Neuroscience Trials of the Future PDF Download

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442583
Category : Medical
Languages : en
Pages : 111

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Book Description
On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Author: Tehrani, Pardis Moslemzadeh
Publisher: IGI Global
ISBN: 1799879291
Category : Computers
Languages : en
Pages : 273

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Book Description
The convergence of Artificial Intelligence (AI) in blockchain creates one of the world’s most reliable technology-enabled decision-making systems that is virtually tamper-proof and provides solid insights and decisions. The integration of AI and Blockchain affects many aspects from food supply chain logistics and healthcare record sharing to media royalties and financial security. It is imperative that regulatory standards are emphasized in order to support positive outcomes from the integration of AI in blockchain technology. Regulatory Aspects of Artificial Intelligence on Blockchain provides relevant legal and security frameworks and the latest empirical research findings in blockchain and AI. Through the latest research and standards, the book identifies and offers solutions for overcoming legal consequences that pertain to the application of AI into the blockchain system, especially concerning the usage of smart contracts. The chapters, while investigating the legal and security issues associated with these applications, also include topics such as smart contacts, network vulnerability, cryptocurrency, machine learning, and more. This book is essential for technologists, security analysts, legal specialists, privacy and data security practitioners, IT consultants, standardization professionals, researchers, academicians, and students interested in blockchain and AI from a legal and security viewpoint.

Author: Graham Russell
Publisher: Bloomsbury Publishing
ISBN: 1509918590
Category : Law
Languages : en
Pages : 505

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Book Description
This ground-breaking book addresses the challenge of regulatory delivery, defined as the way that regulatory agencies operate in practice to achieve the intended outcomes of regulation. Regulatory reform is moving beyond the design of regulation to address what good regulatory delivery looks like. The challenge in practice is to operate a regulatory regime that is both appropriate and effective. Questions of how regulations are received and applied by those whose behaviour they seek to control, and the way they are enforced, are vital in securing desired regulatory outcomes. This book, written by and for practitioners of regulatory delivery, explains the Regulatory Delivery Model, developed by Graham Russell and his team at the UK Department for Business, Energy and Industrial Strategy. The model sets out a framework to steer improvements to regulatory delivery, comprising three prerequisites for regulatory agencies to be able to operate effectively (Governance Frameworks, Accountability and Culture) and three practices for regulatory agencies to be able to deliver societal outcomes (Outcome Measurement, Risk-based Prioritisation and Intervention Choices). These elements are explored by an international group of experts in regulatory delivery reform, with case studies from around the world. Regulatory Delivery is the first product of members of the International Network for Delivery of Regulation.

Author: Imad A Moosa
Publisher: World Scientific
ISBN: 981310953X
Category : Law
Languages : en
Pages : 423

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Book Description
The book deals with contemporary issues in financial regulation, given the post-crisis regulatory landscape. The major idea put forward is that rampant corruption and fraud in the financial sector provide the main justification for financial regulation. Specific issues that are dealt with include the proposition that the Efficient Market Hypothesis was both a cause and a casualty of the global financial crisis. The book also examines the regulation of remuneration in the financial sector, credit rating agencies and shadow banking. Also considered is financial reform in Iceland and the proposal to move away from fractional reserve banking to a system of sovereign money. A macroeconomic/regulatory issue that is also considered is quantitative easing and the resulting environment of ultra-low interest rates.

Author: Ioanna Hadjiyianni
Publisher: Edward Elgar Publishing
ISBN: 1035314681
Category : Law
Languages : en
Pages : 303

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Book Description
This is an open access title available under the terms of a CC BY-NC-ND 4.0 License. It is free to read, download and share on Elgaronline.com. In this authoritative book, Ioanna Hadjiyianni and Kleoniki Pouikli incisively map out the regulatory landscape of ship recycling, exploring the main international and European regulatory approaches that govern its environmental impacts. In light of the transnational demands of environmental justice, they critically assess the interaction between multiple regimes from the perspective of key environmental principles and the EU’s attempts to steer regulatory developments in this field.

Author: Daan J.A. Crommelin
Publisher: Springer
ISBN: 3319162411
Category : Medical
Languages : en
Pages : 390

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Book Description
The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.

Author: Peter Drahos
Publisher: ANU Press
ISBN: 1760461024
Category : Law
Languages : en
Pages : 820

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Book Description
This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.

Author: André Pereira da Fonseca,
Publisher: Kluwer Law International B.V.
ISBN: 9403506857
Category : Law
Languages : en
Pages : 681

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Book Description
In the process of resolving disputes, it is not uncommon for parties to justify actions otherwise in breach of their obligations by invoking the need to protect some aspect of the elusive concept of public order. Until this thoroughly researched book, the criteria and factors against which international dispute bodies assess such claims have remained unclear. Now, by providing an in-depth comparative analysis of relevant jurisprudence under four distinct international dispute resolution systems – trade, investment, human rights and international commercial arbitration – the author of this invaluable book identifies common core benchmarks for the application of the public order exception. To achieve the broadest possible scope for her analysis, the author examines the public order exception’s function, role and application within the following international dispute resolution systems: relevant World Trade Organization (WTO) agreements as enforced by the organization’s Dispute Settlement Body and Appellate Body; international investment agreements as enforced by competent Arbitral Tribunals and Annulment Committees under the International Center for Settlement of Investment Disputes; provisions under the Inter-American Convention of Human Rights and the European Convention of Human Rights as enforced by the Inter-American Court of Human Rights and the European Court of Human Rights, respectively; and the New York Convention as enforced by national tribunals across the world. Controversies, tensions and pitfalls inherent in invoking the public order exception are elucidated, along with clear guidelines on how arguments may be crafted in order to enhance prospects of success. Throughout, tables and graphs systematize key aspects of the relevant jurisprudence under each of the dispute resolution systems analysed. As an immediate practical resource for lawyers on any side of a dispute who wish to invoke or strengthen a public order exception claim, the book’s systematic analysis will be welcomed by lawyers active in WTO disputes, international investment arbitration, human rights law or enforcement of foreign arbitral awards. Academics and policymakers will find a signal contribution to the ongoing debate on the existence, legal basis, content and functions of the transnational public order.

Author: Roselyn Hsueh Romano
Publisher: Cornell University Press
ISBN: 0801462851
Category : Political Science
Languages : en
Pages : 321

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Book Description
Today's China is governed by a new economic model that marks a radical break from the Mao and Deng eras; it departs fundamentally from both the East Asian developmental state and its own Communist past. It has not, however, adopted a liberal economic model. China has retained elements of statist control even though it has liberalized foreign direct investment more than any other developing country in recent years. This mode of global economic integration reveals much about China’s state capacity and development strategy, which is based on retaining government control over critical sectors while meeting commitments made to the World Trade Organization. In China's Regulatory State, Roselyn Hsueh demonstrates that China only appears to be a more liberal state; even as it introduces competition and devolves economic decisionmaking, the state has selectively imposed new regulations at the sectoral level, asserting and even tightening control over industry and market development, to achieve state goals. By investigating in depth how China implemented its economic policies between 1978 and 2010, Hsueh gives the most complete picture yet of China's regulatory state, particularly as it has shaped the telecommunications and textiles industries. Hsueh contends that a logic of strategic value explains how the state, with its different levels of authority and maze of bureaucracies, interacts with new economic stakeholders to enhance its control in certain economic sectors while relinquishing control in others. Sectoral characteristics determine policy specifics although the organization of institutions and boom-bust cycles influence how the state reformulates old rules and creates new ones to maximize benefits and minimize costs after an initial phase of liberalization. This pathbreaking analysis of state goals, government-business relations, and methods of governance across industries in China also considers Japan’s, South Korea’s, and Taiwan’s manifestly different approaches to globalization.

Author: Malcolm K. Sparrow
Publisher: Rowman & Littlefield
ISBN: 0815798288
Category : Law
Languages : en
Pages : 370

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Book Description
The Regulatory Craft tackles one of the most pressing public policy issues of our time—the reform of regulatory and enforcement practice. Malcolm K. Sparrow shows how the vogue prescriptions for reform (centered on concepts of customer service and process improvement) fail to take account of the distinctive character of regulatory responsibilities—which involve the delivery of obligations rather than just services.In order to construct more balanced prescriptions for reform, Sparrow invites us to reconsider the central purpose of social regulation—the abatement or control of risks to society. He recounts the experiences of pioneering agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem. At the heart of a new regulatory craftsmanship, according to Sparrow, lies the central notion, "pick important problems and fix them." This beguilingly simple idea turns out to present enormously complex implementation challenges and carries with it profound consequences for the way regulators organize their work, manage their discretion, and report their performance. Although the book is primarily aimed at regulatory and law-enforcement practitioners, it will also be invaluable for legislators, overseers, and others who care about the nature and quality of regulatory practice, and who want to know what kind of performance to demand from regulators and how it might be delivered. It stresses the enormous benefit to society that might accrue from development of the risk-control art as a core professional skill for regulators.