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

Вид документа : Однотомное издание
Шифр издания : 61
Автор(ы) : Pashkov, Vitaliy M., Golovanova, Iryna A. , Olefir A. O.
Заглавие : The impact of the legal regime of intellectual property protection in the pharmaceutical market
Место публикации : Wiadomości Lekarskie. - 2016. - Vol. LXIX, nr 3, cz. II. - S.582 - 586
УДК : 61
ББК : Р45
Ключевые слова (''Своб.индексиров.''): интеллектуальная собственность--изобретение--патенты--фармацевтический рынок--фармацевтические препараты
Аннотация: INTRODUCTION: the functioning of the healthcare industry in any country is impossible without providing enough medicines for patient care. This problem can best be resolved only when the majority of drugs, especially vital, will be made at national plants (industry). In this context, competition from generic drugs is the most optimal strategy to reduce drug's prices. AIM: the paper should examine how the legal regime of intellectual property affects the availability of medicines for people and identify ways of supporting breakthrough inventions and counter ≪unreal innovations≫. MATERIALS AND METHODS: for the purpose of study were generalized information from the scientific journals of medical and legal perspective, monographs by using a set of scientific methods. Namely under systematic approach have been analyzed the problems of pharmaceutical market, ways of producing generic and original drugs. Comparative legal method was useful for learning features of flexible mechanisms of the TRIPS Agreement and market regulation of medicines in the world. RESULTS: based on the research was found that developed countries with strong pharmaceutical industry are interested in maximizing the protection of intellectual property rights, including importing countries. Flexible mechanisms of the TRIPS Agreement can be useful for developing countries. CONCLUSIONS: thus, successful development of pharmaceutical industry and health care should be accompanied by the following measures: - improvement of public health must be recognized as a main task of government policy; - substantial state support aimed at increasing the availability of drugs in the domestic market and the strengthening of export potential; - decrease patent protection of medicines and stimulate market launch of generic copies. Вступ: функціонування галузі охорони здоров'я в будь-якій країні неможливе без забезпечення пацієнтів ліками у достатній мірі. Ця проблема може бути вирішена тільки тоді, коли більшість ліків, особливо життєво важливих, вироблятимуться у національній промисловості. У зв'язку з цим, конкуренція з боку універсальних препаратів є найбільш оптимальною стратегією зниження цін на ліки. Мета: розглянути як правовий режим інтелектуальної власності негативно позначається на доступності лікарських засобів для населення та визначити шляхи підтримки проривних винаходів та «нереальних інновацій». Матеріали і методи: для цілей дослідження були узагальнені відомості з наукових журналів, медичної та юридичної точки зору, монографій, використовуючи набір наукових методів. Саме в рамках системного підходу проаналізовано проблеми фармацевтичного ринку, способи виробництва універсальних і оригінальних препаратів. Порівняльно-правовий метод був корисний для вивчення особливостей гнучких механізмів Угоди ТРІПС та регулювання ринку лікарських засобів у світі. Результати: на підставі досліджень було встановлено, що розвинені країни з потужною фармацевтичною промисловістю, зацікавлені в максимізації захисту прав інтелектуальної власності, в тому числі країн-імпортерів. Гнучкі механізми Угоди ТРІПС можуть бути корисні для країн, що розвиваються. Висновки: таким чином, для успішного розвитку фармацевтичної галузі і охорони здоров’я повинні бути забезпечені наступні заходи: - поліпшення здоров’я населення має бути визнано в якості основних завдань державної політики; - суттєва державна підтримка, спрямована на підвищення доступності ліків на вітчизняному ринку і зміцнення експортного потенціалу; - зниження патентної охорони лікарських засобів і виведення на ринок універсальних препаратів.
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Вид документа : Статья из журнала
Шифр издания : 61/P30
Автор(ы) : Pashkov, Vitaliy M., Golovanova, Iryna A. , Noha, Petro P.
Заглавие : Principle of serviceability and gratuitousness in transplantation?
Место публикации : Wiadomości Lekarskie. - 2016. - Vol. LXIX. nr 3. cz. II. - S.565 - 568
УДК : 61
ББК : Р45
Ключевые слова (''Своб.индексиров.''): доноры--получатель--трансплантация
Аннотация: INTRODUCTION: the issue of commercialization of transplantation analyses in the article. Attention is paid to the importance of transplantation as a method of treatment and saving human lives. AIM: the clarify the feasibility of the introduction of donation commercialization as an avenue to solve the shortage of donor organs and means of combating with black organ market and finding alternative avenues solving these problems, which are more morally acceptable for society is the aim of this article. MATERIALS AND METHODS: the experience of foreign countries has been analyses in the research. Additionally, we used data from international organizations, conclusions scientists and report of Global Financial Integrity in the research. RESULTS: it is impossible to solve most problems by means of paid donation. CONCLUSIONS: therapeutic organ and tissue cloning based on genetic technology is the best way out and solving ethical transplantation problems.The impact of the legal regime of intellectual property protection in the pharmaceutical marketВступ: в статті аналізується питання про комерціалізацію трансплантації. Увагу приділено важливості трансплантації як методу лікування і порятунку людських життів. Мета: уточнити доцільність введення комерціалізації донорства як шлях для вирішення проблеми дефіциту донорських органів і способи боротьби з чорним ринком органів та знаходження альтернативних шляхів вирішення цих проблем, які є більш морально прийнятними для суспільства. Матеріали і методи: в дослідженні аналізується досвід зарубіжних країн. Крім того, в дослідженні використовувалися дані міжнародних організацій, висновки вчених і доповідь Global Financial Integrity. Результати: неможливо вирішити більшість проблем за допомогою платного донорства. Висновки: терапевтичне клонування органів і тканин на основі генної технології - це кращий вихід із ситуації і вирішення етичних проблем трансплантології.
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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, Vitaliy M., Olefir A. O., Bytyak, Oleksiy
Заглавие : Legal Features of the Drug Advertising
Место публикации : Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 1 . - p.133-138
УДК : 61
ББК : Р
Ключевые слова (''Своб.индексиров.''): директива 2001/83 / ec--регулирование безрецептурных препаратов--лекарственные средства--предписание--отпускаемые по рецепту лекарства--реклама
Аннотация: Abstract INTRODUCTION:In the article discribed current trends of advertising in the pharmaceutical market and foreign experience of legal regulation of these relations. As for the advertising of medicines identified it's symptoms, types, basic rules and prohibitions. Modern pharmaceutical companies can not successfully carry out economic activities without advertising. Besides we can mention some fundamental changes in society (information overload, universal access to internet, social media, freedom of movement of goods, labor and finance), also self-medication becomes more popular. At the same time, the number of deaths after improper and uncontrolled use of drugs ranks fifth in the world among the causes of death. AIM:Investigate current trends of advertising on the pharmaceutical market, find advertising signs, basic restrictions and prohibitions on advertising of medicines, as well as foreign experience of legal regulation of these relations. MATERIAL AND METHODS:Despite the fact that pharmaceutical advertising were studied by such scholars as M. Abraham, L. Bradley, C. Dunn, J. Donoh'yu, D. Castro, M. Lipski, K. Taylor and others, number of issues related features of drug advertising, remained without proper theoretical studies. RESULTS:Based on the analysis can come to the conclusion that advertising of medicinal products are the subject of special attention from the state. Drugs, unlike other products, are a group of specialized consumer products. Risks increase when patients under the influence of «aggressive» advertising resort to self-medication. If a complete ban on advertising of medicines is inappropriate, you should set stricter requirements for the content of advertising and product placement rules. That is, in the national legislation to implement regulatory requirements of Directive 2001/83 / EC. CONCLUSIONS:Legal regulation of drug advertising can be improved by such legal means: - should provide for a mechanism of public control over the observance of ethical standards in the advertising of medicinal products; - Prohibit the advertising of medicines for children, as well as drugs for the treatment of infectious, parasitic diseases and pathogens of these diseases, chronic insomnia, cardiovascular diseases, and those costs are reimbursed by government programs or trade names may lead to mix with prescription drugs; - Adopt ethical standards (codes) promotion of drugs for pharmaceutical companies; - Advertising to the public shall not contain any reference to cost or pricing features for medicines.
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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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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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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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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 : Р11/P30
Автор(ы) : Pashkov, Vitaliy M., Batyhina, Olena M., Leiba, Liudmyla
Заглавие : Ensuring right to organic food in public health system
Место публикации : Wiadomosci lekarskie. - 2018. - Vol. 71, Issue: 1 pt 2. - P.226-229
УДК : 61
ББК : Р11
Ключевые слова (''Своб.индексиров.''): здоровье человека--органическая еда--окружающая среда--сельское хозяйство
Аннотация: OBJECTIVE: Introduction: Human health directly depends on safety and quality of food. In turn, quality and safety of food directly depend on its production conditions and methods. There are two main food production methods: traditional and organic. Organic food production is considered safer and more beneficial for human health. Aim: to determine whether the organic food production method affects human health. PATIENTS AND METHODS: Materials and methods: international acts, data of international organizations and conclusions of scientists have been examined and used in the study. The article also summarizes information from scientific journals and monographs from a medical and legal point of view with scientific methods. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. The problems of effects of food production methods and conditions on human health have been analyzed within the framework of the system approach. CONCLUSION: Conclusions: Food production methods and conditions ultimately affect the state and level of human health. The organic method of production activity has a positive effect on human health.
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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