Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
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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2.
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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3.
Pashkov, V. M..
    The Directions of Development of Legal Regulation of Patenting the Methods of Treatment in Ukraine Considering the European and World Experience [Текст] / V. M. Pashkov, Y. A. Hrekov, M. M. Hrekova // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P. 628-632
   Перевод заглавия: Направления развития правового регулирования патентования методов лечения в Украине с учетом европейского и мирового опыта
УДК
ББК Р

Аннотация: INTRODUCTION: the current state of patenting legal regulation of medical treatment in Ukraine and in the world is analyzed, the directions for the further development are determined. The author defines "non-industrial medical" and socio-ethical theories in the field of medical treatment patent protection. The existence of exclusively formal "monopoly" of the patent owner is noted, as well as the inapplicability of the majority of the patented achievements in this field in Ukraine. AIM: the purpose of this article is to investigate the current state of patenting legal regulation of medical treatment in Ukraine and in the world, to analyze the limitation of patent protection basic conception in the medical field and to determine the tendencies and perspectives of the legal protection mechanism of further development in this field in Ukraine, considering the European and world regulation experience. MATERIAL AND METHODS: this study is based on Ukrainian regulation acts, The European Patent Convention, The Code of Laws of the United States of America, judgments, scientific works and opinions of progressive-minded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive are used in the article. CONCLUSION: The experience analysis of the medical treatment patenting regulation in EU and in other countries of the word made it possible to substantiate the tendencies of development the patenting legal regulation of treatment methods mechanism, based on the needs of creation conditions for the availability of the recent treatment developments and technics for citizens, without increasing the cost of such treatment through license fees.

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4.
Pashkov, V. M..
    3-D Bioprinting Law Regulation Perspectives [Текст] / V. M. Pashkov, A. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 3 pt 1. - p. 480-482
   Перевод заглавия: 3-D перспективы регулирования биопринтинга
УДК
ББК Х833

Аннотация: INTRODUCTION: Achieved level of technical progress moves us closer and closer to practical use of 3-d bioprinting technologies in real life. Such perspective raise a wide variety of crucial legal issues from the acceptable model of regulation of the science and its' societal effects to problems of the commercialization of the technology and potential restrictions of its use. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Scientific discussion on 3-D bioprinting, European Union`s and US experience in patenting of 3-D bioprinting technologies, European Medicine Agency (EMA) or the US Food and Drug Administration (FDA) regulations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: General debate of last few years comes down to an attempt to resolve hesitation between legal attempts for regulation of 3-D biobrinting and concept of complete prohibition of such activities. An adequate response to the mentioned challenge is a reasonable position between some aspects of prohibition and self-regulation, resulting in a moderate number of regulations and standards for developing and marketing. Such regulations may concern an intellectual property (IP) rights, regulation of distribution, premarket restrictions, control mechanism etc. CONCLUSION: Scientific approach and regulatory settlement of 3-D bioprinting sphere must unite to achieve a fair balance between the interests of humanity and of individuals - on the one hand, and development of science and business benefits for stakeholders - on the other. The main instruments for this must be balanced regulation of intellectual property (IP) rights, regulation of access and distribution, premarket restrictions, control mechanism etc.

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5.
Pashkov, V. M..
    Legal Regulation of the Production and Trade of Medical Devices and Medical Equipment in the EU and US: Experience for Ukraine [Текст] / V. M. Pashkov, А. Kotvitska, A. O. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P. 614-618
   Перевод заглавия: Правовое регулирование производства и торговли медицинскими приборами и медицинским оборудованием в ЕС и США: опыт для Украины
УДК
ББК Х623.211.84

Аннотация: INTRODUCTION: The need for effective legal regulation of production and sale of medical products in Ukraine due to its social effect is obvious and requires a high level of clarity. The experience of more advanced countries in this area, given the way chosen by Ukraine to harmonize our laws with EU legislation, is certainly could be a useful source of information. The urgency of issues need further intensification of national legal reforms. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Legislation of Ukraine, European Union, United States of America, Guidelines, developed by European Commission & Food and Drug Administration's (FDA), recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: This study provide a possibility to state that main difference of regulatory systems in EU and US is that the legal framework of the EU is more flexible. This flexibility is grounded on main principle that only basic quality requirements for medical devices is defined by legislative acts however more detailed requirements are defined in standards, technical regulations, specifications, which are discretionary in nature. Contractors are free to choose any technical solution that provides compliance with the essential requirements, they can choose among different conformity assessment procedures and between accredited conformity assessment bodies to which they want to apply. The contractors themselves is interested to pass the conformity assessment procedure and have the right to put a conformity mark on their medical device because it will give them a real competitive advantage. In contrast, US State regulatory system provides strict control over business entities and law act establishes the quality requirements of medical products. The only body that can authorize the introduction of medical products and perform post-market monitoring is Food and Drug Administration (FDA), which has almost unlimited competence in this sphere. CONCLUSION: Taking into account further deepening of the European integration process of Ukraine, establishing of the regulatory system as much similar to that of the EU as possible is a main goal of legal reforms in abovementioned sphere. On the one hand, such system allows to implement effective control of contractors in the sphere of production and sale of medical products and provide safety of medical devices that are introduced, on the other hand, it does not afflict contractors with excessive and total control, allowing them to choose behavior that is most acceptable, understandable and user-specific. However, US's experience also has some positive characteristics, which could be taken into account. Therefore, such complex symbiosis of approaches from our point of view will balance controversial interest of manufacturers, sellers and consumers of medical devices.

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6.
Pashkov, V. M..
    Enforceability of non-compete agreements in medical practice: between law and ethics [Текст] / V. M. Pashkov, A. O. Harkusha // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue: 12 cz 2. - P. 2421-2426
   Перевод заглавия: Возможность применения неконкурентных соглашений в медицинской практике: между законом и этикой.
УДК
ББК Х623.211.84
РУБ DOI: 10.36740/WLek201912205

Аннотация: OBJECTIVE: Introduction: The core of physician's non-compete agreements problematics lies in complex system of controversial interests, rights and goals of subjects involved. On the one hand non-compete restrictions and their enforceability is an obvious part of employer's legitimate business interest based on the freedom of contract, on the other - free unrestricted market, preventing of monopolization, availability of medical assistance and healthcare, right to choose a doctor are social standards and thus - a part of public interest, in addition to this - non-compete restrictions impact physician's right to work. Balance between these components is pretty sensitive and hard to achieve. We can find enforceability of physician's non-compete provisions in different types of relations: employment contracts, partnership agreements, sale of medical practice. But complexity of mixing law, ethical, social issues along with different approaches of legal regulations rises the relevance of research. PATIENTS AND METHODS: Material and methods: This study is based on German, British, Spain, Swiss, USA regulation acts, scientific researches and opinions of progressive-minded people in this sphere. The article is based on dialectical, comparative, analytic, synthetic and comprehensive methods. RESULTS: Results: Non-compete agreements may have social benefits in some situations: serve as an instrument to protect trade secrets thus stimulate innovation; reducing of worker's exit probability could increase quality of medical services due to training of employees etc. But also, there are some serious risks to employee, to employer and to society as a whole. Analyzing the sense of non-compete clause in general we can assume that it includes seven main points: the subject; the form; the time; the territory; the scope and type of restrictions; "buy out" of the clause and the compensation. These characteristics are the core of non-compete clause, and, taking into account the principle of freedom in terms of agreement conclusion, it is up to law enforcement practice to determine minimal and maximal limits of such restrictions. US legal concept is clearly based on implementing of legally prescribed restrictions for non-compete with physicians (along with other categories). European practice being pretty similar in view on what non-compete agreement is and what principles it is based on however is obviously different in approach chosen because of absence of special legal provisions for physicians' non-compete regulation. CONCLUSION: Conclusion: Lack of legal regulation and law enforcement practice in this sphere worldwide is obvious, so the starting point in resolving of physician's non-compete enforceability issue will be choosing of suitable concept. Analyzing of proposed concepts, we came to the conclusion that the most perspective will be an approach of specification and clarification of "reasonability" meaning in terms of evaluation physicians' non-compete agreement validity and their impact on public interest.

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7.
Pashkov, V. M..
    Right to child health in context of natural environmental security [Текст] / V. M. Pashkov, M. V. Trotska, O. S. Soloviov // Wiadomosci lekarskie. - 2019. - Vol. 3, Issue: 3. - P. 418-424
   Перевод заглавия: Право на здоровье детей в контексте естественной экологической безопасности
УДК
ББК Р + Ю665

Аннотация: OBJECTIVE: Introduction: From different points of view, health in general and child health, in particular, constitute the highest value which preserves a significant amount of resource potential. Child health is understood as his/her state consisting of a certain system of elements (physical, psychological, etc.) each of which, on the one hand, is characterized by its specificity, and on the other hand, is in a complementary relationship with each other. A process of child health formation is influenced by a large number of various elements (social, economic, etc.) and the natural environment is one of them. Its compliance with certain rules and standards that form its qualitative status affects life and health both directly and indirectly, therefore, determination of interdependence between the natural environmental conditions and child health is important for understanding a causal link between the specified categories. The aim: To study provisions of international acts and other sources in order to clarify the concept of child health and a role of the natural environment of a proper quality in the process of its formation. PATIENTS AND METHODS: Materials and methods: the paper examines provisions of international acts, some scientists' conclusions and other sources. Different authors' scientific viewpoints are studied with scientific methods in the context of medical and legal components. Within the framework of the system approach, as well as analysis and synthesis, the concepts of safe natural environment, health in general and child health, in particular, as well as importance of a safe natural environment for child health are researched. RESULTS: Review: The concept of health is complex and depends on various factors including proper natural environmental conditions. Presence of dangerous environmental factors affects occurrence of various children diseases. In the context of the natural environmental security, it is possible to indicate both general and individual natural resources. Their deterioration may affect its condition at large. CONCLUSION: Conclusions: Ensuring child health, his/her proper physical, psychological and other development is impossible without guaranteeing natural environmental security. Consumption of high-quality natural resources, observance of norms and standards for the environmental security allows the human body to develop fully accumulating relevant resources and attracting them at the right time. Ensuring the natural environment of a proper quality guarantees a greater range of opportunities for a child in the process of forming, coming into being and maintaining his/her physical and psychological well-being, which is a prerequisite for exercising his/her other rights and proper fulfillment of his/her duties in the process of his/her transformation and transition to adulthood.

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8.
Pashkov, V. M..
    Artificial intelligence in medical practice: regulative issues and perspectives [Текст] / V. M. Pashkov, A. O. Harkusha, Y. O. Harkusha // Wiadomosci lekarskie. - 2020. - Vol. 73, Iss. 12, cz. 2. - P. 2722-2727
   Перевод заглавия: Штучний інтелект у медичній практиці: регулятивні питання та перспективи
УДК
РУБ PubMed ID33611272 + DOI: 10.36740/WLek202012204

Аннотация: OBJECTIVE: The aim of the research is to identify specific of AI in healthcare, its nature, and specifics and to establish complexities of AI implementation in healthcare and to propose ways to eliminate them. PATIENTS AND METHODS: Materials and methods: This study was conducted during June-October of 2020. Through a broad literature review, analysis of EU, USA regulation acts, scientific researches and opinions of progressive-minded people in this sphere this paper provide a guide to understanding the essence of AI in healthcare and specifics of its regulation. It is based on dialectical, comparative, analytic, synthetic and comprehensive methods. RESULTS: Results: One of the first broad definitions of AI sounded like "Artificial Intelligence is the study of ideas which enable computers to do the things that make people seem intelligent ... The central goals of Artificial Intelligence are to make computers more useful and to understand the principles which make intelligence possible." There are two approaches to name this technology - "Artificial intelligence" and "Augmented Intelligence." We prefer to use a more common category of "Artificial intelligence" rather than "Augmented Intelligence" because the last one, from our point of view, leaves much space for "human supervision" meaning, and that will limit the sense of AI while it will undoubtedly develop in future. AI in current practice is interpreted in three forms, they are: AI as a simple electronic tool without any level of autonomy (like electronic assistant, "calculator"), AI as an entity with some level of autonomy, but under human control, and AI as an entity with broad autonomy, substituting human's activity wholly or partly, and we have to admit that the first one cannot be considered as AI at all in current conditions of science development. Description of AI often tends to operate with big technological products like DeepMind (by Google), Watson Health (by IBM), Healthcare's Edison (by General Electric), but in fact, a lot of smaller technologies also use AI in the healthcare field - smartphone applications, wearable health devices and other examples of the Internet of Things. At the current stage of development AI in medical practice is existing in three technical forms: software, hardware, and mixed forms using three main scientific-statistical approaches - flowchart method, database method, and decision-making method. All of them are useable, but they are differently suiting for AI implementation. The main issues of AI implementation in healthcare are connected with the nature of technology in itself, complexities of legal support in terms of safety and efficiency, privacy, ethical and liability concerns. CONCLUSION: Conclusion: The conducted analysis makes it possible to admit a number of pros and cons in the field of AI using in healthcare. Undoubtedly this is a promising area with a lot of gaps and grey zones to fill in. Furthermore, the main challenge is not on technology itself, which is rapidly growing, evolving, and uncovering new areas of its use, but rather on the legal framework that is clearly lacking appropriate regulations and some political, ethical, and financial transformations. Thus, the core questions regarding is this technology by its nature is suitable for healthcare at all? Is the current legislative framework looking appropriate to regulate AI in terms of safety, efficiency, premarket, and postmarked monitoring? How the model of liability with connection to AI technology using in healthcare should be constructed? How to ensure privacy without the restriction of AI technology use? Should intellectual privacy rights prevail over public health concerns? Many questions to address in order to move in line with technology development and to get the benefits of its practical implementation.

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9.
Pashkov, V. M..
    The theoretical and legal basis for environmental risk as a possible measurement of harm to the environment and human health [Текст] / V. M. Pashkov, M. V. Trotska, A. O. Harkusha // Wiadomosci lekarskie. - 2020. - Vol. 73, Iss.11. - P. 2523-2527
   Перевод заглавия: Теоретичні та правові основи екологічного ризику як можливого виміру шкоди для навколишнього середовища та здоров'я людини
УДК

Аннотация: OBJECTIVE: The aim: To inquire into a theoretical and legal basis that regulates relevant areas and processes; use of certain objects, associated with ecological risks, which association, in turn, indicates the likelihood of conditions that can have adverse effects on the environment, human life and well-being. PATIENTS AND METHODS: Materials and methods: In this work we study statutory regulations and scientific positions of scholars regarding the above-mentioned issue. The study analyses generalized information from scientific journals employing scientific methods from a medical and legal perspective. This article is based on dialectical, comparative, analytic, synthetic, and comprehensive research methods. CONCLUSION: Conclusions: The importance of the issue of environmental risks reflects the need in solving the problem of coexistence between human beings and nature. The analysis of theoretical and legal basis within the outlined framework will allow detecting the gaps and will help to understand in what way they are surmountable while regulating the stressors associated with ecological risks, on one hand, and, on another hand - the possible consequences, in order to prevent and eliminate them as promptly as possible and, thus, minimize their adverse effects on the environment and the health of the population.

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10.
Horodovenko, V. V..
    International legal instruments in the field of bioethics and their impact on protection of human rights [Text] / V. V. Horodovenko, V. M. Pashkov, L. G. Udovyka // Wiadomosci Lekarskie. - 2020. - Vol. 73, Iss. 7. - P. 1554-1560
   Перевод заглавия: Международно-правовые инструменты в области биоэтики и их влияние на защиту прав человека
ББК Х623.211.84
РУБ PubMed: 32759454

Аннотация: OBJECTIVE: Introduction: A rapid development of biomedicine, genetics, pharmacology, transplantation and biotechnology has posed a number of problems to humanity, in particular, with regard to human rights protection in healthcare. These problems solution requires considering the achievements and propositions of biology, medicine, ethics and law. International legal standards in the field of bioethics are of significance in development of national states regulations on bioethics and biotic legislation. Aim: To investigate the impact of international legal instruments in the field of bioethics on protection of human rights. PATIENTS AND METHODS: Materials and methods: In the research the international legal instruments and documents in the field of healthcare and bioethics were used. Civilizational, axiological, dialectical, systemic and comparative legal methods as well as systematization, analysis and synthesis were decisive in the research process. CONCLUSION: Conclusions: Legal instruments in the field of biomedical technologies (directives and regulations) are mainly advisory by nature. In many cases, the problems arising in biotechnology are resolved through establishment and involvement of national supervision bodies: councils (commissions, committees) in bioethics as well as courts. An important role in protection of human rights in the field of biotechnology is played by the ECHR the decisions of which are dynamic, based on the Convention and consideration of national legislations. At the same time, a number of problems remain unresolved because of constant development of biomedical technologies, necessity to take into account the latest achievements and discoveries as well as all types and methods of applying of genetic engineering to humans. In general, insufficient attention is paid to the problems of medical biotechnologies application both at the international and national levels.

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