scholarly journals Bespoke regulation for bespoke medicine? A comparative analysis of bioprinting regulation in Europe, the USA and Australia

Author(s):  
Jane Nielsen ◽  
Jenny Kaldor ◽  
Adam Irwin ◽  
Cameron Stewart ◽  
Dianne Nicol

Like most health-technology innovators, bioprinters are required to traverse a complex landscape featuring varied forms of regulation. This article focuses on one of the most complex aspects: the requirement imposed by regulatory authorities to satisfy them of the safety, efficacy and clinical utility of resultant healthcare products. Satisfaction of such requirements can result in a significant lag between ‘breakthrough’ and clinical delivery. This article examines this aspect of regulation in the USA, Europe and Australia, three leading bioprinting research jurisdictions. In particular, it examines medical devices and medicines categories of regulation, questioning whether a new approach to regulation is required or whether existing product-based regimes are sufficiently adaptive.

Author(s):  
A.I. Glushchenko ◽  
M.Yu. Serov

В статье рассматривается вопрос совершенствования системы управления параллельно-работающими насосными агрегатами с целью повышения энергоэффективности их работы. Проведено сравнение и выявление недостатков существующих методов решения рассматриваемой проблемы. Предложена идея нового подхода на базе онлайн оптимизации. The problem under consideration is improvement of the energy efficiency of a control system of parallel-running pump units. Known methods used to solve this problem are considered. Their advantages and disadvantages are shown. Finally, the idea of a new approach, which is based on online optimization, is proposed.


Author(s):  
E. Telegina ◽  
M. Tadzhiev

According to judgemental forecasts, in the next few years the revolutionary changes in the energy complex both in the USA and in the world in general are hardly possible, considering the enormous inertia of the energetic system and high expenses coming from the infrastructure supersession, even in case of cost-effective alternatives to the existing energy commodities. At the same time, the sharpening of energy security problems resulting from the growth of a global demand on energy products leads to perceprion of necessity for a new approach to forming the global energy market, and to development of new stability and reliability strategies maintenance for assured supplies of energy products. In recent years, the USA as the biggest consumer of energy resources in the world worked out a new national strategy of energy security provision. Its main targets are: meeting the requirements of the American economy of its own resources, lowering the import-dependence level, high use of innovation technologies, significant increase of investments in alternative energy sources, as well as of resource-and energy-saving.


Author(s):  
Оксана Алексеевна Владимирова

Статья посвящена исследованию опыта оказания бесплатной юридической помощи осужденным к лишению свободы в США, а также проведению сравнительного анализа данного и отечественного опыта. Целью работы является изучение основных организационных аспектов и правовых основ оказания юридической помощи такой категории граждан, как осужденные, с целью установления закономерностей и выявления возможности использования положительных аспектов указанного опыта в российском законодательстве. Методы, использующиеся при написании статьи: диалектический, анализ, синтез, сравнительно-правовой. В статье последовательно изучается организация оказания бесплатной юридической помощи осужденным и их родственникам в различных регионах (штатах) США. Особое внимание уделяется субъектам оказания помощи, а также специфике отдельных механизмов и особенностей работы организаций по оказанию безвозмездной помощи осужденным. В качестве особенности американской системы оказания правовой помощи автор особенно выделяет предметный (специализированный) подход к вопросам оказания помощи - отдельные организации занимаются оказанием помощи по выбранному узкому кругу вопросов. Исследование российского опыта правовой помощи осужденным позволяет отметить некоторые преимущества. Вместе с тем, анализ проблем, существующих в системе оказания бесплатной юридической помощи осужденным к лишению свободы, позволил сделать вывод о необходимости совершенствования системы юридической помощи в России. В результате работы выявлен положительный опыт, возможный для применения в российском законодательстве. The article is devoted to the study of the experience of providing free legal assistance to those sentenced to imprisonment in the United States, as well as to the comparative analysis of this experience and that available in domestic practice. The purpose of this work is to study the main organizational aspects and legal foundations of providing legal assistance to such a category of citizens as convicts in order to establish patterns and identify the possibility of using the positive aspects of this experience in Russian legislation. Methods used in this study: dialectical method of cognition, analysis, synthesis, methods of comparative law. The article consistently examines the organization of the provision of free legal assistance to convicts and their relatives in various regions (states) of the United States. Great attention is paid to the subjects of assistance, as well as the specifics of individual mechanisms and features of the work of organizations to provide gratuitous assistance to convicts. As a feature of the American system of providing legal assistance, the author especially highlights the subject (specialized) approach to assistance issues - individual organizations are involved in providing assistance on a selected narrow range of issues. The study of the Russian experience of legal assistance to convicts reveals some advantages. At the same time, the analysis of the problems existing in the system of providing free legal assistance to those sentenced to imprisonment made it possible to conclude that it is necessary to improve the system of legal assistance in Russia. As a result of the work, a positive experience was revealed that could be applied in Russian legislation.


2018 ◽  
Vol 64 (3) ◽  
pp. 487-501
Author(s):  
Surendra Kumar

Independent regulatory authorities have become an important component of the governance landscape in India and elsewhere. Some regulators have achieved useful outcomes in India. However, the creation of independent sectoral regulators in India has not been accompanied by critical reflection on their role, or attention to the political, legal and institutional contexts within which they operate. Lessons can be learnt from mature regulatory policy countries, such as the USA, the UK and Australia, that the regulatory environment needs to be constantly evaluated to make sure it is keeping pace with the changing technology, business environment and consumer needs and demands. Despite the number of bodies in India that are involved or responsible for regulatory reform, there is one function that seems to be missing and that is of a central oversight function. Most countries have an explicit whole of government regulatory policy and an oversight body, sometimes more than one, that is/are responsible for embedding some of the systemic tools across different parts of the government machinery.


Author(s):  
Ali Obaid Alkaabi ◽  
George Mohay ◽  
Adrian Mccullagh ◽  
Nicholas Chantler

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