Національний юридичний університет імені Ярослава Мудрого ⚖ Головна ⓘ Довiдка
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1.
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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2.
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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3.
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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4.
Pashkov, V. .
    Vat Rates on Medical Devices: Foreign Experience and Ukrainian Practice [Текст] / V. Pashkov, N. Hutorova, A. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70. Issue:2 pt 2. - P. 345-347
   Перевод заглавия: Тарифы на медицинские приборы: зарубежный опыт и украинская практика
УДК
ББК Р

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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5.
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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6.
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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7.
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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8.
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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9.
Pashkov, V. .
    European Experience of Regulating Distance Selling of Medicines for Ukraine [Текст] / V. Pashkov, Y. Hrekov, M. Hrekova // Wiadomosci lekarskie. - 2017. - Vol. 70, № 1. - pp. 96-100
   Перевод заглавия: Европейский опыт регулирования дистанционной продажи лекарств для Украины
УДК
ББК Х623.211.84

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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10.
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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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