The main goal of “TEMPO” educational programs is to create the basis for quality assurance of preclinical and clinical trials of drugs and vaccines in Russia in accordance with GLP standards.
The implementation of this goal is to be accompanied by standardization and harmonization of R&D in “TEMPO” members and the following activities: development of internal quality standards of R&D based on GLP, GCP, GMP, GPP regulations; training of specialists for preclinical studies and clinical trials; organization and monitoring of quality of preclinical studies and clinical trials; independent assessment of preclinical studies and clinical trials.
“TEMPO” is being successfully performing the program on implementation of international GXP standards in the Russian Federation in past four years, particularly by organizing trainings for specialist in regulatory affairs area. The main goal of “TEMPO” educational programs is to create the educational platform as the hub for quality assurance system of preclinical and clinical trials of drugs and vaccines in Russia in accordance with GLP, GCP and GMP standards.
The specialists from “TEMPO” members and in coordination with the leading international organization RAPS (Regulatory Affairs Professional Society) have developed the first in Russia educational program on drug preclinical studies in compliance with GLP international standards and requirements. RAPS aims to create and upholding standards of ethics, credentialing and education for the regulatory affairs profession within the health product sector, maintain informational support and education. In 2004 the specialists from Russia for the first time became RAPS members, and namely “TEMPO” specialists. Currently negotiations on creation of RAPS division in Russia on the base of “TEMPO” and under the close participation of “TEMPO” are being carried out as the follow-up of long-term collaboration between the Partnership and RAPS.
The curriculum of the education program on GLP was approved by the Educational-Methodical Association of Medical and Pharmaceutical Institutes that allowed issuing appropriate Russian state diplomas and state certificates to the successful trainees in accordance with established Russian legislation. To date 4 sessions were conducted, 130 specialists were trained. “TEMPO” educational program on preclinical trials was recognized by RAPS as the program that is in compliance with the international standards. The program is listed on http://www.raps.org/ among other international training programs on regulatory affairs that officially approved and conducted by RAPS.
Non Commercial Partnership “TEMPO” started to implement a new project in February 2006 that aims at development of educational programs in GMP area and audit of biopharmaceutical manufacture, as well as training of specialists working on production of drugs, vaccines and biologics. The Working Group, consisting “TEMPO” and the I.M. Sechenov Moscow Medical Academy experts, has developed two novel training programs for the general course “Organization, preparation, manufacturing, quality assurance of drugs in accordance with GMP requirements” and for the special course “Audit of drugs, biopharmaceuticals and biologically active compounds manufacturing”. The programs were approved by the Educational-Methodical Association of Medical and Pharmaceutical Institutes that allowed issuing appropriate Russian state diplomas and state certificates to the successful trainees in accordance with established Russian legislation. Gaining the experience of successful cooperation with RAPS on training of regular affairs specialists in GLP area, “TEMPO” specialists accomplished the revision of GMP educational programs according to the recommendations of RAPS experts. This enables to bring the developed programs into line with international educational standards in regulatory affairs area. RAPS experts took part in conducting training and developing of training materials, as well as in auditing of the courses. Nowadays 3 sessions of the general GMP course were performed and more than 110 specialists were trained (in Moscow, Puschino of Moscow Region and Novosibirsk Region for Vector's personnel), as well as the session for auditors in which 20 top managers of production facilities from “TEMPO” members attended. The one of a very important key point of GMP course, which is conducted by “TEMPO”, is practical training on the base of modern pharmaceutical factories, which operating in accordance with GMP standards (Research-and-Production Unit "PetrovaxPharm", Moscow, and "ABOLmed" Ltd Company in Novosibirsk). The practical training includes introductory presentation made by the company/the factory and GMP policy. A special interest was raised by the excursion at factory with visiting of restricted production (technical) areas, laboratories and storage facilities.
In addition to the regular training, “TEMPO” started to develop distance learning courses in the area of GXP based on elaborated education programs. Currently, interactive distance learning of “TEMPO” members specialists on the general GMP course, using modern Internet technologies, is performed. The tutors participate; training materials are used that allow trainees to get qualified education by self-learning.
Education system for preclinical studies in Russia according to GLP standards
Final report on the 1st stage of GLP Training Project's implementation