"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed."

Introduces key terms, concepts, debates, and histories for Disability Studies Keywords for Disability Studies aims to broaden and define the conceptual framework of disability studies for readers and practitioners in the field and beyond. The volume engages some of the most pressing debates of our time, such as prenatal testing, euthanasia, accessibility in public transportation and the workplace, post-traumatic stress, and questions about the beginning and end of life. Each of the 60 essays in Keywords for Disability Studies focuses on a distinct critical concept, including "ethics," "medicalization," "performance," "reproduction," "identity," and "stigma," among others. Although the essays recognize that "disability" is often used as an umbrella term, the contributors to the volume avoid treating individual disabilities as keywords, and instead interrogate concepts that encompass different components of the social and bodily experience of disability. The essays approach disability as an embodied condition, a mutable historical phenomenon, and a social, political, and cultural identity. An invaluable resource for students and scholars alike, Keywords for Disability Studies brings the debates that have often remained internal to disability studies into a wider field of critical discourse, providing opportunities for fresh theoretical considerations of the field's core presuppositions through a variety of disciplinary perspectives. Visit keywords.nyupress.org for online essays, teaching resources, and more.

This book examines the powerful influence of civil law on understandings and responses to madness in England and in New Jersey. The influence of civil law on the history of madness has not hitherto been of major academic investigation. This body of law, established and developed over a five hundred year period, greatly influenced how those from England's propertied classes understood and responded to madness. Moreover, the civil law governing the response to madness in England was successfully exported into several of its colonies, including New Jersey. Drawing on a well-preserved and rare collection of trials in lunacy in New Jersey, this book reveals the important ties of civil law, local custom and perceptions of madness in transatlantic perspectives. This book will be highly relevant to scholars interested in law, medicine, psychiatry and madness studies, as well as contemporary issues in mental capacity and guardianship. -- .

In December 1995, the Court of Justice of the European Union delivered its judgment in its most famous case to date: the Bosman case. Twenty years later, this book explores in detail how this landmark judgment legally and politically transformed the relationship between the European Union and sport. Written by leading academics in the field, the ten contributions in this book reflect on how Bosman fundamentally shaped the application of EU law to sport and its transformative effects on sports governance. The book's innovative perspectives on the Bosman ruling makes it important reading for scholars, practitioners and policy-makers concerned with EU law and Sports law. With a foreword by Prof. Dr. Carl Otto Lenz, Advocate General at the Court of Justice in the Bosman-case. Dr. Antoine Duval is Senior Researcher for International and European Sports Law at the T.M.C. Asser Instituut in The Hague. He holds a Ph.D. on the interaction between Lex Sportiva and EU Law from the European University Institute in Florence, where he was the conveyor of the Transnational Law Working Group. Prof. dr. Ben Van Rompuy is a senior researcher at the T.M.C. Asser Instituut, where he heads the ASSER International Sports Law Centre, and is Visiting Professor of Competition Policy at the Free University of Brussels (VUB). He holds a Ph.D. in law from the VUB and held visiting scholar positions at Georgetown University and New York University. The book appears in the ASSER International Sports Law Series, under the editorship of Prof. Dr. Ben Van Rompuy, Dr. Antoine Duval and Marco van der Harst LL.M.

This book focuses on the legal and practical aspects of environmental finance and socially responsible business practices in Russia since the 1990s. Related publications to date tend to give a rather one-sided and negative picture. The authors in this book, however, provide a more positive and balanced outlook. Over half of them are from Russia, and most of the non-Russian authors have worked there extensively. As experts in their respective fields, they discuss a myriad of separate, but interrelated issues from an economic, legal or practical perspective. Topics include environmental law, pollution abatement, climate change and the Kyoto Protocol, renewable energy opportunities, NPAF, TACIS and EBRD projects, corporate social responsibility, environmental management systems, integration of EU environmental standards and adherence to the European Principles of Environmental Protection, environmental education and philanthropy. Giving a valuable introductory insight into the progress of environmental and socially responsible business practices in Russia, this book is essential reading for investors, academics, practitioners and those interested in sustainable development in Russia. Wybe Th. Douma, is a senior researcher in European Law and International Trade Law at the T.M.C. Asser Instituut. He worked in Russia on several projects, notably as senior legal expert for the first TACIS 'Harmonisation of environmental standards' project. Fiona M. Mucklow is a research associate at the T.M.C. Asser Instituut and an English solicitor with extensive expertise in finance law and international environmental law in Russia.

Understanding legal rules not as determinants of behavior but as points of reference for conduct, this volume considers the ways in which rules are invoked, referred to, interpreted, put forward or blurred. It also asks how both legal practitioners and lay participants conceive of and participate in the construction of facts and rules, and thus, through decisions, defenses, pleas, files, evidence, interviews and documents, actively participate in law's life. With attention to the formulation of notions such as person, evidence, intention, cause and responsibility in the course of legal practices, Legal Rules in Practice provides the outlines of a praxiological anthropology of law - an anthropology that focuses on words, concepts and reasoning as actively used to solve conflicts with the help of legal rules. As such, it will appeal to sociologists, anthropologists and scholars of law with interests in ethnomethodology, rule-based conduct and practical reasoning.

This book discusses the designs and applications of the social systems theory (built by Niklas Luhmann, 1927-1998) in relation to empirical socio-legal studies. This is a sociological and legal theory known for its highly complex and abstract conceptual apparatus. But how to change its scale in order to study more localised phenomena, and to deal with empirical data, such as case law, statutes, constitutions and regulation? This is the concern of a wide variety of scholars from many regions engaged in this volume. It focuses on methodological discussions and empirical examples concerning the innovations and potentials that functional and systemic approaches can bring to the study of legal phenomena (institutions building, argumentation and dispute-settlement), in the interface with economy and regulation, and with politics and public policies. It also discusses connections and contrasts with other jurisprudential approaches - for instance, with critical theory, law and economics, and traditional empirical research in law. Two decades after Luhmann's death, the 21st century has brought countless transformations in technologies and institutions. These changes, resulting in a hyper-connected, ultra-interactive world society bring operational and reflective challenges to the functional systems of law, politics and economy, to social movements and protests, and to major organisational systems, such as courts and enterprises, parliaments and public administration. Pursuing an empirical approach, this book details the variable forms by which systems construct their own structures and semantics and 'irritate' each other. Engaging Luhmann's theoretical apparatus with empirical research in law, this book will be of interest to students and researchers in the field of socio-legal studies, the sociology of law, legal history and jurisprudence.

This book addresses legal aspects of sustainable development and offers the latest thinking on a wide range of current themes. By taking a cross-cutting approach, it adds considerably to the exploration of this emerging scientific field. Twenty-nine original contributions present innovative thoughts and replicable ideas from this exciting, new area, which will be of value to practitioners and researchers alike.These contributions are allocated into a horizontal and sectorial part. The section covering horizontal policies has five sub-parts: 1) general aspects; 2) human and intellectual property rights; 3) communication and social enterprise governance; 4) public participation and 5) assessment tools. The second part on sectorial policies also has five sub-parts: 1) forest and water management; 2) renewable energy; 3) cities, waste and material management; 4) biodiversity, nature conservation, oceans and spatial planning and 5) agriculture and rural policy. It offers a multifaceted discussion of sustainable development and law by authors from five continents and from both the public and the private sectors. This selection guarantees a broad view that presents the more theoretical arguments from the academic as well as the practical perspective. Furthermore, the authorship includes senior, highly experienced academics and practitioners as well as those at the start of their career. This ensures thoughtful expansions of established theories as well as the emergence of innovative ideas. Moreover, the ten sub-parts bring together likeminded thoughts, resulting in an exchange of different viewpoints on a similar theme. This allows the readers to concentrate on individual chapters, while at the same time discovering a variety of thoughts and ideas.

This book investigates pesticide compliance in China in order to provide a more comprehensive understanding of compliance and offers some feasible and adaptable suggestions for enhancing the effectiveness of this compliance. It discusses the weak implementation of Chinese laws and rules and emphasizes the necessity and importance of a compliance perspective in China that focuses on why laws are obeyed or broken. It examines how vegetable farmers' perceptions of amoral calculation affect their pesticide compliance behavior and analyzes how the legitimacy of law is related to compliance to better explain how all the variables interact to shape compliance. It discusses both qualitative and quantitative methods, and uses a large-N qualitative approach, which allows for systematic analysis and in-depth exploration. This book will help readers to understand compliance in developing China by adopting and developing compliance theories which are broadly developed in the West.

"The Law on Age Discrimination in the EU" is edited by Malcolm Sargeant. The EC Directive establishing a general framework for equal treatment in employment and occupation covers a number of grounds of discrimination including age. The EU's population is ageing, but there is much evidence that age discrimination is widespread. The Directive is a reaction to that and the consequent desire to encourage greater participation in the labour market by older workers. This is the first time that age discrimination has been made unlawful by the EU and, as a result, there are now laws in every Member State making such discrimination unlawful. The Directive, and much of the national legislation, however, treats age discrimination differently to the other grounds for unlawful discrimination. It is the only area which permits direct discrimination. Age discrimination generally may still be objectively justified by a legitimate aim if the means of achieving that aim are appropriate and necessary. Such aims include legitimate employment policy, labour market, and vocational training objectives. This insightful book, written by national experts in eight Member States and at the EU level, considers the ways in which the Directive has been implemented in some of the Member States and the extent to which they have taken advantage of the exceptions that are inherent in the Directive. Particular issues that are covered are: what legislation has been adopted in each country; the development of the case law that exists in some States; the demographic imperative existing in each country; measures taken to improve the position of young people; retirement and the exit from the workforce of older workers; and, the approach and case law of the European Court of Justice. As an important contribution towards an understanding of age discrimination within the European Union, this book opens a field of law that has heretofore not been considered in all its seriousness. It will be of real value to lawyers, human resource management professionals, and those with an interest in discrimination and EU issues. It is an important contribution to what will be a developing field of study.

This book clarifies the meaning of the most important and pervasive concepts and tools in bioethical argumentation (principles, values, dignity, rights, duties, deliberation, prudence) and assesses the methodological suitability of the main methods for clinical decision-making and argumentation. The first part of the book is devoted to the most developed or promising approaches regarding bioethical argumentation, namely those based on principles, values and human rights. The authors then continue to deal with the contributions and shortcomings of these approaches and suggest further developments by means of substantive and procedural elements and concepts from practical philosophy, normative systems theory, theory of action, human rights and legal argumentation. Furthermore, new models of biomedical and health care decision-making, which overcome the aforementioned criticism and stress the relevance of the argumentative responsibility, are included.

This book expands on law-related research by comprehensively examining the legal aspects of sustainability with a focus on the impact on business strategies, investigating the impact of law and regulation on business sustainability strategies through a variety of legal lenses. It assumes that firms must adopt an integrated approach to law and sustainability, considers multiple disciplines and goals and joins scholarship from fields such as environmental law, energy, government regulation and intellectual property.

Firms increasingly have an interest in transitioning to sustainable business practices that take into consideration the fact that global resources are finite and will be increasingly scarce. They acknowledge that current actions have social, economic and environmental consequences and employ options to ensure that future generations have the same options and benefits.Examples of sustainable practices increasingly employed by firms include the institutionalization of whole life-cycle analysis in marketing and product design, utilization of sustainable inputs and energy sources, tracking and reporting sustainability performance, attempting the valuation of future generation prosperity and happiness as a discounting mechanism and integrating sustainability into firm culture and management goals.

It is clear that law and regulation have an extremely important role to play in the transition to more sustainable business practices. Broadly stated, law can provide structure for firms responding to forces that pull transition by enabling sustainability leadership and competitive advantage through funding models, intellectual property rights and collaboration means.Additionally, law can work to push transition by compelling firms to act through regulatory structures, accounting and governance mechanisms.Finally, coherent legal approaches are necessary to harmonize transition across countries by aligning and adapting goals to promote an equitable global marketplace that promotes development.

Representing a variety of areas and perspectives, the authors go beyond the existing legal literature to explore the impact of sustainability law on business practice and its implications for policy and future research."

This comprehensive, interdisciplinary collection, examines disability from a theoretical perspective, challenging views of disability that dominate mainstream thinking. Throughout, social theories of disability intersect with ideas associated with sex/gender, race/ethnicity, class and nation.

This book examines the relationship between law and scientific advancement, with a particular focus on the theory of evolution and medical innovation. Historically, the law has struggled to keep pace with modern medical advances. The authors demonstrate that the laws that govern human behaviour must evolve in response to such advances. This book describes how evolution shapes us humans and allows us to understand processes from ageing to decision making, and examines recent medical developments related to reproduction, neurosciences, sexuality, illness, bodily autonomy, and death, while considering the ethical, philosophical and legal implications of those developments.

Ecotoxiclogical risk from multiple stressors covers any situation where org- isms are exposed to a combination of environmental stressors. These include physical and chemical pollutants as well as other stressors such as parasites and environmental impact (e. g. , climate change or habitat loss). The combi- tion of stressors can result in increased risk to organisms (either additive or synergistic effects) or decreased effects (protective or antagonistic effects). The multiple stressor challenge is an international, multi-disciplinary problem requiring an international, multi-disciplinary approach. The c- rent approach to multiple stressors is to examine one stressor at a time and assume additivity. Little work has been done on combinations of stressors such that potential interactions can be determined. The problem is very complex. Multiple stressors pose a whole spectrum of challenges that range from basic science to regulation, policy and gove- ance. The challenges raise fundamental questions about our understanding of the basic biological response to stressors, as well as the implications of those uncertainties in environmental risk assessment and management. In addition to the great breadth, there is also great depth in the research ch- lenges, largely due to the complexity of the issues. From a basic science point of view, many of the mechanisms and processes under investigation are at the cutting edge of science - involving new paradigms such as genomic ins- bility and bystander effects.

The Antarctic is symbolic of the wider challenge facing the progressive development of the international legal order. How can the law ensure a balance between economic growth (and the attendant exploitation of natural resources) and environmental protection (requiring the wise and sustainable use of limited natural resources)? the contribution of science, of new institutional structures and of the non-governmental sector towards effective law-making, administrative and enforcement processes present a major challenge. This volume, inspired by a major symposium held in Brussels in October 1990, crystallizes the response of leading representatives of the legal, governmental, scientific and political communities and represents a significant new contribution to legal thought and practice, at a time when the international community has recognized the inadequacies of the international rules relating to the protection of natural resources and the environment.

Looks at effects of contemporary political and social system on psychology and psychotherapy * Puts forward ideas for advancing theory and clinical practice which counteract harmful effects of societal influences * Contains contributions from a distinguished international range of contributors

This book examines the law and its practice in the United Arab Emirates (UAE). The objective is to understand the logic of the legal system in the UAE through a rounded analysis of its laws in context. It thus presents an understanding of the system on its own terms beyond the accepted Western model. The book shows how the Emirati law differs from the conventional rule of law. The first section of the book deals with the imperial, international, and cultural background of the Emirati legal system and its influences on some of the elements of the legal system today. It maps the state's international legal obligations according to core human rights treaties showing how universal interpretations of rights may differ from Emirati interpretations of rights. This logic is further illustrated through an overview of the legal system, in federal, local, and free zones and how the UAE's diversity of legal sources from Islamic and colonial law provides legal adaptability. The second section of the book deals mainly with the contemporary system of the rule of law in the UAE but at times makes a detour to the British administration to show how imperial execution of power during the British administration created forerunners visible today. Finally, the debut of the UAE on the international scene contributed to an interest in human rights investigations, having manifestations in UAE law. The work will be a valuable resource for researchers and academics working in the areas of Comparative Constitutional Law, Legal Anthropology, Legal Pluralism, and Middle Eastern Studies.

Much has been written about the law as it affects new and minority religions, but relatively little has been written about how such religions react to the law. This book presents a wide variety of responses by minority religions to the legal environments within which they find themselves. An international panel of experts offer examples from North America, Europe and Asia demonstrating how religions with relatively little status may resort to violence or passive acceptance of the law; how they may change their beliefs or practices in order to be in compliance with the law; or how they may resort to the law itself in order to change their legal standing, sometimes by forging alliances with those with more power or authority to achieve their goals. The volume concludes by applying theoretical insights from sociological studies of law, religion and social movements to the variety of responses. The first systematic collection focussing on how minority religions respond to efforts at social control by various governmental agents, this book provides a vital reference for scholars of religion and the law, new religious movements, minority religions and the sociology of religion.

This publication characterizes the environmental burden of disease in the United Arab Emirates (UAE), measured by the excess number of deaths and illnesses in the population due to exposure to environmental hazards. The robust methods used in this risk analysis can be applied to any country or region. This publication documents the systematic, multi-step process used to identify environmental priorities and the detailed methods used to quantify the disease burden attributable to each risk. Based on the results of the burden of disease assessment, the publication summarizes the subsequent steps that are recommended to further reduce the burden of disease resulting from various environmental risk factors.

Authors and Contributors
This book represents the synthesis of research carried out by a large, interdisciplinary team from several institutions and multiple nations between June 2008 and June 2011.The lead authors are responsible for weaving together the pieces prepared by the team.Nonetheless, this book would not have been possible without major contributions from each team member.The list below shows contributors to each chapter.Following this list are biographies of all of the authors and contributors.

Lead Authors

Jacqueline MacDonald Gibson, Frederic J. P. Launay, Jens T. W. Thomsen, Angela Brammer, Christopher Davidson

Additional Contributors (by Chapter)

Chapter 2: Prioritizing Environmental Risks to Health
Henry H. Willis, Aimee Curtright, Gary Cecchine, Zeinab S. Farah, Sandra A. Geschwind, Jianhui Hu, Ying Li, Melinda Moore, Sarah Olmstead, Hanine Salem, Regina A. Shih, J. Jason West

Chapter 3: Assessing the Environmental Burden of Disease: Method Overview
TiinaFolley, Elizabeth S. Harder, MejsHasan

Chapter 4: Burden of Disease from Outdoor Air Pollution
Ying Li, GavinoPuggioni, PrahladJat, MejsHasan, Marc Serre, Kenneth G. Sexton, J. Jason West, SaravananArunachalam, Uma Shankar, William Vizuete, Mohammed ZuberFarooqui

Chapter 5: Burden of Disease from Indoor Air Pollution
Chris B. Trent

""

Chapter 6: Burden of Disease from Occupational Exposures
TiinaFolley, LeenaA. Nylander-French

Chapter 7: Burden of Disease from Climate Change
Richard N. L. Andrews, Leslie Chinery, Elizabeth S. Harder, J. Jason West

Chapter 8: Burden of Disease from Drinking Water Contamination
Gregory W. Characklis, Joseph N. LoBuglio

Chapter 9: Burden of Disease from Coastal Water Pollution
Gregory W. Characklis, Leigh-Anne H. Krometis, Joseph N. LoBuglio
Chapter 10: Burden of Disease from Soil and Groundwater Contamination
Chidsanuphong Chart-asa, Stephanie Soucheray-Grell

Chapter 11: Burden of Disease from Produce and Seafood Contamination
Leigh-Anne H. Krometis, Leslie Chinery"

This comprehensive Research Handbook is the first study to link law and Earth system science through the epistemic lens of the planetary boundaries framework. It critically examines the legal and governance aspects of the framework, considering not only each planetary boundary, but also a range of systemic issues, including the ability of law to keep us within the planetary boundaries' safe operating space. The expert contributors investigate the current and potential role of law in relation to the complex task and regulatory challenges of governing the Earth system. They explore three thematic areas: the overarching legal, ethical and governance dimensions of the planetary boundaries; their diverse international law dimensions and the challenges they raise for international law; and the extent to which the law already provides for some of the aspects illuminated by each planetary boundary, alongside opportunities for legal reform. Lawyers, Earth system scientists and governance experts will benefit from the mapping of the next stage of international environmental law included in the chapters. The book will also be a key resource for regulators, legislators and policy-makers looking for an in-depth study of the relationship between law and each of the nine planetary boundaries.

This handbook brings together a variety of approaches to the uses of big data in multiple fields, primarily science, medicine, and business. This single resource features contributions from researchers around the world from a variety of fields, where they share their findings and experience. This book is intended to help spur further innovation in big data. The research is presented in a way that allows readers, regardless of their field of study, to learn from how applications have proven successful and how similar applications could be used in their own field. Contributions stem from researchers in fields such as physics, biology, energy, healthcare, and business. The contributors also discuss important topics such as fraud detection, privacy implications, legal perspectives, and ethical handling of big data.

This work focuses specifically on environmental regulation of oil and gas. It contains in-depth articles on petroleum environmental regulation and management, written by well-known scholars, international lawyers and practitioners from around the world. The text deals with the environmental aspect of the hydrocarbon cycle in general and oil and gas exploration and production in particular, and its main thrust is management of environmental legal risks and issues in upstream operations. Part of the objective of the text is to introduce the best practices and legal tools of environmental management of petroleum exploration and production to the international oil community and other parties interested in the subject.

THE INSTANT NUMBER 1 SUNDAY TIMES BESTSELLER In this inspiring, uplifting and heart-warming memoir, world-renowned veterinary surgeon Professor Noel Fitzpatrick shares some of the most personal and powerful tales ever from his life as The Supervet. Picking up from where the Sunday Times bestselling How Animals Saved My Life left off, Noel shares the moving, heart-warming and often surprising stories of the animals that he has treated in his remarkable career. As he explores how our relationships with animals can bring out the best in each of us, we meet some of the wonderful animals he has tried to help, the families who love them and the deeply personal challenges Noel has faced along the way. It is animals like these who have taught Noel the valuable lessons of Love, Hope and Faith - lessons that have sustained him in his life beyond being the Supervet. This is the remarkable story of one man and the animals he has saved, animals who have - in turn - saved him.