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Pharmaceuticals In The European Union
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Book Synopsis Pharmaceuticals in the European Union by : Giuditta Savonitto
Download or read book Pharmaceuticals in the European Union written by Giuditta Savonitto and published by Cambridge Scholars Publishing. This book was released on 2019-04-23 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers the first complete and up-to-date analysis of the European Union’s regulation of medicines. Through a reasoned description ranging from regulatory developments to the jurisprudence of the Court of Justice of the European Union, it delineates the current European pharmaceutical regulation system. Moreover, the economic and social implications caused by the market fragmentation linked to disparities in national pricing and reimbursement schemes of pharmaceuticals are also explored here. In what was theorized to be a patchwork of rules and roles, the potential growth of the pharmaceutical industry is hampered and important inequalities in patient access are growing. What will be the next moves of European Union legislation to address the aging of the population, the higher incidence of some diseases and the growing costs of innovative medicines? Answers to such questions are offered in this book.
Book Synopsis Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality by : Mossialos, Elias
Download or read book Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality written by Mossialos, Elias and published by McGraw-Hill Education (UK). This book was released on 2004-06-01 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in the EU. It is not just that this is a very up-to-date compendium of facts and data across a wide variety of domains that impact on pharmaceutical regulation. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. It is a must-read for those who seek to understand and navigate the changing regulatory environment for medicines in the European Union." Bernie O'Brien, McMaster University, Canada. The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care.Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. The editors: Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist (Europe and Central Asia region) for the World Bank and formerly a Research Officer in Health Economics for the European Observatory on Health Systems and Policies. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. Contributors:Julia Abelson, Christa Altenstetter, Vittorio Bertele’, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean-Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru', Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley.
Book Synopsis Civil Society and Health by : Scott L. Greer
Download or read book Civil Society and Health written by Scott L. Greer and published by World Health Organization. This book was released on 2017-11-20 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: Civil Society Organizations (CSOs) can make a vital contribution to public health and health systems but harnessing their potential is complex in a Europe where government-CSO relations vary so profoundly. This study is intended to outline some of the challenges and assist policy-makers in furthering their understanding of the part CSOs can play in tandem and alongside government. To this end it analyses existing evidence and draws on a set of seven thematic chapters and six mini case studies. They examine experiences from Austria Bosnia-Herzegovina Belgium Cyprus Finland Germany Malta the Netherlands Poland the Russian Federation Slovenia Turkey and the European Union and make use of a single assessment framework to understand the diverse contexts in which CSOs operate. The evidence shows that CSOs are ubiquitous varied and beneficial and the topics covered in this study reflect such diversity of aims and means: anti-tobacco advocacy food banks refugee health HIV/AIDS prevention and cure and social partnership. CSOs make a substantial contribution to public health and health systems with regards to policy development service delivery and governance. This includes evidence provision advocacy mobilization consensus building provision of medical services and of services related to the social determinants of health standard setting self-regulation and fostering social partnership. However in order to engage successfully with CSOs governments do need to make use of adequate tools and create contexts conducive to collaboration. To guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. This suggests identifying key CSOs in a given area; clarifying why there should be engagement with civil society; being realistic as to what CSOs can or will achieve; and an understanding of how CSOs can be helped to deliver.
Book Synopsis Pharmaceuticals in the European Union by : European Commission. Enterprise DG.
Download or read book Pharmaceuticals in the European Union written by European Commission. Enterprise DG. and published by . This book was released on 2000 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Health at a Glance: Europe 2020 State of Health in the EU Cycle by : OECD
Download or read book Health at a Glance: Europe 2020 State of Health in the EU Cycle written by OECD and published by OECD Publishing. This book was released on 2020-11-19 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2020 edition of Health at a Glance: Europe focuses on the impact of the COVID‐19 crisis. Chapter 1 provides an initial assessment of the resilience of European health systems to the COVID-19 pandemic and their ability to contain and respond to the worst pandemic in the past century.
Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Book Synopsis The Interplay of Global Standards and EU Pharmaceutical Regulation by : Sabrina Röttger-Wirtz
Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
Book Synopsis The Challenges of the New EU Pharmaceutical Legislation by : José Luis Valverde
Download or read book The Challenges of the New EU Pharmaceutical Legislation written by José Luis Valverde and published by IOS Press. This book was released on 2005 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge.
Book Synopsis EU Pharmaceutical Regulation by : Govin Permanand
Download or read book EU Pharmaceutical Regulation written by Govin Permanand and published by Manchester University Press. This book was released on 2006-09-05 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an analysis of European Union pharmaceutical regulation from a policy-making perspective. The focus is on how the often conflicting agendas of the pharmaceutical industry, the EU member states, the European Commission, and consumer interests are reconciled within the context of regulatory outcomes having to serve public health, healthcare and industrial policy needs within the single market. In providing a unique perspective on how and why EU pharmaceutical policy is made, the book will be of interest to academics, students and policy-practitioners interested in EU policy-making, regulation and public policy analysis.
Book Synopsis Guide to EU Pharmaceutical Regulatory Law by : Sally Shorthose
Download or read book Guide to EU Pharmaceutical Regulatory Law written by Sally Shorthose and published by . This book was released on 2010 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: This online version of this title will be shortly available atwww.kluwerlawonline.com.legislation, cases and customs which apply to the introduction, marketing andsale of a medicinal product (or a medical device) in Europe and to providesome clarity around the aforementioned complicated systems. It iswritten by and for lawyers, both in-house and in private practice, who findthemselves having to advise a client or clients on this ever-changing area oflaw, perhaps on the steps needed to bring a product to market including anysupplementary obligations (such as the need to conduct a clinical trial of theproduct for paediatric use), or perhaps when advising on clinical trialagreements, what “normal” rights and obligations of parties shouldbe included in the agreement. We hope the book will also be of interest andassistance to regulatory advisers. Each chapter presents a particularprocess or subject from a Europe-wide perspective. The chapters take thereader through the life of a medicinal product or medical device, fromdevelopment to clinical trials to product launch and afterwards, and weprovide guidance in matters where regulatory law is used as an instrument oflife-cycle management. With the exception of the advertising chapter,this book deals primarily with the European level of legislation. Where thereare significant national deviations or differences in interpretation, we havebeen able to take advantage of the breadth of Bird & Bird experience in anumber of major jurisdictions: ;UK, ;France, ;Germany, ;Spain, ;Belgium, ;TheNetherlands, ;Italy and ;Sweden tocreate national variations charts that appear at the end of certainchapters. These charts provide information on how the subject matter of thechapter is implemented in those eight major Member States, and they also serveto illustrate how implementation of the EU regulations varies between MemberStates. We have only included relevant or significant information so thelength of these appendices varies, and for some subjects, such as paediatrics,the legislation is so new and pan-European that we decided that no localvariation needed to be included. In addition, at the end of eachchapter we have included a list of guidelines/publications which will directthe readers to sources of additional information. European legislation ispeppered with acronyms. For help keeping them all straight, we included a listof the most commonly used ones in the pharmaceutical area, in addition tothose that appear in each chapter. This online version of this title will be shortly available atwww.kluwerlawonline.com.
Book Synopsis Pharmacovigilance in the European Union by : Michael Kaeding
Download or read book Pharmacovigilance in the European Union written by Michael Kaeding and published by Springer. This book was released on 2017-02-20 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level.
Book Synopsis Regulating Medicines in Europe by : John Abraham
Download or read book Regulating Medicines in Europe written by John Abraham and published by Routledge. This book was released on 2014-04-04 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.
Book Synopsis The European Union as a Global Health Actor by : Thea Emmerling
Download or read book The European Union as a Global Health Actor written by Thea Emmerling and published by World Scientific. This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic collection of EU actors, EU policy and EU actions in global health. It answers key questions on governance of the EU and its policy processes. The book starts with an introduction to the EU as a global actor and continues to outline the historical development and the Treaty basis for health, including the Maastricht and Lisbon Treaties. It also discusses the Commission's global health communication and the subsequent Council Conclusions on global health. Both documents define EU values in global health and identify the future priorities for global health action in the EU. Four of the five priorities are then described from the perspective of a different country experience. The book also considers the opportunities for research and provides an overview of the political, legal and financial instruments available to the EU. It also explores the global health architecture and processes within which the EU is acting, namely at the WHO, in the different multilateral organizations, and in global public health international treaties and regulations. Finally, the book addresses the importance of policy coherence at a national level and provides critical viewpoint on the EU as a global health actor. The book will assist practitioners working in policy making and international negotiations affecting health, as well as students and researchers, to create a better understanding of the European Union, its role in global health, and the uniqueness and specificity of the EU as a global health actor. It provides an overview of how the EU can act in global health and outlines the intersections of health and other sectors, as well as the instruments available to the EU to act effectively at a global level. The collection of contributions in this form and from this health policy perspective are not yet found elsewhere on the market.
Book Synopsis Research & Development of the european pharmaceutical industry by : Arne Noack
Download or read book Research & Development of the european pharmaceutical industry written by Arne Noack and published by GRIN Verlag. This book was released on 2004-03-14 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: Seminar paper from the year 2003 in the subject Business economics - Operations Research, grade: A, Vrije University Brussel (Vesalius College), course: Economics, language: English, abstract: The health of their population has always been a great concern for governments of Post-War Europe. In order to achieve their goals they had to work closely together with the pharmaceutical Industry. With the phenomenon of the aging population the importance of development of new drugs is increasing. The increasingly old population of Europe creates a big market for pharmaceutical companies. The pharmaceutical Industry is a very complex sector with close links to other Industries. The chemical Industry for example is an important supplier for materials needed in the process of creating new drugs. Furthermore is the market for pharmaceuticals characterized by extremely little concentration and a huge variety of products. Globally in 1998, the 300 best-selling products held a share of less than 45% of the worlds market. The top two products held 1.3% of the market each.1 This fact creates a necessity for the companies to research new, so called “Blockbuster drugs” to succeed on this market with a high competition. The data on the various methods of drug discovery is enormous and sophisticated. In this paper the structure of the Research & Development sector of the European pharmaceutical industry will be examined, which is of increasing importance for the success of the individual companies. The specific data on the R & D section will be given a general character. Furthermore it will give a brief overview of the different regions in Europe and their individual differences. In the end, the difficulties and challenges of R & D in the pharmaceutical industry will be described and compared to other pharma markets abroad. [1 Data taken from „Combining discovery with development” by Dr. Peter Eddershaw; World pharmaceutical frontiers 2003/2004 ]
Book Synopsis Guide to EU and UK Pharmaceutical Regulatory Law by : Sally Shorthose
Download or read book Guide to EU and UK Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2023-01-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Book Synopsis Health Governance in Europe by : Monika Steffen
Download or read book Health Governance in Europe written by Monika Steffen and published by Routledge. This book was released on 2005-11-28 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health constitutes a core element of welfare states and a vital nerve in the trust relation between citizen and their governments. Focusing on the health sector, this book analyzes the closely interwoven relationship between the European Union and Member States. The authors explore the dynamic and multi-fold process of de-nationalizing health policies and illustrate how European policies develop in a sector that still appears to be under exclusively national competence. They describe the multiple forms and ways the Europeanization process takes, driven by market integration, public health crises and politics of consumer protection. The authors also provide a detailed analysis of key topics: the pharmaceutical sector, market regulation of medical goods and devices, food safety, the blood provision and plasma industry, European politics on bioethics, and risk reduction in the field of drug abuse. Providing a comprehensive and informed assessment of the Europeanization process in the field of health policies, this book will be of interest to students and scholars of health, European integration and policy-making.
Book Synopsis European Union and Pharmaceutical Competitiveness by : Peter Shelby
Download or read book European Union and Pharmaceutical Competitiveness written by Peter Shelby and published by . This book was released on 2003 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
