Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.

Вид документа : Статья из журнала
Шифр издания : 61/P30
Автор(ы) : Pashkov, Vitalii, Harkusha, Andrii
Заглавие : Certain aspects on medical devices software law regulation
Место публикации : Wiadomości Lekarskie. - 2016. - Vol. LXIX, nr 6. - S.765-767
УДК : 61
ББК : Р
Ключевые слова (''Своб.индексиров.''): квалификация и классификация--ответственная организация--программное обеспечение медицинского назначения
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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Вид документа : Статья из журнала
Шифр издания : 61/P30
Автор(ы) : Pashkov, Vitalii, Gutorova, Nataliya, Harkusha, Andrii
Заглавие : Medical device software: defining key term
Место публикации : Wiadomości Lekarskie. - 2016. - Tom LXIX, nr 6. - P.813-817
УДК : 61
ББК : Р
Ключевые слова (''Своб.индексиров.''): критерии различий--методические рекомендации--автономное программное обеспечение--медицинское программное обеспечение устройства
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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Вид документа : Статья из журнала
Шифр издания : 61/P30
Автор(ы) : Pashkov, Vitalii, Hrekov Y., Hrekova M.
Заглавие : European Experience of Regulating Distance Selling of Medicines for Ukraine
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70, № 1. - pp.96-100
УДК : 61
ББК : Х623.211.84
Ключевые слова (''Своб.индексиров.''): украина--риски приобретения лекарств--дистанционная продажа лекарств
Аннотация: INTRODUCTION: Some countries have already tried and tested mechanisms of regulating distance sales as form of distribution of medicines that have been used more or less effectively for a fairly long time. Herewith, so far, the approach of the competent authorities of some countries including Ukraine can be called prevailing in quantitative terms under which the official prohibition on distance sales of medicines is set. AIM: The aim of this study is a detailed examination of the nature of the prohibition of the medicines distance selling in Ukraine, namely the an analysis of advantages and disadvantages of this form of distribution of medicines and identification of appropriate ways for gradual repeal of the prohibition in terms of regulatory reform in Ukraine in the sphere of circulation of medicines due to the process of adaptation of statutory regulation in this area to the EU legislation. MATERIAL AND METHODS: This study is based on Ukrainian regulation acts, Council Directives 97/7/EC, 2000/31/EC, 2001/83/EC, scientific works and opinions of progressiveminded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the article. CONCLUSION: Reception of the described experience of regulation in EU will allow a further review of the principles of regulation in Ukraine in the sphere of medicines with a shift in the main emphasis in the direction of ensuring adequate consumer rights in this area and preventing the risks of patients' and public health.
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4.

Вид документа : Статья из журнала
Шифр издания : 6/P30
Автор(ы) : Pashkov, Vitalii, Harkusha, Andrii, Bytiak, Olekcii
Заглавие : Advertising of Medical Devices: Foreign Experience and Ukrainian Practice
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70. Issue: 3 pt 1. - P.456-461
УДК : 6
ББК : Р
Ключевые слова (''Своб.индексиров.''): маркировка ce--реклама--сравнительная реклама--директива--медицинское оборудование--вводящая в заблуждение реклама
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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5.

Вид документа : Статья из журнала
Шифр издания : 347/P30
Автор(ы) : Pashkov, Vitalii M., Harkusha, Andrii
Заглавие : 3-D Bioprinting Law Regulation Perspectives
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 3 pt 1. - p.480-482
УДК : 347
ББК : Х833
Ключевые слова (''Своб.индексиров.''): 3-d биопринтинг--технологии биотрансляции--правовое регулирование трехмерного биотрансляции--патентование
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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6.

Вид документа : Статья из журнала
Шифр издания : 61/P30
Автор(ы) : Pashkov, Vitalii M., Kotvitska, Alla, Harkusha, Andrii O.
Заглавие : Legal Regulation of the Production and Trade of Medical Devices and Medical Equipment in the EU and US: Experience for Ukraine
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P.614-618
УДК : 61
ББК : Х623.211.84
Ключевые слова (''Своб.индексиров.''): опыт ес и сша в области производства и регулирования лекарственных средств--регулирование производства и торговли медицинскими приборами
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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7.

Вид документа : Статья из журнала
Шифр издания : 61/P30
Автор(ы) : Pashkov, Vitalii M., Hrekov, Yevhen, Hrekova, Maryna
Заглавие : The Directions of Development of Legal Regulation of Patenting the Methods of Treatment in Ukraine Considering the European and World Experience
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P.628-632
УДК : 61
ББК : Р
Ключевые слова (''Своб.индексиров.''): патентование методов лечения--изобретение в медицинской области--патентование в медицинской области--теория непромышленной медицины--социально-этическая теория
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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8.

Вид документа : Статья из журнала
Шифр издания : 61/P30
Автор(ы) : Pashkov, Vitalii, Hutorova N., Harkusha, Andrii
Заглавие : Vat Rates on Medical Devices: Foreign Experience and Ukrainian Practice
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70. Issue:2 pt 2. - P.345-347
УДК : 61
ББК : Р
Ключевые слова (''Своб.индексиров.''): ставки ндс--медицинское оборудование--фармацевтические продукты
Аннотация: Abstract INTRODUCTION: In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. MATERIAL AND METHODS: Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. DISCUSSION: In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. CONCLUSION: In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.
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Вид документа : Статья из журнала
Шифр издания : 6/P30
Автор(ы) : Pashkov, Vitalii M., Soloviov, Aleksey, Olefir, Andrii
Заглавие : Legal Aspects of Counteracting the Trafficking of Falsified Medicines in the European Union
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:4. - P.843-849
УДК : 6
ББК : Х623.211.84
Ключевые слова (''Своб.индексиров.''): директива 2001/83 / ec--положение (ес) 2016/161--подделка--уголовная ответственность--фальсифицированные наркотики--некачественные препараты--уникальный идентификатор
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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Вид документа : Статья из журнала
Шифр издания : 349.6/P30
Автор(ы) : Pashkov, Vitalii M., Batyhina, Olena M., Trotska, Maryna V.
Заглавие : Concept of Waste and its Impact on Human Health
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70, No. 5. - P.964-969
УДК : 349.6
ББК : Х625.80
Ключевые слова (''Своб.индексиров.''): опасные отходы--окружающая среда--здоровье человека--отходы--классификация отходов
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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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