Download or read book Cryptocurrencies and the Regulatory Challenge written by Allan C. Hutchinson and published by Routledge. This book was released on 2021-11-10 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a social process that places great stock in its stability and predictability, law does not deal easily or well with change. In a modern world that is in a constant and rapid state of flux, law is being placed under considerable stress in its efforts to fulfill its task as a primary regulator of social and economic behaviour. This challenge is particularly acute in the realm of technology and its profound ramifications for social and economic behaviour. The innovative Techno-Age not only offers fresh ways of handling old problems, but also throws up entirely new problems; traditional ways of thinking about and responding to these old and new problems and their optimal resolution are no longer as tenable as many once thought. One such example is the burgeoning world of cryptocurrencies – this peer-to-peer digital network presents a profound challenge to the status quo of the financial services sector, to the established modes of state-backed fiat currency, and to the regulatory authority and reach of law. Taken together, these related challenges demand the urgent attention of jurists, lawyers and law reformers. It is the future and relevance of legal regulation as much as cryptocurrency that is at stake. This book proposes an approach to regulating cryptocurrency that recognises and retains its innovative and transformative potential, but also identifies and deals with some of its less appealing qualities and implications.

Download or read book Islamic Finance written by Rifaat Ahmed Abdel Karim and published by John Wiley & Sons. This book was released on 2013-04-17 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the world's foremost authorities on the subject, the number-one guide to Islamic finance revised and updated for a post-crisis world Because it is entirely equity-based, rather than credit-based, Islamic finance is immune to the speculative bubbles and runaway volatility typical of Western finance. Especially now, in the wake of the global financial crisis, this has made them increasingly attractive to institutional investors, asset managers and hedge funds in search of more stable alternatives to conventional financial products. With interest in Islamic finance swiftly spreading beyond the Muslim world, the need among finance and investment professionals has never been greater for timely and authoritative information about the rules governing Islamic finance. This thoroughly updated and revised second edition of the premier guide to regulatory issues in Islamic finance satisfies that need. Addresses the need for banks to develop common Islamic-based international accounting and auditing standards Clearly explains the key differences between Shari'ah rulings, standardization of acceptable banking practices, and the development of standardized financial products Explores the role of the Shari'ah Boards in establishing common rules regarding the permissibility of financial instruments and markets Offers guidance for regulators seeking to adapt their regulatory frameworks to the needs of the fast-growing Islamic finance sector

Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Download or read book Shaping Internet Governance Regulatory Challenges written by Rolf H. Weber and published by . This book was released on 2010 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The information society is a key issue in everyday life and a phenomenon enc- passing social, cultural, economic, and legal facettes. Currently, an information society's legal framework is gradually crystallizing under the newly introduced term of "Internet governance". During the last few years, intensive discussions about the contents of Internet governance have addressed manifold aspects of a possible regulatory regime. In light of the general comprehension that an international treaty structure is mi- ing and that self-regulation as a normative model does not sufce in all respects, new architectural and constitutional theories have been developed; furthermore, the international body of the Internet Governance Forum (IGF) came to life. N- withstanding the available literature on IGF, however, a thorough and systematic study sheding light on the main topics of Internet governance (such as legitimacy, transparency, accountability, and participation) and on the key regulatory issues (for example critical Internet resources, access, protection of civil liberties/- man rights, realization of security, safety and privacy standards, as well as the overcoming of the digital divide) from a legal perspective is not yet at hand. The present publication aims at discussing these legal challenges. This book has benefted from many inputs and encouragements from colleagues that I am deeply grateful for. In particular, I am indebted to the very meaningful discussions and valuable support in the preparation of the publication by my - search assistants lic. iur Mirin . a Grosz and lic. iurR . omana Weber, to lic. iur.

Download or read book Achieving Regulatory Excellence written by Cary Coglianese and published by Brookings Institution Press. This book was released on 2016-12-20 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Whether striving to protect citizens from financial risks, climate change, inadequate health care, or the uncertainties of the emerging “sharing” economy, regulators must routinely make difficult judgment calls in an effort to meet the conflicting demands that society places on them. Operating within a political climate of competing demands, regulators need a lodestar to help them define and evaluate success. Achieving Regulatory Excellence provides that direction by offering new insights from law, public administration, political science, sociology, and policy sciences on what regulators need to do to improve their performance. Achieving Regulatory Excellence offers guidance from leading international experts about how regulators can set appropriate priorities and make sound, evidence-based decisions through processes that are transparent and participatory. With increasing demands for smarter but leaner government, the need for sound regulatory capacity—for regulatory excellence—has never been stronger.

Download or read book Applied Ethics in a Digital World written by Vasiliu-Feltes, Ingrid and published by IGI Global. This book was released on 2021-11-19 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: As advances in disruptive technologies transform politics and increase the velocity of information and policy flows worldwide, the public is being confronted with changes that move faster than they can comprehend. There is an urgent need to analyze and communicate the ethical issues of these advancements. In a perpetually updating digital world, data is becoming the dominant basis for reality. This new world demands a new approach because traditional methods are not fit for a non-physical space like the internet. Applied Ethics in a Digital World provides an analysis of the ethical questions raised by modern science, technological advancements, and the fourth industrial revolution and explores how to harness the speed, accuracy, and power of emerging technologies in policy research and public engagement to help leaders, policymakers, and the public understand the impact that these technologies will have on economies, legal and political systems, and the way of life. Covering topics such as artificial intelligence (AI) ethics, digital equity, and translational ethics, this book is a dynamic resource for policymakers, civil society, CEOs, ethicists, technologists, security advisors, sociologists, cyber behavior specialists, criminologists, data scientists, global governments, students, researchers, professors, academicians, and professionals.

Download or read book Technical Commercial and Regulatory Challenges of QoS written by XiPeng Xiao and published by Morgan Kaufmann. This book was released on 2008-10-27 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technical, Commerical and Regulatory Challenges of QoS provides a comprehensive examination of Internet QoS theory, standards, vendor implementation and network deployment from the practitioner's point of view, including extensive discussion of related economic and regulatory issues. Written in a technology-light way so that a variety of professionals and researchers in the information and networking industries can easily grasp the material. Includes case studies based on real-world experiences from industry. The author starts by discussing the economic, regulatory and technical challenges of the existing QoS model. Key coverage includes defining a clear business model for selling and buying QoS in relation to current and future direction of government regulation and QoS interoperability (or lack thereof) between carriers and networking devices. The author then demonstrates how to improve the current QoS model to create a clear selling point, less regulation uncertainty, and higher chance of deployment success. This includes discussion of QoS re-packaging to end-users; economic and regulatory benefits of the re-packaging; and the overall benefits of an improved technical approach. Finally, the author discusses the future evolution of QoS from an Internet philosophy perspective and lets the reader draw the conclusions. This book is the first QoS book to provide in depth coverage on the commercial and regulatory aspects of QoS, in addition to the technical aspect. From that, readers can grasp the commercial and regulatory issues of QoS and their implications on the overall QoS business model. This book is also the first QoS book to provide case studies of real world QoS deployments, contributed by the people who did the actual deployments. From that, readers can grasp the practical issues of QoS in real world. This book is also the first QoS book to cover both wireline QoS and wireless QoS. Readers can grasp the QoS issues in the wireless world. The book was reviewed and endorsed by a long list of prominent industrial and academic figures. - Discusses QoS technology in relation to economic and regulatory issues - Includes case studies based on real-world examples from industry practitioners - Provides unique insight into how to improve the current QoS model to create a clear selling point, less regulatory uncertainty, and higher chance of deployment success

Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.

Download or read book The Regulatory Craft written by Malcolm K. Sparrow and published by Rowman & Littlefield. This book was released on 2011-01-01 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Does Regulation Kill Jobs written by Cary Coglianese and published by University of Pennsylvania Press. This book was released on 2014-01-06 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: As millions of Americans struggle to find work in the wake of the Great Recession, politicians from both parties look to regulation in search of an economic cure. Some claim that burdensome regulations undermine private sector competitiveness and job growth, while others argue that tough new regulations actually create jobs at the same time that they provide other benefits. Does Regulation Kill Jobs? reveals the complex reality of regulation that supports neither partisan view. Leading legal scholars, economists, political scientists, and policy analysts show that individual regulations can at times induce employment shifts across firms, sectors, and regions—but regulation overall is neither a prime job killer nor a key job creator. The challenge for policymakers is to look carefully at individual regulatory proposals to discern any job shifting they may cause and then to make regulatory decisions sensitive to anticipated employment effects. Drawing on their analyses, contributors recommend methods for obtaining better estimates of job impacts when evaluating regulatory costs and benefits. They also assess possible ways of reforming regulatory institutions and processes to take better account of employment effects in policy decision-making. Does Regulation Kills Jobs? tackles what has become a heated partisan issue with exactly the kind of careful analysis policymakers need in order to make better policy decisions, providing insights that will benefit both politicians and citizens who seek economic growth as well as the protection of public health and safety, financial security, environmental sustainability, and other civic goals. Contributors: Matthew D. Adler, Joseph E. Aldy, Christopher Carrigan, Cary Coglianese, E. Donald Elliott, Rolf Färe, Ann Ferris, Adam M. Finkel, Wayne B. Gray, Shawna Grosskopf, Michael A. Livermore, Brian F. Mannix, Jonathan S. Masur, Al McGartland, Richard Morgenstern, Carl A. Pasurka, Jr., William A. Pizer, Eric A. Posner, Lisa A. Robinson, Jason A. Schwartz, Ronald J. Shadbegian, Stuart Shapiro.

Download or read book Combination Products written by Smita Gopalaswamy and published by CRC Press. This book was released on 2008-04-22 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing

Download or read book Innovation and the State written by Cristie Ford and published by Cambridge University Press. This book was released on 2017-12-07 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: From social media to mortgage-backed securities, innovation carries both risk and opportunity. Groups of people win, and lose, when innovation changes the ground rules. Looking beyond formal politics, this new book by Cristie Ford argues that we need to recognize innovation, and financial innovation in particular, as a central challenge for regulation. Regulation is at the leading edge of politics and policy in ways that we have not yet fully grasped. Seemingly innocuous regulatory design choices have clear and profound practical ramifications for many of our most cherished social commitments. Innovation is a complex phenomenon that needs to be understood not only in technical terms, but also in human ones. Using financial regulation as her primary example, Ford argues for a fresh approach to regulation, which recognizes innovation for the regulatory challenge that it is, and which binds our cherished social values and our regulatory tools ever more tightly together.

Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Small Satellites written by Irmgard Marboe and published by BRILL. This book was released on 2016-03-11 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Small Satellites – Regulatory Challenges and Chances edited by Irmgard Marboe addresses the booming phenomenon of small satellites. The rapid innovation of technology has made it possible to develop, launch and operate small satellites at rather low costs. Universities, start-ups and also governments see the chance to access outer space more easily and inexpensively. Yet, the importance to comply with existing rules and regulations that are in place to ensure that outer space is used and explored in a safe and responsible manner is sometimes overlooked. The book addresses this challenge and shows how it can be met. The contributors are renowned academics and practicioners from many different countries that share their experiences and insights and suggest practical solutions.

Download or read book Legal and Regulatory Issues in Human Resources Management written by Ronald R. Sims and published by IAP. This book was released on 2014-10-01 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited book is intended to address the need for an updated look at the HRM legal and regulatory environment. Contrary to existing books which address legal issues in HRM from a narrower focus or specific issue (like sexual harassment, performance appraisal or employment termination), this book provides a comprehensive and in-depth look at legal issues, regulations and laws which govern all aspects of human resource management—recruitment, selection, placement, performance management (i.e., employee training and development), benefits and compensation—and specific issues such as job analysis, sexual harassment, and the like. The contributors to this book offer their insight derived from their own research and practical experience with the HRM legal and regulatory environment/world of work. More specifically, the contributors examine, analyze and discuss challenges, issues and opportunities related to HRM legal and regulatory issues and the implications for employees and their organizations while emphasizing the importance of navigating such laws and regulations to the employment cycle and toward sustainable competitive advantage in today’s and tomorrow’s organizations.

Download or read book Handbook of Research on Innovation and Development of E Commerce and E Business in ASEAN written by Almunawar, Mohammad Nabil and published by IGI Global. This book was released on 2020-08-28 with total page 883 pages. Available in PDF, EPUB and Kindle. Book excerpt: Business-to-consumer (B2C) and consumer-to-consumer (C2C) e-commerce transactions, including social commerce, are rapidly expanding, although e-commerce is still small when compared to traditional business transactions. As the familiarity of making purchases using smart devices continues to expand, many global and regional investors hope to target the ASEAN region to tap into the rising digital market in this region. The Handbook of Research on Innovation and Development of E-Commerce and E-Business in ASEAN is an essential reference source that discusses economics, marketing strategies, and mobile payment systems, as well as digital marketplaces, communication technologies, and social technologies utilized for business purposes. Featuring research on topics such as business culture, mobile technology, and consumer satisfaction, this book is ideally designed for policymakers, financial managers, business professionals, academicians, students, and researchers.

Download or read book Microbiological Sensors for the Drinking Water Industry written by Tapio Katko and published by IWA Publishing. This book was released on 2019-02-15 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book addresses the interdisciplinary area of water quality monitoring and binds together interests and competences within sensing technology, system behaviour, business needs, legislation, education, data handling, and artificial response algorithms.