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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 benefits 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 identification, 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 staff ’s professional health, make informed management decisions within the organisation, increase preparedness for external audits, and gain competitive advantages.

The article discusses the impact of information on the risks in the workplace employees and workers, the safety of the labor process. The issues of determining the information, the impact of information on human emotions, calculations of risks and implementation of international standards, including ISO 31000, at Ukrainian enterprises. Touched on the certification of jobs on the risks and accounting risks. Consider proposals for the selection of methods of calculating risks. In OSH management system can be a few situations that determine there is a danger in the workplace, as the impact of information: lack of, incomplete and false (incorrect) information. Information supplied to the employee on different channels from different sources. Receives information through a conductor, in which can be a master site foreman, engineer and other members of the labor process, including work colleagues. From the "quality" of the conductor and his authority, for the employee depends on the perception of information and the results of the labor process, including the state of labor protection. Analyzing the above mentioned materials, note that in the present time, the infusion should: focus on the design and choice of method for workplace risk businesses and institutions of any form of property; solved at the state level, the question of the introduction of the recommended methods for calculating risks in enterprises and validation of the risks of all jobs, with the obligatory indication of the degree of risk in hiring; determine the degree of responsibility of business leaders for risk management and the development of programs and plans to reduce risks to acceptable levels., В статье рассмотрены вопросы влияния представления информации о рисках на рабочих местах служащих и работников, на безопасность процесса труда. Затронуты вопросы определения информации, влияние информации на эмоции человека, расчёты рисков и внедрение международных стандартов, в том числе ISO 31000, на предприятиях Украины. Затронуты вопросы проведения аттестации рабочих мест по рискам и учёта рисков. Рассмотрены предложения по выбору методики расчёта рисков., У статті розглянуті питання впливу подання інформації про ризики на робочих місцях службовців і працівників, на безпеку процесу праці. Порушені питання визначення інформації, вплив інформації на емоції людини, розрахунки ризиків та впровадження міжнародних стандартів, у тому числі ISO 31000, на підприємствах України. Порушені питання проведення атестації робочих місць за ризиками та обліку ризиків. Розглянуто пропозиції щодо вибору методики розрахунку ризиків.

В статье рассмотрены вопросы влияния представления информации о рисках на рабочих местах служащих и работников, на безопасность процесса труда. Затронуты вопросы определения информации, влияние информации на эмоции человека, расчёты рисков и внедрение международных стандартов, в том числе ISO 31000, на предприятиях Украины. Затронуты вопросы проведения аттестации рабочих мест по рискам и учёта рисков. Рассмотрены предложения по выбору методики расчёта рисков. The article discusses the impact of information on the risks in the workplace employees and workers, the safety of the labor process. The issues of determining the information, the impact of information on human emotions, calculations of risks and implementation of international standards, including ISO 31000, at Ukrainian enterprises. Touched on the certification of jobs on the risks and accounting risks. Consider proposals for the selection of methods of calculating risks. In OSH management system can be a few situations that determine there is a danger in the workplace, as the impact of information: lack of, incomplete and false (incorrect) information. Information supplied to the employee on different channels from different sources. Receives information through a conductor, in which can be a master site foreman, engineer and other members of the labor process, including work colleagues. From the "quality" of the conductor and his authority, for the employee depends on the perception of information and the results of the labor process, including the state of labor protection. Analyzing the above mentioned materials, note that in the present time, the infusion should: focus on the design and choice of method for workplace risk businesses and institutions of any form of property; solved at the state level, the question of the introduction of the recommended methods for calculating risks in enterprises and validation of the risks of all jobs, with the obligatory indication of the degree of risk in hiring; determine the degree of responsibility of business leaders for risk management and the development of programs and plans to reduce risks to acceptable levels.