Download or read book Fundamentals of International Regulatory Affairs Fifth Edition written by Gloria Hall and published by . This book was released on 2021-06-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Law of the European Union and the European Communities written by Pieter Jan Kuijper and published by Kluwer Law International B.V.. This book was released on 2018-09-28 with total page 1251 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Law of the European Union is a complete reference work on all aspects of the law of the European Union, including the institutional framework, the Internal Market, Economic and Monetary Union and external policy and action. Completely revised and updated, with many newly written chapters, this fifth edition of the most thorough resource in its field provides the most comprehensive and systematic account available of the law of the European Union (EU). Written by a new team of experts in their respective areas of European law, its coverage incorporates and embraces many current, controversial, and emerging issues and provides detailed attention to historical development and legislative history of EU law. Topics that are constantly debated in European legal analysis and practice are touched on in ways that are both fundamental and enlightening, including the following: .powers and functions of the EU law institutions and relationship among them; .the principles of equality, loyalty, subsidiarity, and proportionality; .free movement of persons, goods, services, and capital; .mechanisms of constitutional change – treaty revisions, accession treaties, withdrawal agreements; .budgetary principles and procedures; .State aid rules; .effect of Union law in national legal systems; .coexistence of EU, European Convention of Human Rights (ECHR), and national fundamental rights law; .migration and asylum law; .liability of Member States for damage suffered by individuals; .competition law – cartels, abuse of dominant position, merger control; .social policy, equal pay, and equal treatment; .environmental policy, consumer protection, public health, cultural policy, education, and tourism; .nature of EU citizenship, its acquisition, and loss; and .law and policy of the EU’s external relations. The fifth edition embraces many new, ongoing, and emerging European legal issues. As in the previous editions, the presentation is notable for its attention to how the law relates to economic and political realities and how the various policy areas interact with each other and with the institutional framework. The many practitioners and scholars who have relied on the predecessors of this definitive work for years will welcome this extensively revised and updated edition. Those coming to the field for the first time will instantly recognize that they are in the presence of a masterwork that can always be turned to with profit and that helps in understanding the rationale underlying any EU law provision or principle.
Download or read book Fundamentals of International Regulatory Affairs written by Pamela Anne Jones and published by . This book was released on 2018 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Download or read book Global Business Regulation written by John Braithwaite and published by Cambridge University Press. This book was released on 2000-02-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.
Download or read book Capital Markets Fifth Edition written by Frank J. Fabozzi and published by MIT Press. This book was released on 2015-10-23 with total page 1087 pages. Available in PDF, EPUB and Kindle. Book excerpt: The substantially revised fifth edition of a textbook covering the wide range of instruments available in financial markets, with a new emphasis on risk management. Over the last fifty years, an extensive array of instruments for financing, investing, and controlling risk has become available in financial markets, with demand for these innovations driven by the needs of investors and borrowers. The recent financial crisis offered painful lessons on the consequences of ignoring the risks associated with new financial products and strategies. This substantially revised fifth edition of a widely used text covers financial product innovation with a new emphasis on risk management and regulatory reform. Chapters from the previous edition have been updated, and new chapters cover material that reflects recent developments in financial markets. The book begins with an introduction to financial markets, offering a new chapter that provides an overview of risk—including the key elements of financial risk management and the identification and quantification of risk. The book then covers market participants, including a new chapter on collective investment products managed by asset management firms; the basics of cash and derivatives markets, with new coverage of financial derivatives and securitization; theories of risk and return, with a new chapter on return distributions and risk measures; the structure of interest rates and the pricing of debt obligations; equity markets; debt markets, including chapters on money market instruments, municipal securities, and credit sensitive securitized products; and advanced coverage of derivative markets. Each chapter ends with a review of key points and questions based on the material covered.
Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Download or read book Nurse as Educator written by Susan Bacorn Bastable and published by Jones & Bartlett Learning. This book was released on 2008 with total page 689 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed to teach nurses about the development, motivational, and sociocultural differences that affect teaching and learning, this text combines theoretical and pragmatic content in a balanced, complete style. --from publisher description.
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Download or read book The Federal Reserve System Purposes and Functions written by Board of Governors of the Federal Reserve System and published by . This book was released on 2002 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides an in-depth overview of the Federal Reserve System, including information about monetary policy and the economy, the Federal Reserve in the international sphere, supervision and regulation, consumer and community affairs and services offered by Reserve Banks. Contains several appendixes, including a brief explanation of Federal Reserve regulations, a glossary of terms, and a list of additional publications.
Download or read book FDA Investigations Operations Manual written by Food and Drug Administration and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Download or read book Radio Production written by Robert McLeish and published by CRC Press. This book was released on 2015-09-16 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Radio Production is for professionals and students interested in understanding the radio industry in today’s ever-changing world. This book features up-to-date coverage of the purpose and use of radio with detailed coverage of current production techniques in the studio and on location. In addition there is exploration of technological advances, including handheld digital recording devices, the use of digital, analogue and virtual mixing desks and current methods of music storage and playback. Within a global context, the sixth edition also explores American radio by providing an overview of the rules, regulations, and purpose of the Federal Communications Commission. The sixth edition includes: Updated material on new digital recording methods, and the development of outside broadcast techniques, including Smartphone use. The use of social media as news sources, and an expansion of the station’s presence. Global government regulation and journalistic codes of practice. Comprehensive advice on interviewing, phone-ins, news, radio drama, music, and scheduling. This edition is further enhanced by a companion website, featuring examples, exercises, and resources: www.focalpress.com/cw/mcleish.
Download or read book Regulatory Capitalism written by John Braithwaite and published by Edward Elgar Publishing. This book was released on 2008 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this sprawling and ambitious book John Braithwaite successfully manages to link the contemporary dynamics of macro political economy to the dynamics of citizen engagement and organisational activism at the micro intestacies of governance practices. This is no mean feat and the logic works. . . Stephen Bell, The Australian Journal of Public Administration Everyone who is puzzled by modern regulocracy should read this book. Short and incisive, it represents the culmination of over twenty years work on the subject. It offers us a perceptive and wide-ranging perspective on the global development of regulatory capitalism and an important analysis of points of leverage for democrats and reformers. Christopher Hood, All Souls College, Oxford, UK It takes a great mind to produce a book that is indispensable for beginners and experts, theorists and policymakers alike. With characteristic clarity, admirable brevity, and his inimitable mix of description and prescription, John Braithwaite explains how corporations and states regulate each other in the complex global system dubbed regulatory capitalism. For Braithwaite aficionados, Regulatory Capitalism brings into focus the big picture created from years of meticulous research. For Braithwaite novices, it is a reading guide that cannot fail to inspire them to learn more. Carol A. Heimer, Northwestern University, US Reading Regulatory Capitalism is like opening your eyes. John Braithwaite brings together law, politics, and economics to give us a map and a vocabulary for the world we actually see all around us. He weaves together elements of over a decade of scholarship on the nature of the state, regulation, industrial organization, and intellectual property in an elegant, readable, and indispensable volume. Anne-Marie Slaughter, Princeton University, US Encyclopedic in scope, chock full of provocative even jarring claims, Regulatory Capitalism shows John Braithwaite at his transcendental best. Ian Ayres, Yale Law School, Yale University, US Contemporary societies have more vibrant markets than past ones. Yet they are more heavily populated by private and public regulators. This book explores the features of such a regulatory capitalism, its tendencies to be cyclically crisis-ridden, ritualistic and governed through networks. New ways of thinking about resultant policy challenges are developed. At the heart of this latest work by John Braithwaite lies the insight by David Levi-Faur and Jacint Jordana that the welfare state was succeeded in the 1970s by regulatory capitalism. The book argues that this has produced stronger markets, public regulation, private regulation and hybrid private/public regulation as well as new challenges such as a more cyclical quality to crises of market and governance failure, regulatory ritualism and markets in vice. However, regulatory capitalism also creates opportunities for better design of markets in virtue such as markets in continuous improvement, privatized enforcement of regulation, open source business models, regulatory pyramids with networked escalation and meta-governance of justice. Regulatory Capitalism will be warmly welcomed by regulatory scholars in political science, sociology, history, economics, business schools and law schools as well as regulatory bureaucrats, policy thinkers in government and law and society scholars.
Download or read book Basic Economics written by Thomas Sowell and published by Basic Books. This book was released on 2014-12-02 with total page 990 pages. Available in PDF, EPUB and Kindle. Book excerpt: The bestselling citizen's guide to economics Basic Economics is a citizen's guide to economics, written for those who want to understand how the economy works but have no interest in jargon or equations. Bestselling economist Thomas Sowell explains the general principles underlying different economic systems: capitalist, socialist, feudal, and so on. In readable language, he shows how to critique economic policies in terms of the incentives they create, rather than the goals they proclaim. With clear explanations of the entire field, from rent control and the rise and fall of businesses to the international balance of payments, this is the first book for anyone who wishes to understand how the economy functions. This fifth edition includes a new chapter explaining the reasons for large differences of wealth and income between nations. Drawing on lively examples from around the world and from centuries of history, Sowell explains basic economic principles for the general public in plain English.
Download or read book Essentials of Nursing Leadership and Management written by Ruth M. Tappen and published by F A Davis Company. This book was released on 2004-01 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition focuses on preparing your students to assume the role as a significant member of the health-care team and manager of care, and is designed to help your students transition to professional nursing practice. Developed as a user-friendly text, the content and style makes it a great tool for your students in or out of the classroom. (Midwest).
Download or read book PAREXEL s Pharmaceutical R D Statistical Sourcebook written by and published by . This book was released on 2001 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook on Nuclear Law written by Carlton Stoiber and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a practical aid to legislative drafting that brings together, for the first time, model texts of provisions covering all aspects of nuclear law in a consolidated form. Organized along the same lines as the Handbook on Nuclear Law, published by the IAEA in 2003, and containing updated material on new legal developments, this publication represents an important companion resource for the development of new or revised nuclear legislation, as well as for instruction in the fundamentals of nuclear law. It will be particularly useful for those Member States embarking on new or expanding existing nuclear programmes.
