Download or read book La r glementation europ enne du m dicament face au Brexit written by Jérémy Demortière and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le 23 juin 2016, le peuple britannique a décidé de quitter l'Union européenne, mais cette date marque aussi le début de trois ans et demi de négociations et de discussions entre Londres et Bruxelles. En effet, ce n'est qu'en date du 31 janvier 2020 que le Royaume-Uni s'est retiré officiellement de l'Union européenne. Cette sortie a obligé l'Union européenne à changer sa règlementation dans de nombreux domaines et en particulier dans celui du médicament. La vie d'un médicament débutant par la mise en place d'essais précliniques puis cliniques, il est apparu alors intéressant d'appréhender l'impact réglementaire du Brexit, en se focalisant sur les seuls essais cliniques. Dans ce contexte, ô combien complexe, les autorités de santé européennes et nationales ont pris les devants pour faire face et gérer au mieux cette situation. La finalité est de réduire au maximum l'impact que pourrait engendrer le Brexit sur l'ensemble des règles mises en place concernant les essais cliniques ; et d'assurer la sécurité des patients.
Download or read book Experimentalist Governance in the European Union written by Charles F. Sabel and published by Oxford University Press on Demand. This book was released on 2010-02-25 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book brings together a distinguished interdisciplinary group of European and American scholars to analyze the core theoretical features of the EU's new experimentalist governance architecture and explore its empirical development across a series of key policy domains.
Download or read book Vulnerable written by Colleen M. Flood and published by University of Ottawa Press. This book was released on 2020-07-14 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt: The novel coronavirus SARS-CoV-2, which causes the disease known as COVID-19, has infected people in 212 countries so far and on every continent except Antarctica. Vast changes to our home lives, social interactions, government functioning and relations between countries have swept the world in a few months and are difficult to hold in one’s mind at one time. That is why a collaborative effort such as this edited, multidisciplinary collection is needed. This book confronts the vulnerabilities and interconnectedness made visible by the pandemic and its consequences, along with the legal, ethical and policy responses. These include vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices harm us all. Hopefully, COVID-19 will forces us to deeply reflect on how we govern and our policy priorities; to focus preparedness, precaution, and recovery to include all, not just some. Published in English with some chapters in French.
Download or read book Supplementary Protection Certificates SPC written by Marco Stief and published by . This book was released on 2015-07 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Financial Crisis Management and Democracy written by Bettina De Souza Guilherme and published by Springer Nature. This book was released on 2020-12-09 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book discusses financial crisis management and policy in Europe and Latin America, with a special focus on equity and democracy. Based on a three-year research project by the Jean Monnet Network, this volume takes an interdisciplinary, comparative approach, analyzing both the role and impact of the EU and regional organizations in Latin America on crisis management as well as the consequences of crisis on the process of European integration and on Latin America’s regionalism. The book begins with a theoretical introduction, exploring the effects of the paradigm change on economic policies in Europe and in Latin America and analyzing key systemic aspects of the unsustainability of the present economic system explaining the global crises and their interconnections. The following chapters are divided into sections. The second section explores aspects of regional governance and how the economic and financial crises were managed on a macro level in Europe and Latin America. The third and fourth sections use case studies to drill down to the impact of the crises at the national and regional levels, including the emergence of political polarization and rise in populism in both areas. The last section presents proposals for reform, including the transition from finance capitalism to a sustainable real capitalism in both regions and at the inter-regional level of EU-LAC relations.The volume concludes with an epilogue on financial crises, regionalism, and domestic adjustment by Loukas Tsoukalis, President of the Hellenic Foundation for European and Foreign Policy (ELIAMEP). Written by an international network of academics, practitioners and policy advisors, this volume will be of interest to researchers and students interested in macroeconomics, comparative regionalism, democracy, and financial crisis management as well as politicians, policy advisors, and members of national and regional organizations in the EU and Latin America.
Download or read book The Way to Keep Young written by Dorothy Quigley and published by . This book was released on 1897 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book The Economic Security of Business Transactions written by Professor Konrad Raczkowski and published by Chartridge Books Oxford. This book was released on 2013-10-15 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary ‘The Economic Security of Business Transactions’ covers such aspects as: management in the economic system; commercial risk in domestic and international transactions; an assessment of partners; unofficial economy and the state budget; economic security business; the role and importance of law in business. The book looks at the threats and risks arising from international trade and operating leading businesses, plus the role of the State. It examines the required new forms, methods and approaches for management. This has significant implications for the businesses concerned and the State’s role. ‘The Economic Security of Business Transactions’ includes coverage of internal company factors, tax evasion and tax avoidance; the book also looks at the level of involvement of the State (especially the EU’s Common Market). This leads to abuses and distortions in the area of the competitiveness of enterprises and countries’ competitiveness; it also changes the perception of contemporary economic security. This book is an attempt to point to the example of single countries, the European Community, and on a global scale – what is the efficiency of national economic systems and how the associated risks impact upon economic trade disorders. Key Features Contains contributions from some of the world’s leading researchers. Has an interdisciplinary character – based on economics, management and law. Shows and defines real threats and risks which occur in economic trade. The Authors Konrad Raczkowski is Professor of Management, who specializes in the unofficial economy, public finances and management in the economic system. He is a Director of Economic Institute in University of Social Sciences in Warsaw; he was Head of the Department of the Economic Security Management. Between 2003 and 2013 he worked in the finance department. He was also the advisor and consultant to governmental institutions, entrepreneurs and the European Anti-Fraud Office in Brussels (OLAF). He has qualifications as an internal auditor of integrated management systems. Professor Raczkowski is a member of British Academy of Management and since 2008 he has been an associate of the Institute for Security and Development Policy in Stockholm. Friedrich Schneider is Professor of Economics at the Department of Economics at the Johannes Kepler University of Linz in Austria. He is recognized as a leading authority in the field of studies on the shadow world economy. He has conducted research and lectures, among institutions such as the Universities of Yale, Princeton, Virginia, Stockholm, Zurich, Carnegie Mellon and Aarhus. In the years 1997-1999 he was the President of the Austrian Economic Association and in 2005-2008 the President of the German Economic Association. He has advised many governments, entrepreneurs and the European Commission. He is the author or co-author of hundreds of publications, including 62 books published in many languages. Professor Schneider’s research interests focus on the theory of economic policy, finance and the analysis of economic consequences of government intervention. Readership Scientists and researchers of national economy and unofficial economy; people experienced in the management (public and business); entrepreneurs; and students Contents PART I. SHADOW ECONOMY AND TAX EVASION CHAPTER 1 Size and development of the shadow economy and of tax evasion within Poland and of its neighbouring countries from 2003 to 2013: some new facts (Friedrich Schneider and Konrad Raczkowski) CHAPTER 2 How to curtail Poland’s shadow economy: the viewpoints of business and tax authorities (Bogdan Mróz and Mariusz Sokolek) CHAPTER 3 Shadow banking versus the shadow economy in Poland (Jan K. Solarz) CHAPTER 4 Why VAT carousel crime schemes are almost impossible to prosecute in Poland? (Czeslaw J_drzejek, Jacek Wi_ckowski, Maciej Nowak and Jaroslaw Bak) CHAPTER 5 The latest changes in the French tax evasion policy and its influence on economic and financial security (Urszula Zawadzka-Pak) PART II. ECONOMY AND BUSINESS TRANSACTIONS CHAPTER 6 The idea of homo oeconomicus and the role of culture in the economy (Marian Noga) CHAPTER 7 The implications of tax competition and "race to the bottom" for economic growth (Jolanta Szolno-Koguc and Malgorzata Twarowska) CHAPTER 8 Correct planning of budget revenue as an essential condition for secure business transactions (Eugeniusz Ruskowski) CHAPTER 9 The effects of public transfers on an economic system (Marta Postula) CHAPTER 10 The role of marketing information in the assessment of a contractor’s credibility in business negotiations (Bogdan Gregor and Magdalena Kalinska-Kula) CHAPTER 11 Implementation of the business counterintelligence branch in enterprise structure (Miroslaw Kwieci_ski and Krzysztof Passella) CHAPTER 12 Systematization of risk in internal and international markets (Katarzyna Zukrowska) CHAPTER 13 The role of the supreme audit office in tackling corruption and other types of organisational pathologies (Zbyslaw Dobrowolski) CHAPTER 14 Analysis of state bank guarantees offered to enterprises by national bank holdings and system solutions in selected countries (Dorota Ostrowska) CHAPTER 15 Common banking supervision within the financial safety net (Beata Domanska-Szaruga) CHAPTER 16 Crisis management in the global economy (Robert Dygas) PART III. MANAGEMENT AND ECONOMIC SECURITY CHAPTER 17 Business Process Management as a way to achieve national economic security (Piotr Senkus) CHAPTER 18 Collaborative networks as a basis for internal economic security in sustainable local governance. The case of Poland (Barbara Kozuch and Katarzyna Sienkiewicz-Malyjurek) CHAPTER 19 Changes in European foreign trade in the context of economic security (Agnieszka Glodowska) CHAPTER 20 The impact of non-military threats to economic security (Andrzej Limanski, Zbigniew Grzywna and Ireneusz Drabik)
Download or read book The Troubled Dream of Genetic Medicine written by Keith Wailoo and published by JHU Press. This book was released on 2006-05-29 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Winner of the History of Science category of the Professional and Scholarly Publishing Awards given by the Association of American Publishers Why do racial and ethnic controversies become attached, as they often do, to discussions of modern genetics? How do theories about genetic difference become entangled with political debates about cultural and group differences in America? Such issues are a conspicuous part of the histories of three hereditary diseases: Tay-Sachs, commonly identified with Jewish Americans; cystic fibrosis, often labeled a "Caucasian" disease; and sickle cell disease, widely associated with African Americans. In this captivating account, historians Keith Wailoo and Stephen Pemberton reveal how these diseases—fraught with ethnic and racial meanings for many Americans—became objects of biological fascination and crucibles of social debate. Peering behind the headlines of breakthrough treatments and coming cures, they tell a complex story: about different kinds of suffering and faith, about unequal access to the promises and perils of modern medicine, and about how Americans consume innovation and how they come to believe in, or resist, the notion of imminent medical breakthroughs. With Tay-Sachs, cystic fibrosis, and sickle cell disease as a powerful backdrop, the authors provide a glimpse into a diverse America where racial ideologies, cultural politics, and conflicting beliefs about the power of genetics shape disparate health care expectations and experiences.
Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).
Download or read book How China Loses written by Luke Patey and published by Oxford University Press, USA. This book was released on 2021 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tells the story of China's struggles to overcome new risks and endure the global backlash against its assertive reach. Combining on-the-ground reportage with analysis, Luke Patey argues that China's predatory economic agenda, headstrong diplomacy, and military expansion undermine its global ambitions to dominate the global economy and world affairs
Download or read book I Shall Not Die But Live written by Joost Hogenboom and published by Lulu.com. This book was released on 2013-05-04 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: After his divorce in 2007 Joost Hogenboom embarked on a journey that would lead him into a new phase in his life. In this book he explains how prisoners, on death row and in prison, showed him a world he had not seen in a long time. His newfound friendships transformed him from a cold, materialistic, person to a man with a new and charitable outlook on life. In this book Joost takes the reader along on his journey. He describes parts of his youth and upbringing, his true friendships with hardened criminals and his new contacts with people around the globe. His writing is brutally honest, revealing, passionate, funny, sad and at times depressing. Although his friendships continue to evolve, he gives the reader an glimpse of his inspirational journey so far. Hold on to the dashboard and prepare yourself for a adventurous ride!
Download or read book Forms of Power written by Gianfranco Poggi and published by John Wiley & Sons. This book was released on 2013-07-08 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Political power is often viewed as the sole embodiment of 'social power', even while we recognize that social power manifests itself in different forms and institutional spheres. This new book by Gianfranco Poggi suggests that the three principal forms of social power - the economic, the normative/ideological and the political - are based on a group's privileged access to and control over different resources. Against this general background, Poggi shows how various embodiments of normative/ideological and economic power have both made claims on political power (considered chiefly as it is embodied in the state) and responded in turn to the latter's attempt to control or to instrumentalize them. The embodiment of ideological power in religion and in modern intellectual elites is examined in the context of their relations to the state. Poggi also explores both the demands laid upon the state by the business elite and the impact of the state's fiscal policies on the economic sphere. The final chapter considers the relationship between a state's political class and its military elite, which tends to use the resource of organized coercion for its own ends. Forms of Power will be of interest to students and scholars of sociology and politics.
Download or read book Redress Schemes for Personal Injuries written by Sonia Macleod and published by Bloomsbury Publishing. This book was released on 2017-11-30 with total page 731 pages. Available in PDF, EPUB and Kindle. Book excerpt: This ground-breaking book takes a fresh look at potential non-litigation solutions to providing personal injury compensation. It is the first systematic comparative study of such a large number – over forty – of personal injury compensation schemes. It covers the drivers for their creation, the frameworks under which they operate, the criteria and thresholds used, the compensation offered, the claims process, statistics on throughput and costs, and analysis of financial costings. It also considers and compares the successes and failings of these schemes. Many different types of redress providers are studied. These include the comprehensive no-blame coverage offered by the New Zealand Accident Compensation Corporation; the widely used Patient, Pharmaceutical, Motor Accident and Workers Compensation Insurance systems of the Nordic states; the far smaller issue-focused schemes like the UK Thalidomide and vCJD Trusts; vaccine damage schemes that exist in many countries; as well as motor vehicle schemes from the USA. Conclusions are drawn about the functions, essential requirements, architecture, scope, operation and performance of personal injury compensation systems. The relationships between such schemes, the courts and regulators are also discussed, and both calls and need for reforms are noted. Noting the wide calls for reform of NHS medical negligence litigation within the UK, and its replacement with a no blame approach, the authors' findings outline options for future policy in this area. This major contribution builds on general shifts from courts to ADR, and from blame to no blame in regulation, and is a work that has the potential to have a major impact on the field of personal injury redress. With contributions by Raymond Byrne, Claire Bright, Shuna Mason, Magdalena Tulibacka, Matti Urho, Mary Walker and Herbert Woopen.
Download or read book Drug Truths written by John L. LaMattina and published by John Wiley & Sons. This book was released on 2012-03-02 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.
Download or read book Injunctions in Patent Law written by Jorge L. Contreras and published by Cambridge University Press. This book was released on 2022-05-12 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains how the tailoring of injunctions in patent law works in Europe, the United States, Canada, and Israel.
Download or read book Territory and Power in the United Kingdom written by Jim Bulpitt and published by Manchester University Press. This book was released on 1983 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Territory and Power in the United Kingdom is about the nature of the UK state, where it came from and where it is going. Bulpitt sought to summarise the political code and statecraft that has helped govern the territories of the United Kingdom for much of the twentieth century, though it had its antecedents many years before. He provides an account of its emergence, operation and decline, which summarises an important phase in the United Kingdom's history and marks out why the country stood out from its continental neighbours in terms of its territorial organisation and state tradition. This ECPR Classics edition includes a new introduction by Peter John placing this important, classic work in a current context.
