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.

This book provides detailed guidance for those responsible for designing and applying compliance regimes in companies.

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.

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.

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.

Digital or ‘virtual’ currencies pose significant challenges for government, financial and legal institutions because of their non-physical nature and their relative anonymity to physical currency. These attributes make this form of exchange extremely volatile and, at the same time, attractive to criminals. Many countries around the world have, therefore issued warnings against the use of digital currencies and have enacted laws to regulate and in some cases, restrict their use among members under their respective jurisdictions. Digital Currency: An International Legal and Regulatory Compliance Guide serves as a primer for both general and specialized readers, as well as business law and e-commerce teachers and students, to recognize and understand the extensive network of laws and regulations already in place around the world which have a profound impact on the creation, distribution and use of digital currency and blockchain technology. The book is also a compliance guide assisting legal practitioners in the fields of business, law, and technology to develop, implement, manage, and maintain strategies, policies, practices, and procedures to ensure that their activities involving digital currency and blockchain technology comply with a complex set of legal requirements in several jurisdictions. The book addresses both the complex set of existing laws that have a profound impact on digital currencies and blockchain technology, and the emerging new legal requirements directed specifically towards digital currency. Readers will understand the broad implications of laws and regulations on digital currency and blockchain development and its use, and will also be equipped with the knowledge to incorporate these effectively into their professional and personal endeavors. This entails maximizing the value of digital currency and blockchain technology while also minimizing their risk of adverse legal consequences. Additionally, policymakers seeking to enforce current legislations or wishing to draft appropriate new regulations in the digital currency and blockchain economy will also benefit from the information provided in this book.

Measures for regulating the behaviour of nation states in relation to the global environment have increasingly taken the form of international treaties and conventions. Many have argued that this has proved to be an ineffective way of halting unsustainable development, for the provisions of these agreements are either too weak or are flouted regularly by the parties concerned. This volume seeks to address the crucial question of how compliance with these agreements could be encouraged effectively without damaging the fragile political consensus that is emerging on environmental issues. With extensive use of case studies, Improving Compliance will make stimulating reading for all students and researchers working in this area, as well as for anyone concerned about the effectiveness of international environmental measures.