The Challenges Of The New Eu Pharmaceutical Legislation PDF Download
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| Author | : José Luis Valverde |
| Publisher | : IOS Press |
| Total Pages | : 154 |
| Release | : 2005 |
| Genre | : Business & Economics |
| ISBN | : 9781586035211 |
Download The Challenges of the New EU Pharmaceutical Legislation Book in PDF, ePub and Kindle
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.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 169 |
| Release | : 2020-04-25 |
| Genre | : Medical |
| ISBN | : 0309498635 |
Download Regulating Medicines in a Globalized World Book in PDF, ePub and Kindle
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.
| Author | : OECD |
| Publisher | : OECD Publishing |
| Total Pages | : 447 |
| Release | : 2019-10-17 |
| Genre | : |
| ISBN | : 9264805907 |
Download Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies Book in PDF, ePub and Kindle
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.
| Author | : Marise Cremona |
| Publisher | : Oxford University Press |
| Total Pages | : 369 |
| Release | : 2016-03-17 |
| Genre | : Law |
| ISBN | : 0191062014 |
Download Private Law in the External Relations of the EU Book in PDF, ePub and Kindle
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.
| Author | : Helena Legido-Quigley |
| Publisher | : World Health Organization |
| Total Pages | : 242 |
| Release | : 2008 |
| Genre | : Medical |
| ISBN | : 9289071931 |
Download Assuring the Quality of Health Care in the European Union Book in PDF, ePub and Kindle
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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 318 |
| Release | : 2011-10-25 |
| Genre | : Medical |
| ISBN | : 0309212456 |
Download Medical Devices and the Public's Health Book in PDF, ePub and Kindle
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.
| Author | : José Luis Valverde |
| Publisher | : IOS Press |
| Total Pages | : 176 |
| Release | : 2007 |
| Genre | : Law |
| ISBN | : 9781586038403 |
Download Key Issues in Pharmaceuticals Law Book in PDF, ePub and Kindle
"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.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 225 |
| Release | : 1991-02-01 |
| Genre | : Medical |
| ISBN | : 030904491X |
Download The Changing Economics of Medical Technology Book in PDF, ePub and Kindle
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.
| Author | : José Luis Valverde |
| Publisher | : IOS Press |
| Total Pages | : 158 |
| Release | : 2006 |
| Genre | : Drugs |
| ISBN | : 9781586036683 |
Download Responsibilities in the Efficient Use of Medicinal Products Book in PDF, ePub and Kindle
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...
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 141 |
| Release | : 2010-10-04 |
| Genre | : Medical |
| ISBN | : 0309162904 |
Download Public Health Effectiveness of the FDA 510(k) Clearance Process Book in PDF, ePub and Kindle
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.
