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The Challenges Of The New Eu Pharmaceutical Legislation
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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 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 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 2021-09-23 with total page 251 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 Law of Competition and Trade in the Pharmaceutical Sector by : Pablo Figueroa
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
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 Advances in Pharma Business Management and Research by : Lars Schweizer
Download or read book Advances in Pharma Business Management and Research written by Lars Schweizer and published by Saint Philip Street Press. This book was released on 2020-10-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of master's theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Book Synopsis Private Law in the External Relations of the EU by : Marise Cremona
Download or read book Private Law in the External Relations of the EU written by Marise Cremona and published by Oxford University Press. This book was released on 2016-03-17 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: Private Law in the External Relations of the EU is an innovative study of the interactions between EU external relations law and private law, two unrelated fields of law, inverted if private law is understood as regulatory private law - the space where regulatory law intersects with private economic activity. Here the link between the Internal Market and the global market - and thereby international law - is much more prominent. In this book, key questions about the relationship between EU external relations law and private law are answered, including: in what ways might European private law act as a tool to achieve EU external policy objectives, particularly in regulatory fields? How might the quickly developing EU external competence over the procedural dimensions of private law, including private international law, impact on substantive law, both externally and internally? And how is the legal position of private parties affected by EU external relations? In asking these questions, this edited collection opens up a field of enquiry into the so far underexplored relationship between these two fields of law. In doing so, it addresses three different aspects of the relationship: (i) the evolution of the EU competence, (ii) the ways in which EU private law extends its reach beyond the boundaries of the internal market, and (iii) the ways in which the EU contributes to the formation of private regulation at the international level.
Book Synopsis European Law and New Health Technologies by : Mark L. Flear
Download or read book European Law and New Health Technologies written by Mark L. Flear and published by Oxford University Press. This book was released on 2013-03-14 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: New health technologies promise great things but they also pose significant challenges for governments, particularly around safety concerns, effectiveness, and value for money. This collection analyses the defining features of the relationship between EU law and new technologies, and the roles of risk, rights, ethics, and markets.
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 Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Book Synopsis Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by : OECD
Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Book Synopsis Key Issues in Pharmaceuticals Law by : José Luis Valverde
Download or read book Key Issues in Pharmaceuticals Law written by José Luis Valverde and published by IOS Press. This book was released on 2007 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The focus of Key Issues in Pharmaceuticals Law is on the ongoing achievement of an authentic world code for medicinal products - a so-called "Pharmacopoeia"--Through scientific technical harmonization. The legal dimension of medicinal products conditions the whole sector and it acquires a global dimension through the demand to protect people's health. Hence it is necessary to go forward to total harmonization of all its aspects. A global legal statute for medicinal products is justified by the very nature of the product, by its social control and the need for it to circulate freely, although limitations can be accepted, for reasons of solidarity with less favored populations. Awareness must arise that the challenge for healthcare is not going to find an adequate answer at the world level without a qualitative change in the world organization of the UN. The globalized world we live in demands reinforced continental solidarity, if we are to confront the common problems and bring about international order. A scientific technical code on the quality of medicinal products is essential for a statute on medicines. That code is the Pharmacopoeia."--Publisher.
Book Synopsis Equitable Access to High-Cost Pharmaceuticals by : Zaheer-Ud-Din Babar
Download or read book Equitable Access to High-Cost Pharmaceuticals written by Zaheer-Ud-Din Babar and published by Academic Press. This book was released on 2018-02-27 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs Incorporates existing guidelines and recommendations by international organizations Compares and contrasts how different countries fund and police high-cost drug access Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing Reviews novel pharmaceuticals of current research interest
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 Responsibilities in the Efficient Use of Medicinal Products by : José Luis Valverde
Download or read book Responsibilities in the Efficient Use of Medicinal Products written by José Luis Valverde and published by IOS Press. This book was released on 2006 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emphasis of this book is on the problem of the efficient use of medicinal products. It is known that this is a subject that is neither new nor unknown. Hundreds of articles have been, and will continue to be written about it. Yet it has not been resolved. The lines of consensus to tackle it have not even been defined, and there are many opinions about different aspects. What is needed is overall consideration and then to try to act on common agreed bases. But first the problem must be analysed, and so the book raises the problem in the form of a Forum. The different actors have to be heard, and the governments, too, of course, which express themselves through the legal system. We are far from providing an adequate response in any national legal system. The debate is still open, but society is waiting for replies from those who have responsibilities. There is no one right answer. Many actors are jointly responsible in this situation...
Download or read book 2050 written by José Luis Valverde and published by IOS Press. This book was released on 2007 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph brings together a number of important papers dealing with the medical, societal and demographic ramifications of fertility and is a very valuable contribution to the European debate on fertility. The very low fertility levels in several EU Member States are a matter of public concern. An increase in fertility will not by itself stop demographic ageing but can contribute to decelerating current demographic trends. It is therefore essential to understand better the reasons behind Europe's low fertility rates. The difficulty of reconciling private life with a professional career far too often compel women to postpone having a family or to have fewer children than they would desire. It follows that more and more couples reach an age where fertility problems become prevalent. Involuntary infertility is a serious medical condition with strong negative consequences on the wellbeing of the couples concerned and has a negative impact on demographic trends.
Book Synopsis Blood, Plasma, and Plasma Proteins by : José Luis Valverde
Download or read book Blood, Plasma, and Plasma Proteins written by José Luis Valverde and published by IOS Press. This book was released on 2006 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Labile blood products and plasma-derived products are very sensitive form a social viewpoint. Along with the challenges faced by all medicinal products there is an added challenge due to the lack of raw material and the social problems with regards to their acquisition. Obtaining them depends on blood and plasma donations, which are insufficient. Europeans as a whole fail to even cover 40 % of their needs in plasma for fractionation. The aspiration that all donations shall be voluntary, free and unpaid, is an altruistic objective, which reality, unfortunately, contradicts every day. Governments and all social Agencies should promote to the maximum its actions in order to achieve the greatest number of donation each day. Even from a humanitarian or ethical viewpoint nobody can deny a possible donor accepting incentives. This incentive discussion, plus the concept of self-sufficiency of countries and more are discussed in this volume.
