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Pharmacetical Applications In The European Union
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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 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 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 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 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 Pharmacetical Applications in the European Union by : Cheng Yee Lowe
Download or read book Pharmacetical Applications in the European Union written by Cheng Yee Lowe and published by CRC Press. This book was released on 1998-02-28 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the regulatory requirements and gives a clear understanding of how to achieve compliance. The author gathers all the relevant requirements, puts them into context, and provides regulatory information in an easily accessible format. Headings, subheadings, and key points organized in tabular format make the information easy for readers to find and the book easy for readers to use.
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 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 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 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 2007-11 with total page 54 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 Assuring the Quality of Health Care in the European Union by : Helena Legido-Quigley
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Book Synopsis Pharmaceutical Applications of Polymers for Drug Delivery by : David Jones
Download or read book Pharmaceutical Applications of Polymers for Drug Delivery written by David Jones and published by iSmithers Rapra Publishing. This book was released on 2004 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: Annotation The review focuses on the use of pharmaceutical polymer for controlled drug delivery applications. Examples of pharmaceutical polymers and the principles of controlled drug delivery are outlined and applications of polymers for controlled drug delivery are described. The field of controlled drug delivery is vast therefore this review aims to provide an overview of the applications of pharmaceutical polymers. The review is accompanied by approximately 250 abstracts taken from papers and books in the Rapra Polymer Library database, to facilitate further reading on this subject.
Book Synopsis Research and Development in the Pharmaceutical Industry (A CBO Study) by : Congressional Budget Office
Download or read book Research and Development in the Pharmaceutical Industry (A CBO Study) written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
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 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fully revised and updated, this practical book contains information on the processes, legislation, cases and customs that apply to the introduction, marketing and sale of a medicinal product (or medicinal device) in Europe. 00Pharmaceutical regulatory law is becoming ever more complicated, with the need to balance the constitutional requirements of the EU and its constituent Member States. This work, written by and for lawyers, will help you advise your clients on this constantly changing area. 00The new edition provides you with information on the changes to clinical trials, pharmacovigilance and competition law, helping you stay abreast of new legislation. 00Adopting 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, providing you with comprehensive and unambiguous guidance at every stage. 00Comprising three main sections, you’ll find the mainstream medicinal products from cradle to grave; specific regimes which do not fall into those categories; and three standalone chapters, dealing with an overview of what a medical device is, parallel trade, and competition law. 00Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of 15 incisive chapters examines a particular process or subject.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498635 Total Pages :169 pages Book Rating :4.3/5 (94 download)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Book Synopsis Health Policy and European Union Enlargement by : Mckee
Download or read book Health Policy and European Union Enlargement written by Mckee and published by McGraw-Hill Education (UK). This book was released on 2004-04-01 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy.
Book Synopsis Reviewing Current Practice in Drug-substitution Treatment in the European Union by : European Monitoring Centre for Drugs and Drug Addiction
Download or read book Reviewing Current Practice in Drug-substitution Treatment in the European Union written by European Monitoring Centre for Drugs and Drug Addiction and published by . This book was released on 2000 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of the European Monitoring Centre for Drugs and Drug Addiction is to provide objective, reliable and comparable information about drugs and drug addiction in Europe. This study looks at the use of substitution treatments. It concludes that there has been a steady increase in the use of such treatments but that a successful strategy requires a multiple approach that combines drug substitution with drug free treatments. As well as an overview of the subject, this book provides reports on the situation in each of the EU countries.
