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The aim: To review real-life regulatory-dependent study design and data management practices of post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and Poland. Materials and methods: This article presents the case study of 4 post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and European Union. Results: The case study presented effective cross-border cooperation between Ukrainian and European actors. Despite the gaps in Ukrainian legislative framework on medical devices, complex solutions on employment of the most stringent regulatory provisions led to appropriate study design. Usage of the highly compliant electronic data capture led to fast-track study start-up and solid clinical data collection. Conclusions: Publications on real-life regulatory-dependent clinical trials conduct might be essential to innovate the regulatory system in Ukraine. The cross-border cooperation might assist the advancement of clinical trials industry in Ukraine. Gaps in medical devices regulations in Ukraine impede the context-specific clinical trials solutions for biotech industry in Ukraine. The regulatory framework and practice in Ukraine may be perceived as externally driven due to gaps in medical devices regulations, lack of capacities of domestic notified bodies and business interests of Sponsors.

Objective The aim: The identification and determination of needs that the population of older age groups have in medical and social services on the basis of health data and the results of a survey. Patients and methods Material and methods: Because of bibliographic, epidemiological, medical-statistical, analytical methods the research has investigated the problems of healthy aging, tendencies in population health of the population of Ukraine of senior age groups during 2000-2017, features and tendencies of health of a sample contingent of urban population of elderly age according to appeals in health care facilities during 2009-2019. The use of the sociological method, the self-evaluation of elderly people of their own health, characteristics of lifestyle and medical activity are determined, the needs of older people in medical and social services were assessed. Results Results: Negative tendencies to increase during 2000-2017 the prevalence of pathology among the population older than working age by 22.8%, including blood diseases in 2 times, endocrine system - in 1.8 times, urogenital system - by 1.5 times, digestive organs - by 1.4 times, tumors and nervous system - by 1.3 times. Among the urban elderly population, the prevalence of sensory diseases, including ear and eye diseases, endocrine disorders, injuries and poisonings, has increased, and mental health indicators have deteriorated. The sociological survey found a low level of self-esteem (31.5±3.5 per 100 had health problems, 10.1±2.3 are significant). Self-medication was practiced by 76.4±3.2 per 100 respondents, 74.2±3.3 were not followed or they violated the doctor's recommendations. 56.2 ±3.7 per 100 respondents had physical examinations in the non-right time 29.7±3.4 had not it.There was a significant prevalence of risk factors, including hypodynamics (21.9±3.1 per 100), tobacco use (29.8±3.4), malnutrition (37.1±3.6), overweight (obesity) (32, 6±3.5), arterial hypertension (37.6±3.6), hypercholesterolemia (28.7±3.4), glucosemia 16.3±2.8). The research has discovered the needs of older people in health care and social services, inter alia in preventive counseling (65.2±3.6 per 100), the introduction of electronic technologies in health care (68.5±3.5), information educational services on health issues (67.4±3.5), provision of services in hospitals at home (66.3±3.5), in increasing the availability of rehabilitation (43.8±3.7), specialized counseling (34.3±3.6) and emergency medical care (16.2±2.8), improvement of socio-economic determinants (78.0±3.1), introduction of activities (48.3±3.7), joint training programs for older people (42.1±3.7), the development of certain skills, the use of technical means, assistive devices (67.4±3.5), the formation of a conducive to better health environment (58, 4±3.7). Conclusion Conclusions: The low level of the elderly people's health, the tendency to increase the burden of disease, the prevalence of risk factors for disease and low medical activity lead tosignificant needs for medical and social services of preventive, treatment-diagnostic, rehabilitation, improving socio-economic determinants, measures to reduce social isolation.

The aim: The identification and determination of needs that the population of older age groups have in medical and social services on the basis of health data and the results of a survey.Material and methods: Because of bibliographic, epidemiological, medical-statistical, analytical methods the research has investigated the problems of healthy aging, tendencies in population health of the population of Ukraine of senior age groups during 2000-2017, features and tendencies of health of a sample contingent of urban population of elderly age according to appeals in health care facilities during 2009-2019. The use of the sociological method, the self-evaluation of elderly people of their own health, characteristics of lifestyle and medical activity are determined, the needs of older people in medical and social services were assessed.Results: Negative tendencies to increase during 2000-2017 the prevalence of pathology among the population older than working age by 22.8%, including blood diseases in 2 times, endocrine system - in 1.8 times, urogenital system - by 1.5 times, digestive organs - by 1.4 times, tumors and nervous system - by 1.3 times. Among the urban elderly population, the prevalence of sensory diseases, including ear and eye diseases, endocrine disorders, injuries and poisonings, has increased, and mental health indicators have deteriorated. The sociological survey found a low level of self-esteem (31.5±3.5 per 100 had health problems, 10.1±2.3 are significant). Self-medication was practiced by 76.4±3.2 per 100 respondents, 74.2±3.3 were not followed or they violated the doctor's recommendations. 56.2 ±3.7 per 100 respondents had physical examinations in the non-right time 29.7±3.4 had not it.There was a significant prevalence of risk factors, including hypodynamics (21.9±3.1 per 100), tobacco use (29.8±3.4), malnutrition (37.1±3.6), overweight (obesity) (32, 6±3.5), arterial hypertension (37.6±3.6), hypercholesterolemia (28.7±3.4), glucosemia 16.3±2.8). The research has discovered the needs of older people in health care and social services, inter alia in preventive counseling (65.2±3.6 per 100), the introduction of electronic technologies in health care (68.5±3.5), information educational services on health issues (67.4±3.5), provision of services in hospitals at home (66.3±3.5), in increasing the availability of rehabilitation (43.8±3.7), specialized counseling (34.3±3.6) and emergency medical care (16.2±2.8), improvement of socio-economic determinants (78.0±3.1), introduction of activities (48.3±3.7), joint training programs for older people (42.1±3.7), the development of certain skills, the use of technical means, assistive devices (67.4±3.5), the formation of a conducive to better health environment (58, 4±3.7).Conclusions: The low level of the elderly people's health, the tendency to increase the burden of disease, the prevalence of risk factors for disease and low medical activity lead tosignificant needs for medical and social services of preventive, treatment-diagnostic, rehabilitation, improving socio-economic determinants, measures to reduce social isolation.