TEMPO activity - to enable the performance by TEMPO institutions of preclinical trials of drug and vaccine candidates in accordance with international GLP standards in order to:
- Enable preclinical experimental data on promising drug and vaccine candidates arising from TEMPO institutions to be considered by U.S. / Western pharmaceutical companies, and / or,
- Enable TEMPO institutions to perform contract preclinical toxicology and efficacy studies for U.S. / Western pharmaceutical and biotechnology companies.
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