Risk management for quality assurance of preclinical research

Abstract

The article discusses various aspects of risk management for quality assurance (QA) of preclinical studies of drugs. The authors analysed risk management methods and approaches, and defined relevant risk management methods to be used in preclinical studies performed according to ISO 9001 and the Good Laboratory Practice principles. The article highlights the need for holistic risk management to ensure the reliability and safety of further preclinical research. The selection of a risk assessment method should be based on the analysis of the preclinical organization’s needs. The risk management activities should result in a system of corrective and preventive actions which aim to reduce risks and to assure regular monitoring.

Keywords

• управление рисками
• доклинические исследования
• система управления рисками
• методы оценки рисков
• обеспечение качества
• risk management
• preclinical research
• risk management system
• methods of risk assessment
• quality assurance