Open AccessRisk Management in Preclinical Trials as Part of an Overall Integrated Quality Management System
Author(s) -
М. А. Зайцева,
М. Б. Иванов,
А. Б. Верведа,
Л. В. Лянгинен
Publication year - 2020
Publication title -
bezopasnostʹ i risk farmakoterapii
Language(s) - English
Resource type - Journals
eISSN - 2619-1164
pISSN - 2312-7821
DOI - 10.30895/2312-7821-2020-8-1-36-42
Subject(s) - risk management , risk analysis (engineering) , preparedness , documentation , quality management system , quality (philosophy) , process management , audit , process (computing) , quality assurance , management system , quality management , operations management , medicine , engineering , computer science , business , external quality assessment , philosophy , accounting , finance , epistemology , political science , law , programming language , operating system
The implementation of a complex risk-oriented approach at all stages of drug development, including the preclinical research stage, is essential for ensuring drug safety, quality and effi cacy. The aim of the study was to justify the benets of introducing risk management into the integrated quality management system at the preclinical trial stage. The optimal approach to implementing risk management system at the preclinical stage is an overall process approach based on the international standard ISO 31000:2009 Risk management—Principles and guidelines. This approach as applied to a preclinical research centre includes a three-tier risk management system at the level of operational process subsystems, the level of the testing centre’s departments, and the level of an individual preclinical study. The common components of the subsystems may include concepts, organisational structure, information exchange system, documentation structure, etc. The process of risk management as applied to the subsystems includes risk identication, analysis, assessment, and response to the risk. The response to the risk is an iterative process that includes selection of response options, response planning, and implementation of response activities from control procedures to corrective and preventive actions. The integration of the preclinical risk management system into the organisation’s overall management system, which includes the occupational health and safety management system and the quality management system, will enhance the capabilities of the individual systems to achieve a high quality level of research, preserve the sta ’s professional health, make informed management decisions within the organisation, increase preparedness for external audits, and gain competitive advantages.