International IT Regulations and Compliance

International IT Regulations and Compliance
Author: Siri H. Segalstad
Publisher: John Wiley & Sons
Total Pages: 338
Release: 2008-11-20
Genre: Law
ISBN: 9780470721834

Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.

Co-operative Compliance and the OECD’s International Compliance Assurance Programme

Co-operative Compliance and the OECD’s International Compliance Assurance Programme
Author: Ronald Hein
Publisher: Kluwer Law International B.V.
Total Pages: 314
Release: 2020-06-10
Genre: Law
ISBN: 9403519800

Prominent among initiatives addressing the urgent need for a common understanding between multinational enterprises (MNEs) and national tax authorities about risks and risk assessment is the International Compliance Assurance Programme (ICAP), which provides a channel for MNEs to engage in simultaneous discussions with multiple national tax administrations, thus enhancing the potential for advance tax assurance. To a certain extent, the ICAP represents the internationalization of Co-operative Compliance frameworks which were, until then, restricted within the borders of single jurisdictions. This book is the first to investigate Co-operative Compliance alongside with the ICAP, describing developments in twelve countries (Australia, Austria, Canada, Germany, Italy, Japan, the Netherlands, Norway, Poland, Spain, the United Kingdom, and the United States). Following a general introduction, two opening perspectives on the ICAP are presented, one from the OECD and one from a participating tax administration (the Netherlands), leading to the twelve country reports and a special chapter on transfer pricing, which is the main issue in international tax disputes. Specific elements reviewed include the following: criteria to enter the programme; the range of taxes covered by the programme; real-time consultation procedures; appeal procedures within the programme; the possibility to ‘agree to disagree’ and to continue Co-operative Compliance even in cases of litigation; risk management strategies within tax authorities; corporate administrative compliance burden; and main sources of tax uncertainty. Country reports are contributed by tax professionals and tax academics experienced in dealing with Co-operative Compliance and the ICAP. Each report addresses the same questions, so that all the reports cover the same features of domestic relationship approaches and the ICAP. A final chapter reviews the collected contributions and offers some concluding remarks. Although the ICAP process probably will undergo further adjustments, it is certain that the road to more international cooperation between tax authorities and MNEs is now open. This timely book, as a comparative review of the implementation of the ICAP among leading jurisdictions active in global trade, provides matchless insights into trends, similarities, differences and their implications. It will be welcomed by all stakeholders in the international tax community, including lawyers, taxation authorities and academics.

Theories of Compliance with International Law

Theories of Compliance with International Law
Author: Mark G. Burgstaller
Publisher: BRILL
Total Pages: 242
Release: 2004-11-26
Genre: Law
ISBN: 9047406761

This book examines some of the most prominent contemporary theories of compliance with international law. It is argued that these theories ultimately rely on some political philosophy and that therefore their strengths and weaknesses can be traced back to those of the respective philosophical background. The approach finally taken is based on some recent empirical and theoretical research undertaken and as such provides new insights to the major works of the authors that are at the core of the discussion.

21 CFR Part 11

21 CFR Part 11
Author: Orlando López
Publisher: CRC Press
Total Pages: 287
Release: 2004-01-15
Genre: Medical
ISBN: 1135488754

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places

Improving Compliance with International Law

Improving Compliance with International Law
Author: Roger Fisher
Publisher:
Total Pages: 392
Release: 1981
Genre: Law
ISBN:

Monograph on law enforcement of national level compliance with international law - considers conventional law enforcement theory based on sanctions as a means of international dispute settlement and encouraging compliance but suggests international agreements and treatys, reciprocal reaction to noncompliance, enlightened self- interest and integration of international law into national legislation are more effective, and looks at the role of international organizations and international and domestic courts. References.

Regulatory Compliance

Regulatory Compliance
Author: Dennis Campbell
Publisher: Kluwer Law International
Total Pages: 0
Release: 2019
Genre: Commercial law
ISBN: 9789403510750

The core legal concepts underlying compliance and their impact on business operations encompass corporate governance, cyberlaw and security, financial services regulations, and compliance issues in health care and biotechnology. "Compliance", a term often invoked but subject to a variety of iterations. To engage in compliance services, lawyers must have a good knowledge of the regulated industry that they serve, an understanding of risk management, and the skills to draft policy statements, provide financial reporting, and advise in the development of projects. In this edition of the Comparative Law Yearbook of International Business, lawyers from nine jurisdictions examine recent developments in their respective countries pertaining to compliance issues. Chapters are provided by practitioners from Argentina, India, Nigeria, Poland, Portugal, Switzerland, Thailand, the United Kingdom, and the United States. The publication also includes two appendices: General Assembly Resolution 58/4 of 31 October 2003, United Nations Convention against Corruption, and General Assembly Resolution 55/25 of 15 November 2000, United Nations Convention against Transnational Organized Crime.

Research Handbook on Compliance in International Human Rights Law

Research Handbook on Compliance in International Human Rights Law
Author: Grote, Rainer
Publisher: Edward Elgar Publishing
Total Pages: 576
Release: 2021-10-21
Genre: Political Science
ISBN: 1788971124

This comprehensive Research Handbook offers an in-depth examination of the most significant factors affecting compliance with international human rights law, which has emerged as one of the key problems in the efforts to promote effective protection of human rights. In particular, it examines the relationships between regional human rights courts and domestic actors and judiciaries.

Cooperative Compliance

Cooperative Compliance
Author: Jeffrey Owens
Publisher: Kluwer Law International B.V.
Total Pages: 152
Release: 2021-08-18
Genre: Law
ISBN: 9403531940

National taxation authorities around the world are rapidly improving international cooperation, given the unprecedented triple impact of persistent revelations of large-scale corporate tax avoidance, the ever-increasing intricacies of digital cross-border transactions, and the unprecedented revenue deficits engendered by the COVID-19 pandemic. There is also a growing recognition that improving tax compliance needs to be reconciled with a legitimate desire on the part of businesses to have some certainty about their taxes. Cooperative compliance is one way to achieve that. This first analysis of the details of cooperative compliance programmes currently in operation describes tax control frameworks, suggests practical examples to assist practitioners in tax administrations and the private sector, and provides multiple perspectives on the design and legitimacy of such programmes. Drawing on detailed information contributed by tax practitioners and academics from a wide range of jurisdictions worldwide, the book identifies and explains certain crucial elements of successful programmes: the criteria for access to cooperative compliance (e.g., is the programme voluntary or mandatory? Is there a financial threshold? Will the criteria be publicly available?); model legislation that can facilitate the operation of such programmes (statutory provisions, administrative rules and procedures, etc.); the foundations for an international agreement on an audit assurance standard for tax control frameworks (including the role of the Organisation for Economic Co-operation and Development (OECD), the European Union (EU), and other international organizations); how to develop a methodology to measure the cost and benefits of cooperative compliance programmes; detailed case studies of existing compliance programmes in Australia, Austria, China, Germany, Italy, Poland, and Russia; and how to communicate a cooperative compliance programme to obtain trust from society. The analysis draws on two years of work led by WU Global Tax Policy Center (GTPC) at Vienna University of Economics and Business in cooperation with the International Chamber of Commerce (ICC) and the Commonwealth Association of Tax Administrators (CATA). The project brought together over two hundred people from 25 countries, including public officials, businesses, and academics. Tax certainty and predictability are key components for providing a tax environment that is conducive to cross-border trade and investment, and, in the long term, it is in the interest of both governments and businesses to minimize tax uncertainty as much as possible. This truly helpful book promises to pave the way to an internationally effective tax framework that will be welcomed by taxation authorities and practitioners worldwide.

The Cambridge Handbook of Compliance

The Cambridge Handbook of Compliance
Author: Benjamin van Rooij
Publisher: Cambridge University Press
Total Pages: 1559
Release: 2021-05-20
Genre: Law
ISBN: 1108754139

Compliance has become key to our contemporary markets, societies, and modes of governance across a variety of public and private domains. While this has stimulated a rich body of empirical and practical expertise on compliance, thus far, there has been no comprehensive understanding of what compliance is or how it influences various fields and sectors. The academic knowledge of compliance has remained siloed along different disciplinary domains, regulatory and legal spheres, and mechanisms and interventions. This handbook bridges these divides to provide the first one-stop overview of what compliance is, how we can best study it, and the core mechanisms that shape it. Written by leading experts, chapters offer perspectives from across law, regulatory studies, management science, criminology, economics, sociology, and psychology. This volume is the definitive and comprehensive account of compliance.

Business Regulation and Public Policy

Business Regulation and Public Policy
Author: André Nijsen
Publisher: Springer Science & Business Media
Total Pages: 361
Release: 2008-12-03
Genre: Law
ISBN: 0387776788

For years, businesses have complained about the costs of regulatory compliance. On the other hand, society is becoming increasingly aware of the environmental, safety, health, financial, and other risks of business activity. Government oversight seems to be one of the answers to safeguard against these risks. But how can we deregulate and regulate without jeopardizing our public goals or acting as a brake on economic growth? Many instruments are available to assess the effects of laws regulating business, including the regulatory impact assessment (RIA), which contains cost/benefit analysis, cost-effectiveness analysis, risk analysis, and cost assessments. This book argues that public goals will be achieved more effectively if compliance costs of the enterprises are as low as possible. Highlighting examples from a wide spectrum of industries and countries, the authors propose a new kind of RIA, the business impact assessment (BIA), designed to improve both business and public policy decision making.