Pharmacovigilance In The European Union
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Pharmacovigilance In The European Union
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Author : Michael Kaeding
language : en
Publisher: Springer
Release Date : 2017-02-20
Pharmacovigilance In The European Union written by Michael Kaeding and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-20 with Political Science categories.
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.
Pharmacovigilance In The European Union
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Author : Michael Kaeding
language : en
Publisher:
Release Date : 2020-10-08
Pharmacovigilance In The European Union written by Michael Kaeding and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10-08 with Political Science categories.
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. 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.
The Cellular Automaton Interpretation Of Quantum Mechanics
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Author : Gerard 't Hooft
language : en
Publisher: Springer
Release Date : 2016-09-13
The Cellular Automaton Interpretation Of Quantum Mechanics written by Gerard 't Hooft and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-13 with Science categories.
This book presents the deterministic view of quantum mechanics developed by Nobel Laureate Gerard 't Hooft. Dissatisfied with the uncomfortable gaps in the way conventional quantum mechanics meshes with the classical world, 't Hooft has revived the old hidden variable ideas, but now in a much more systematic way than usual. In this, quantum mechanics is viewed as a tool rather than a theory. The author gives examples of models that are classical in essence, but can be analysed by the use of quantum techniques, and argues that even the Standard Model, together with gravitational interactions, might be viewed as a quantum mechanical approach to analysing a system that could be classical at its core. He shows how this approach, even though it is based on hidden variables, can be plausibly reconciled with Bell's theorem, and how the usual objections voiced against the idea of ‘superdeterminism' can be overcome, at least in principle. This framework elegantly explains - and automatically cures - the problems of the wave function collapse and the measurement problem. Even the existence of an “arrow of time" can perhaps be explained in a more elegant way than usual. As well as reviewing the author’s earlier work in the field, the book also contains many new observations and calculations. It provides stimulating reading for all physicists working on the foundations of quantum theory.
Regulatory Toxicology In The European Union
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Author : Tim Marrs
language : en
Publisher: Royal Society of Chemistry
Release Date : 2018-02-26
Regulatory Toxicology In The European Union written by Tim Marrs and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-02-26 with Medical categories.
Consumer and environmental protection depend on the careful regulation of all classes of chemicals. Toxicology is the key science used to evaluate safety and so underpins regulatory decisions on chemicals. With the growing body of EU legislation involved in chemical regulation, there is a concomitant need to understand the toxicological principles underlying safety assessments. Regulatory Toxicology in the European Union is the first book to cover regulatory toxicology specifically in Europe. It addresses the need for a wider understanding of the principles of regulatory toxicology and their application and presents the relationship between toxicology and legislative processes in regulating chemical commodities across Europe. This title has a broad scope, covering historical and current chemical regulation in Europe, the role of European agencies and institutions, and also the use of toxicology data for important classes of chemicals, including human and veterinary medicines, animal feed and food additives, biocides, pesticides and nanomaterials. This book is therefore extremely pertinent and timely in the toxicology field at present. This book is an essential reference for regulatory authorities, industrialists, academics, undergraduates and postgraduates working within safety and hazards, toxicology, the biological sciences, and the medicinal and pharmaceutical sciences across the European Union.
Guide To Eu Pharmaceutical Regulatory Law
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Author : Sally Shorthose
language : en
Publisher: Aspen Publishers
Release Date : 2014
Guide To Eu Pharmaceutical Regulatory Law written by Sally Shorthose and has been published by Aspen Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Drugs categories.
In the European Union and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but 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.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 fifteen incisive chapters examines a particular process or subject.
Pharmaceuticals In The European Union
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Author : European Commission. Enterprise DG.
language : en
Publisher:
Release Date : 2000
Pharmaceuticals In The European Union written by European Commission. Enterprise DG. and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Drugs categories.
Medical Devices
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Author : Christa Altenstetter
language : en
Publisher: Routledge
Release Date : 2017-09-08
Medical Devices written by Christa Altenstetter and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-08 with Medical categories.
Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents.
Regulating Medicines In Europe
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Author : John Abraham
language : en
Publisher: Routledge
Release Date : 2014-04-04
Regulating Medicines In Europe written by John Abraham and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-04 with Medical categories.
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.
European Medicines Research
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Author : G. N. Fracchia
language : en
Publisher: IOS Press
Release Date : 1994
European Medicines Research written by G. N. Fracchia and has been published by IOS Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Medical categories.
The European Medicines Evaluation Agency was established in 1995 in London on behalf of the European Union and regulates the standardization and harmonization in medicine applications for marketing authorization from 1995 on. The European Commission has been the driving force in the anticipation of international cooperation and research for harmonization standards. This volume provides an overview of contributions from academic, regulatory and pharmaceutical world on the current state, proposed methods and strategies for future research.
Assessment Of The European Community System Of Pharmacovigilance
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Author : Bernhard Bührlen
language : en
Publisher:
Release Date : 2006
Assessment Of The European Community System Of Pharmacovigilance written by Bernhard Bührlen and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with categories.
Medicines have adverse effects, but sometimes these are only identified when the product is already in use. Pharmacovigiliance, i.e. the monitoring of the safety of medicines and taking action to reduce risk and increase benefit, is therefore of tremendous importance. In the project "Assessment of the European Community System of Pharmacovigilance", which was funded by the European Commission, it was empirically studied how well the national medicines agencies, the European Medicines Agency and marketing authorisation holders collaborate to improve the safety of medicines. The book presents the methods and results of the study. Recommendations are made for the further development of the system.