Summary of the 2008 Work Programme of the European Medicines Agency PDF Download
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Author:
Publisher:
ISBN: 9789291550487
Category :
Languages : en
Pages : 28
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Book Description
Author:
Publisher:
ISBN: 9789291550487
Category :
Languages : en
Pages : 28
Get Book Here
Book Description
Author:
Publisher:
ISBN: 9789291550463
Category :
Languages : en
Pages : 26
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Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 33
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Author:
Publisher:
ISBN: 9789291550449
Category :
Languages : en
Pages : 33
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Book Description
Author: Anthony C. Cartwright
Publisher: CRC Press
ISBN: 1420081837
Category : Medical
Languages : en
Pages : 804
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Book Description
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030949866X
Category : Medical
Languages : en
Pages : 169
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Book Description
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: Mianna Meskus
Publisher: Springer
ISBN: 1137469102
Category : Social Science
Languages : en
Pages : 243
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Book Description
This book explores the new ways in which biology is becoming technology. The revolutionary iPS cell technology has made it possible to turn human skin and blood cells into pluripotent stem cells, thus providing an unprecedented opportunity to study the pathophysiology of diseases, understand human developmental biology, and generate new therapies. Drawing from a rich ethnographic study, Meskus traces the making of the iPS cell technology through the perspectives of clinical translation, laboratory experimentation, and tissue donation by voluntary patients. Discussing non-human agency, the embodied and affective basis of knowledge production, and the material politics of science, the book develops the idea of an instrumentality-care continuum as a fundamental dynamic of biomedical craft. This continuum, Meskus argues, opens up a novel perspective to the commercialization and industrial-scale appropriation of human biology, and thereby to the future of ethical biomedical research.
Author: Kevin Woodward
Publisher: John Wiley & Sons
ISBN: 9781444322941
Category : Medical
Languages : en
Pages : 776
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Book Description
Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.
Author: Anniek de Ruijter
Publisher: Oxford University Press
ISBN: 0191092150
Category : Law
Languages : en
Pages : 257
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Book Description
Whether there is a public health need for the containment and response to swine flu, or an individual need to access health care across the border for a hip operation to alleviate pain, the EU has an increasingly powerful role in the field of human health. Health law and policy is deeply tied into fundamental rights, bioethics and values, with important implications for individuals. However, it is also an expansive area of economic regulation, of social and state arrangements. The growing role of the EU in human health law and policy is contested, particularly as it has implications for the fundamental rights and values that are enshrined in national health law and policy. This book outlines, through case studies, how the expansion of EU power is taking place through law and policy, in both public health and health care. How is law and policy in the field of human health adopted, who are the institutional actors involved, and what is the impact of these developments for fundamental rights?
Author: Helena Legido-Quigley
Publisher: World Health Organization
ISBN: 9289071931
Category : Medical
Languages : en
Pages : 242
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Book Description
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.
