Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
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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2.
Derevyanko, B. V.
    Addressing the issue of corporate raiding in Ukraine [Текст] / B. V. Derevyanko, V. M. Pashkov, O. A. Turkot, N. V. Zahrishev, O. S. Bisiuk // Problems and Perspectives in Management. - 2020. - Vol. 18, Issue 1. - P. 171-180
   Перевод заглавия: Решение проблемы корпоративного рейдерства в Украине.
УДК
РУБ http://dx.doi.org/10.21511/ppm.18(1).2020.15

Аннотация: The phenomenon of “raiding,” i.e., the unlawful establishment of control over the property or governing boards of an enterprise, as well as the seizure of its shares, has been reported in all countries of the world for many decades. This phenomenon has the most dangerous forms in the states with the underdeveloped economy and legal system, particularly in Ukraine. The paper aims to determine the areas for counteracting and overcoming corporate raiding in Ukraine and to provide proposals for improving the legislative framework for reliable protection against attacks on the enterprises’ property. The information in the paper, including the geography of raider attacks, indicates a greater vulnerability of enterprises in the most economically developed regions, with extensive transport infrastructure and the prospects for various industries and sectors of the economy development. The state should take some steps to increase the level of enterprises protection against raider attacks. Thus, to improve the quality of preventing and combating corporate raiding, this paper argues the need to develop and adopt the Corporate Property Protection Code of Ukraine. The introduction of the raider attacks register will be an effective measure to warn potential investors and counterparties about the dangers of cooperation with certain companies. The state register should be bilingual (Ukrainian and English) and contain information on the attempts and cases of raider attacks on property and corporate business rights. Also for further innovations in starting a business, Ukraine must pay attention to New Zealand’s and Finland’s experience. © Bogdan V. Derevyanko, Vitaliy M. Pashkov, Olha A. Turkot, Nadiia V. Zahrisheva, Olena S. Bisiuk, 2020.

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3.
Pashkov, V. .
    Advertising of Medical Devices: Foreign Experience and Ukrainian Practice [Текст] / V. Pashkov, A. Harkusha, O. Bytiak // Wiadomosci lekarskie. - 2017. - Vol. 70. Issue: 3 pt 1. - P. 456-461
   Перевод заглавия: Реклама медицинских приборов: зарубежный опыт и украинская практика
УДК
ББК Р

Аннотация: INTRODUCTION: Chosen European foreign policy vector for Ukraine establishes its obligation to enforce the process of adaptation of the EU law regulations in the internal legal policy. The approximation of Ukrainian law to the European Union (EU) "acquis communautaire" is not only the instrument for deepening our economic cooperation with the European Union, but also the important measure to enhance further development of Ukraine in general. National legislation, which regulate advertising and promotion of medical devices (MD), is not an exception. Some key points on legal regulation of abovementioned sphere is a base of this study. MATERIALS AND METHODS: Ukrainian legislation, European Union`s Law Acts, EU's member-states law, WHO Acts and Recommendations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: In accordance with Ukrainian legislation, there is no special law that concerns advertising on MD in Ukraine, this sphere is regulated by general law that named ≪About advertisement≫, but it doesn't take into account even main characteristics of such a special object as medical devices (MD). Moreover, the law ≪About advertisement≫ contain discrepancies in terms that are used, these contradictions, in our opinion, must be eliminated by appropriate law reforms. CONCLUSION: The advertising and promotion of MD in EU is regulated by a combination of EU and national legislation of EU Member States, national advertising and promotion of MD are not harmonized with the EU MDD for now, resulting in a fragmented legal landscape that differs from one EU Member State to the other. Practice of adopting different codes and guides that regulate advertising, including advertising of MD, is widespread in EU and EU Member States and thus must be used in Ukraine with appropriate reformation of national law.

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4.
Pashkov, V. .
    Ambient air protection in the system of public health and biological security legal provision [Text] / V. Pashkov, M. V. Trotska, L. M. Nikolenko // Wiadomosci lekarskie. - 2021. - Vol. 74, Iss. 9 cz 1. - P. 2207-2212
   Перевод заглавия: Охорона атмосферного повітря в системі правового забезпечення охорони здоров'я та біологічної безпеки
УДК
РУБ DOI: 10.36740/WLek202109132

Аннотация: The article examines the legal and regulatory basis for ambient air protection as an essential element of the environment that affects biological security the health and livelihoods of the population. Proper legal regulation of ambient air protection is important in the implementation of various measures aimed at preserving its quality and, accordingly, preventing possible adverse effects on human health. Ambient air protection is a certain activity directed at reducing the number of pollutants that get into the air by one means or another. In the process of environmental protection in general and ambient air protection in particular, the legal basis and case law are important components that aimed to minimize the occurrence of potential hazards that could threaten the health and lives of the population, and in case of such situations, identify the causes of their occurrence and respond to them proportionally.

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5.
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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6.
Pashkov, V. .
    Assisted reproductive technologies: the problems of legal enforcement [Текст] / V. Pashkov, A. Lyfar // Wiadomosci lekarskie. - 2018. - Vol. 71, Issue: 5. - P. 1066-1070
   Перевод заглавия: Вспомогательные репродуктивные технологии: проблемы правоприменения
УДК
ББК Р11

Аннотация: OBJECTIVE: Introduction: Today, the use of assisted reproductive technologies (including surrogacy) is an effective method of guaranteeing realization of person's right on maternity or paternity. Through therapeutic efficiency reproductive means have become incredibly popular among population. However, the lack of certain legal relations in the sphere of surrogacy (both at the international level and the national one) leads to the confusion in the theory and practice. The aim: In this article, the author has set himself the following aims: a) to determine the state of legal regulation of surrogate maternity at national and international levels; b) to focus on problematic moments in legal regulation of surrogacy, which cause such phenomena as medical tourism and human trafficking; c) to investigate the regimes of legal regulation of surrogacy in the countries of the world. PATIENTS AND METHODS: Materials and methods: The methodological framework of the research consists of general scientific and special methods. The dialectical method is used to identify the term surrogacy and its meaning; the method of summarization is applied to the case laws (judgements of European Court of Human Rights and other high legislative bodies of foreign countries). The statistical method is applied to statistical data; the formal method is used for analysing the experience of such foreign countries as the USA (state Illinois, Nevada, California), Sweden, the Netherlands, India, Great Britain. Lastly, the method of comparison is applied to determine the similarities or differences between domestic and foreign legislation. RESULTS: Review: There are three regimes of surrogacy in the world which contradict one another (altruistic, permitting and prohibiting). The difference between legal regulations of surrogacy contributes expansion of such a phenomenon as medical tourism. CONCLUSION: Conclusions: Owing to absence of unified principles and standards on international level in the sphere of surrogacy, subjects of such legal relations are absolutely unprotected. Such phenomena as medical tourism, human trafficking and commercial exploitation of surrogate mothers are extending.

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7.
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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8.
Pashkov, V. M..
    Challenges of classification of stand-alone software as a medical device [Текст] / V. M. Pashkov, O. S. Soloviov, Ye. O. Harkusha // Wiadomosci lekarskie. - 2021. - Vol. 74, Iss. 2. - P. 327-333
   Перевод заглавия: Проблемы классификации автономного программного обеспечения как медицинское устройство
УДК

Аннотация: Through a broad literature review, analysis of EU, USA, Ukraine regulation acts, scientific research, and opinions of progressive-minded people in this sphere, this paper provides a guide to understanding the essence of classification of stand-alone software with medical purpose and specifics of its regulation. This research is based on dialectical, comparative, analytic, synthetic, and comprehensive methods.

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9.
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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10.
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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Умовні позначення місця знаходження

3_пов.(ЗПІ) – зала правової інформації, НБК

4_пов.(НАб) – абонемент наукової літератури, НБК

4_пов.(ДБФ) – довідково-бібліографічний фонд, НБК

5_пов.(З/П) – зала періодичних видань, НБК

6_пов.(АХЛ) – абонемент художньої літератури, НБК

6_пов.(ЗІЛ) – зала літератури іноземними мовами, НБК

7_пов.(Хр) – книгосховище, НБК

8_пов.(РК) – книгосховище рідкісних видань та дисертацій, НБК

НБВ – інформаційно-бібліографічний відділ, НБК, 7 поверх

Ст.Аб. – студентський абонемент, НБК, 5 поверх

Філ №1 – філія № 1 (вул. Динамівська, 4)

Філ №2 – філія № 2 (вул. Пушкінська, 106)

Полт. фак. – Полтавський юридичний інститут, м. Полтава