Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
Pashkov, V. .
    Certain aspects on medical devices software law regulation [Текст] / V. Pashkov, A. Harkusha // Wiadomości Lekarskie. - 2016. - Vol. LXIX = Tom LXIX, nr 6. - S. 765-767
УДК
ББК Р

Аннотация: INTRODUCTION: some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

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2.
Pashkov, V. .
    Medical device software: defining key term [Текст] / V. Pashkov, N. Gutorova, A. Harkusha // Wiadomości Lekarskie. - 2016. - Tom LXIX, nr 6. - P. 813-817
   Перевод заглавия: Медицинское программное обеспечение устройства: определение ключевых терминов.
УДК
ББК Р

Аннотация: INTRODUCTION: one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

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3.
Pashkov, V. M..
    The impact of the legal regime of intellectual property protection in the pharmaceutical market [Текст] / V. M. Pashkov, І. A. Golovanova, A. Olefir // Wiadomości Lekarskie. - 2016. - Vol. LXIX = Тom LXIX, nr 3, cz. II. - S. 582 - 586
   Перевод заглавия: Влияние правового режима охраны интеллектуальной собственности на фармацевтическом рынке
УДК
ББК Р45

Аннотация: INTRODUCTION: the functioning of the healthcare industry in any country is impossible without providing enough medicines for patient care. This problem can best be resolved only when the majority of drugs, especially vital, will be made at national plants (industry). In this context, competition from generic drugs is the most optimal strategy to reduce drug's prices. AIM: the paper should examine how the legal regime of intellectual property affects the availability of medicines for people and identify ways of supporting breakthrough inventions and counter ≪unreal innovations≫. MATERIALS AND METHODS: for the purpose of study were generalized information from the scientific journals of medical and legal perspective, monographs by using a set of scientific methods. Namely under systematic approach have been analyzed the problems of pharmaceutical market, ways of producing generic and original drugs. Comparative legal method was useful for learning features of flexible mechanisms of the TRIPS Agreement and market regulation of medicines in the world. RESULTS: based on the research was found that developed countries with strong pharmaceutical industry are interested in maximizing the protection of intellectual property rights, including importing countries. Flexible mechanisms of the TRIPS Agreement can be useful for developing countries. CONCLUSIONS: thus, successful development of pharmaceutical industry and health care should be accompanied by the following measures: - improvement of public health must be recognized as a main task of government policy; - substantial state support aimed at increasing the availability of drugs in the domestic market and the strengthening of export potential; - decrease patent protection of medicines and stimulate market launch of generic copies.
Вступ: функціонування галузі охорони здоров'я в будь-якій країні неможливе без забезпечення пацієнтів ліками у достатній мірі. Ця проблема може бути вирішена тільки тоді, коли більшість ліків, особливо життєво важливих, вироблятимуться у національній промисловості. У зв'язку з цим, конкуренція з боку універсальних препаратів є найбільш оптимальною стратегією зниження цін на ліки. Мета: розглянути як правовий режим інтелектуальної власності негативно позначається на доступності лікарських засобів для населення та визначити шляхи підтримки проривних винаходів та «нереальних інновацій». Матеріали і методи: для цілей дослідження були узагальнені відомості з наукових журналів, медичної та юридичної точки зору, монографій, використовуючи набір наукових методів. Саме в рамках системного підходу проаналізовано проблеми фармацевтичного ринку, способи виробництва універсальних і оригінальних препаратів. Порівняльно-правовий метод був корисний для вивчення особливостей гнучких механізмів Угоди ТРІПС та регулювання ринку лікарських засобів у світі. Результати: на підставі досліджень було встановлено, що розвинені країни з потужною фармацевтичною промисловістю, зацікавлені в максимізації захисту прав інтелектуальної власності, в тому числі країн-імпортерів. Гнучкі механізми Угоди ТРІПС можуть бути корисні для країн, що розвиваються. Висновки: таким чином, для успішного розвитку фармацевтичної галузі і охорони здоров’я повинні бути забезпечені наступні заходи: - поліпшення здоров’я населення має бути визнано в якості основних завдань державної політики; - суттєва державна підтримка, спрямована на підвищення доступності ліків на вітчизняному ринку і зміцнення експортного потенціалу; - зниження патентної охорони лікарських засобів і виведення на ринок універсальних препаратів.

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4.
Pashkov, V. M..
    Principle of serviceability and gratuitousness in transplantation? [Текст] / V. M. Pashkov, I. A. Golovanova, P. P. Noha // Wiadomości Lekarskie. - 2016. - Vol. LXIX = Tom LXIX. nr 3. cz. II. - S. 565 - 568
   Перевод заглавия: Принцип платности и безвозмездности при трансплантации?
УДК
ББК Р45

Аннотация: INTRODUCTION: the issue of commercialization of transplantation analyses in the article. Attention is paid to the importance of transplantation as a method of treatment and saving human lives. AIM: the clarify the feasibility of the introduction of donation commercialization as an avenue to solve the shortage of donor organs and means of combating with black organ market and finding alternative avenues solving these problems, which are more morally acceptable for society is the aim of this article. MATERIALS AND METHODS: the experience of foreign countries has been analyses in the research. Additionally, we used data from international organizations, conclusions scientists and report of Global Financial Integrity in the research. RESULTS: it is impossible to solve most problems by means of paid donation. CONCLUSIONS: therapeutic organ and tissue cloning based on genetic technology is the best way out and solving ethical transplantation problems.
The impact of the legal regime of intellectual property protection in the pharmaceutical marketВступ: в статті аналізується питання про комерціалізацію трансплантації. Увагу приділено важливості трансплантації як методу лікування і порятунку людських життів. Мета: уточнити доцільність введення комерціалізації донорства як шлях для вирішення проблеми дефіциту донорських органів і способи боротьби з чорним ринком органів та знаходження альтернативних шляхів вирішення цих проблем, які є більш морально прийнятними для суспільства. Матеріали і методи: в дослідженні аналізується досвід зарубіжних країн. Крім того, в дослідженні використовувалися дані міжнародних організацій, висновки вчених і доповідь Global Financial Integrity. Результати: неможливо вирішити більшість проблем за допомогою платного донорства. Висновки: терапевтичне клонування органів і тканин на основі генної технології - це кращий вихід із ситуації і вирішення етичних проблем трансплантології.

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5.
Pashkov, V. M..
    International Legal Regulation of Impact of Occupational Injuries and Diseases on Agricultural Workers' Health [Текст] / V. M. Pashkov, O. M. Batyhina, M. V. Trotska // Wiadomosci lekarskie. - 2017. - Vol. 70, No. 5. - P. 953-958
   Перевод заглавия: Международное правовое регулирование воздействия профессиональных травм и болезней на здоровье сельскохозяйственных работников
УДК
ББК Х627.4

Аннотация: INTRODUCTION: Agricultural workers' health depends on many factors: working conditions, security arrangements, medicine, quality of drugs, the environment, etc. Occupational injuries and diseases are also among the factors that can negatively affect their health. THE AIM: To analyze provisions of the international legislation and scientific literature concerning existence of restrictions on impact of occupational injuries and diseases on agricultural workers' health. MATERIALS AND METHODS: International acts, data of international organizations and conclusions of scientists have been examined and used in the study. The article also integrates information from scientific journals and monographs from a medical and legal point of view with scientific methods. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. Impact of occupational injuries and diseases on agricultural workers' health has been studied within the system approach, as well as analysis and synthesis. CONCLUSIONS: The level of occupational morbidity, traumatism and above all standard of agricultural workers' health depends on the way of occupational safety organization. Working conditions and safety in agricultural industry and therefore the appropriate standard of health remain unsatisfactory in many countries.

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6.
Pashkov, V. M..
    Legal Aspects of Counteracting the Trafficking of Falsified Medicines in the European Union [Текст] / V. M. Pashkov, A. Soloviov, A. A. Olefir // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:4. - P. 843-849
   Перевод заглавия: Правовые аспекты противодействия торговле фальсифицированными лекарствами в Европейском союзе
УДК
ББК Х623.211.84

Аннотация: INTRODUCTION: The paper identifies key risks associated with the illegal production and sale of medicines. Also there were generalized features of criminal responsibility for acts related to the trafficking of drugs in some Member States of the EU and analyzed legal means of combating the falsified drugs today. The problem concerning falsification of medicines is particularly acute not only in developing countries but also in developed ones. Fake is one in ten - twenty drug. The largest share of falsified drugs comes from the so-called «Asian tigers», already from which they come to the EU market. THE AIM: In this publication authors have set following objectives: - to determine the risks associated with illegal production and sale of medicines; - organize legal means of combating the falsified medicines in the EU member states; - clarify features of criminal responsibility for acts related to the trafficking of drugs in the EU countries. MATERIALS AND METHODS: The article bases on the works of scholars and experts, statistical information and other sources. Particular attention is paid to the analysis of regulations of the EU institutions and national criminal laws. So, provisions of the criminal codes of 10 EU member states were taken into account. RESULTS: There is a system of legal measures which counter the circulation of falsified medicines in the EU and consists of general and specific regulatory requirements, mainly of economic and legal nature. The most important role among the last play package labeling requirements for drugs and license conditions. DISCUSSION: In the article were discussed factors that stimulate the production and sale of falsified drugs and the risks associated with these. Demarcated the concept of «falsified medicinal product», «counterfeit drug», «substandard drug». CONCLUSIONS: Although there are guidelines for patients to identify falsified drugs, still a major role in this process should play public authorities and enterprises. In all the countries illegal circulation of falsified drugs is prohibited under threat of criminal or administrative responsibility.

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7.
Pashkov, V. M..
    Legal Restraints of Pesticide Effect on Human Organism and Environment Under International Legislation [Текст] / V. M. Pashkov, O. Batyhina, M. Trotska // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:2 pt 2. - P. 366-371
   Перевод заглавия: Юридические ограничения воздействия пестицидов на организм человека и окружающую среду в соответствии с международным законодательством
ББК Р

Аннотация: ВВЕДЕНИЕ: Здоровье человека зависит от многих факторов: уровня медицины, качества медицинских препаратов, состояния окружающей среды, безопасности пищевых продуктов, образа жизни и других. Одним из факторов, которые могут оказать неблагоприятное воздействие на здоровье человека, являются фитосанитарные продукты, в том числе пестициды, используемые фермерами для уничтожения, контроля за воспроизводством и предотвращения вредных для животных, микробных или растительных вредителей при выращивании сельскохозяйственной продукции, которые являются основой человеческой пищи. AIM: Проанализировать положения международного законодательства о наличии эффективных средств предотвращения негативного воздействия пестицидов на здоровье человека и окружающую среду. МАТЕРИАЛЫ И МЕТОДЫ: В исследовании были изучены и использованы международные акты, данные международных организаций и выводы ученых. В статье также обобщается информация из научных журналов и монографий с медицинской и юридической точек зрения с использованием научных методов. В рамках систематического подхода анализируются вопросы воздействия пестицидов в процессе их использования на здоровье человека и окружающую среду. РЕЗУЛЬТАТЫ: На основе проведенного исследования было установлено, что развитые страны уделяют гораздо больше внимания профилактике и уменьшению негативного воздействия пестицидов на здоровье человека и окружающую среду в процессе их использования, чем развивающиеся страны. ВЫВОДЫ: Эффект пестицидов имеет двойственный характер. С одной стороны, позитивно обеспечить эффективное развитие сельского хозяйства, но, с другой стороны, негативно это выражается в потенциальных возможностях нанесения вреда людям и окружающей среде.

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8.
Tatsiy, V.
    Legal aspects of cancer deseases prophylactics: patients rights context [Текст] / V. Tatsiy, N. Gutorova, V. Pashkov // Wiadomosci lekarskie. - 2017. - Vol. 70. Issue: 6 pt 1. - p. 1108-1113
   Перевод заглавия: Правовые аспекты профилактики рака: профилактика заболеваний
ББК Р56
РУБ PubMed: 29478987

Аннотация: OBJECTIVE: Introduction: In accordance with Resolution on Cancer Control WHA58.22 Cancer prevention and control The Fifty-eighth World Health Assembly it is obvious technology for diagnosis and treatment of cancer is mature, and that many cases of cancer may be cured, especially if detected earlier Some key points on concept of legal regulation of abovementioned sphere is a base of this study. However, the problems of using an effective mechanism for protecting the rights of patients in certain types of disease, in particular cancer patients, by providing early diagnosis, are not fully developed by medical law specialists. The aim of the article is to determine the means of ensuring the right to health and life of cancer patients in particular through early diagnosis. PATIENTS AND METHODS: Material and Methods: This study is based on regulation acts, World health report (2013), The Fifty-eighth World Health Assembly, WHA58.22 Cancer prevention and control, Universal Declaration of Human Rights, International Covenant on Civil and Political Rights, International Covenant on Economic, Social and Cultural Rights, European Convention for the Protection of Human Rights and Fundamental Freedoms, Charter of Fundamental Rights of the European Union, research papers and views of progressive-minded people in this sphere. Article is grounded on dialectical, comparative, analytic, synthetic and comprehensive research methods. RESULTS: Review: Most countries have declared a compliance of their national legislation with international standards regarding the right to life and health. The analysis of the abovementioned international acts in context of protection of the rights of patients with cancer leads to the conclusion that countries that have undertaken international legal obligations to protect the right to life are required to take the necessary measures to ensure the effective treatment of cancer patients. Taking into account that the lack of such treatment due to the specificity of the disease entails the death of the patient, the state inaction in this area should be regarded as a violation of a human right for life. Absence of state's policy in terms of early detection of cancer brings a huge problem of human rights violation and providing the standards of fundamentally different approach of the European Union countries could become a great solution. CONCLUSION: Conclusions: Individual states do not pay sufficient attention to the need of effective public health policy. In today's world, there are objective prerequisites for changing the system of protection of patients' rights and, consequently, for changing views on health protection in general, especially in the part of functioning of diagnostic procedures system. Formation of a state policy on ensuring the rights of citizens to health and life, taking into account the various consequences of such a policy, cannot be narrowed down only to the proclamation of such rights, but also requires planning and development of relevant state programs. Failure by the state to provide the proper organization of health care through the establishment of early diagnosis for cancer patients, considering wide incidence and mortal danger of cancer in case of late diagnosis, should be considered as a violation of human rights. It also does not conform to ECHR practice in terms of provisions of Articles 2, 3 and 8 of European Convention.

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9.
Pashkov, V. .
    Protection of children’s rights in the health care: problems and legal issues [Текст] / V. Pashkov, A. Olefir // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 6 pt 1. - p. 1122-1132
   Перевод заглавия: Защита прав человека в здравоохранении: проблемы и юридические вопросы
ББК Р73

Аннотация: Introduction: Among all categories of patients children (minors) must be protected first. It is caused so by the specificity of the treatment, their vulnerability, the need of further protection and supervision. Providing of medical care services for children are often connected with the risks of the process of treatment, and of the drug usage. The aim: To identify the problems associated with the protection of the rights of minors and, on the basis of this, the basic guarantees of their rights, as well as mark the trends in the practice of ECHR. Materials and Methods: The study is based on its own theoretical and empirical basis. The theoretical basis include scientific articles, expert reviews of legislation and communications of non-governmental organisations, and empirical – decisions of the ECHR, international legal acts and directives of the EU. Results: The main violations of the rights of minor children include the following: – legal representatives of children do not take to the account their interests (refusal of medical intervention or the choice of certain method of interference); – medical intervention under the influence of coercion; – providing of unwarranted medical care without the corresponding testimony; – providing of inadequate medical care: when the patient was only examined and ineffective treatment was prescribed, and others. As for mentally ill children, the following rights are usually violated: for life, for a fair trial. It has been proved that defects in the provision of health care are often predetermined by the poor state logistics of hospitals, lack of financing and appropriate pediatric medicines, outdated methods of treatment, and incompetence of some doctors. Conclusions: From the point of view of protecting the rights of minors, the rights of children in medicine can be classified into universal and special. The rights correspond not only to the corresponding duties of medical staff, but also of their parents (legal representatives). Violations of their rights are usually related to improper representation of the interests of children and disadvantages of providing medical services (defects in their provision), in particular, regarding the treatment of mentally ill, as well as in clinical trials. It has been proven that the practice of the ECHR on the protection of the rights of the child in the field of health is of particular importance.

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10.
Pashkov, V. M..
    Concept of Waste and its Impact on Human Health [Текст] / V. M. Pashkov, O. M. Batyhina, M. V. Trotska // Wiadomosci lekarskie. - 2017. - Vol. 70, No. 5. - P. 964-969
   Перевод заглавия: Концепция отходов и их влияние на здоровье человека
УДК
ББК Х625.80

Аннотация: INTRODUCTION: Impact of the environment on human health is increasingly being paid attention both at the international level and at the level of individual countries. Among the factors that anyhow can affect it negatively, various objects are distinguished and waste is not of the last consequence. It has different nature of origin, ways of further utilization and a degree of impact on human health and the environment. Its generation, utilization and neutralization are determined by the relevant processes; their research allows continuous improvement and reduction of their negative impact on human health and the environment. THE AIM: To analyze provisions of the international legislation concerning the concept of waste and its classification, as well as its potential impacts on human health and the environment. MATERIALS AND METHODS: The study analyzes and uses international legal documents, data of international organizations and scientists' deductions. Furthermore, the study integrates information from scientific journals with scientific methods from the medical and legal point of view. Within the framework of the system approach, as well as analysis and synthesis, the concept of waste, its classification and impact on human health and the environment have been researched. RESULTS: In consequence of the conducted study, it has been found that at the European level, considerable attention is paid to waste in the context of its possible negative impact on human health and the environment. Solution of this problem is carried out with the integrated approach, which is expressed both in enacting statutory acts and amending existing ones, as well as elucidating various aspects at the scientific, methodological, statistical and other levels. CONCLUSIONS: Waste in itself has different nature of origin, negative impact, ways of its further utilization. Some kinds of it can be used further in order to achieve other goals and needs that are not related to their generation, others can no longer be used for human benefits taking into account existing achievements.

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