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Russia plans to launch the first professional training program for EAEU GLP inspectors

The Eurasian Academy of Good Practices, which was opened at the Chamber of Commerce and Industry of the Russian Federation on April 22, will create an integrated approach to the creation of effective and safe medicines. It is based on training professionals in the fields of all good pharmaceutical practices (GxP): GLP, GCP, GMP, GDP, GSP, GvP and others, according to the State Institute of Medicines and Good Practices.

As part of the implementation of this approach, the SILS and NP, together with the Peoples' Friendship University of Russia, the Eurasian Academy of Good Practices and leading experts in the field of good pharmaceutical practices, developed a professional retraining program (DPO) “training of an inspector / auditor to assess the compliance of testing laboratories (centers) with the requirements of the rules of proper laboratory practice (GLP) ". The program is designed for specialists in the inspection and audit of testing laboratories conducting preclinical (non-clinical) laboratory studies of drugs and is the first educational product of this format and scale.

Compliance with GLP requirements is the foundation of international trust in pharmaceuticals. The effectiveness of a GLP regulatory system depends on a number of factors. The key factors are: clarity and consistency of regulatory documents, harmonization of requirements, a mechanism for monitoring compliance with GLP requirements (single inspectorate), as well as the level of competence and professionalism of experts, auditors and inspectors.

The course in the amount of 260 academic hours has already been approved by the RUDN University. The theoretical part of the program is 180 hours and is presented by the most relevant materials on the legal regulation of GLP in Russia, the EAEU and the OECD, requirements for pre-registration non-clinical studies, GLP rules and their application, methodology of various types of GLP studies, issues of ensuring data integrity and computer security, as well as detailed materials on the procedure for conducting inspections (audits) of testing laboratories for compliance with GLP requirements (regulatory legal acts of the Russian Federation, regulatory documents of the EAEU, OECD and EU. Main detected violations).

An additional fragment of the theoretical course is a module on the bioanalytical part of bioequivalence studies.

The practical part of the program is 80 academic hours, it is developed on the basis of world experience in the field of assessing compliance with GLP requirements and is fully devoted to the organization of inspection (audit) of testing laboratories for compliance with GLP requirements.

As a result, students receive a RUDN University diploma on professional retraining of the established sample (diploma in Russian and English). The start of training for this program is tentatively scheduled for June 2021.

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