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Lacces Au Marche Europeen Des Dispositifs Medicaux Combines
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Book Synopsis L'Accès au marché européen des dispositifs médicaux combinés by : Vlora Nishevci
Download or read book L'Accès au marché européen des dispositifs médicaux combinés written by Vlora Nishevci and published by . This book was released on 2014 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: La réglementation européenne, notamment la directive 93/42/CEE modifiée par la directive 2007/47/CE, prévoit la procédure d’enregistrement des dispositifs médicaux, notamment du dispositif médical combiné en Europe. C’est donc l’apposition du marquage CE qui permet l’accès au marché européen, et afin d’obtenir ce marquage, de nombreuse données, telles que le dossier technique, les normes applicables, le dossier de gestion des risques, sont exigées. Ces données doivent assurer la qualité, la sécurité et l’efficacité du produit. Seulement, ce marquage n’est pas toujours suffisant pour accéder au marché. En effet, le fabricant peut souhaiter le remboursement de son produit par les organismes de protection sociale. En comparant différents systèmes de remboursement et d’évaluation des prix des dispositifs médicaux de trois pays de l’Union Européenne, seront définis les critères permettant l’avis favorable des autorités de santé par un remboursement. C’est l’innovation présentée par le dispositif médical combiné qui assurera l’accès au marché européen.
Book Synopsis Dispositifs médicaux réglementation et accès au marché by : Elisa Roy-Cros
Download or read book Dispositifs médicaux réglementation et accès au marché written by Elisa Roy-Cros and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Le terme « Dispositif médical » désigne une grande diversité de produits, parfois très différents mais qui sont tous réunis par un cadre réglementaire commun : les directives « nouvelle approche ». Pour être mis sur le marché, à la disposition des utilisateurs finauxr un dispositif médical fait l'objet d'une procédure de marquage « CE » qui aboutit à l'apposition du sigle « CE » sur le produit, gage de conformité à la réglementation applicable. Le système des directives a récemment démontré ses failles en termes de sécurité des dispositifs pour les utilisateurs (exemple des prothèses PIP). C'est dans ce cadre que la Commission européenne a travaillé durant plusieurs années sur un projet de révision de la réglementation dans un objectif de renforcer les règles applicables aux dispositifs médicaux et harmoniser les pratiques a sein de l'Union européenne. Publié au Journal Officiel de l'Union Européenne le 5 avril 2017r le règlement no 2017/745 sera d'application obligatoire à compter du 26 mai 2020 et il est capital pour les fabricants d dispositifs médicaux d'analyser dès à présent les nouvelles exigences qui vont s'appliquer. En effet, les changements sont conséquents et on peut déjà identifier de nouvelles exigences que les opérateurs économiques vont devoir mettre en œuvre. Cette thèse a pour objet d'expliquer la démarche menant au marquage CE et d'identifier dans une deuxième partie les changements apportés par le règlement n o 2017/745, ayant un impact sur l'accès au marché des dispositifs médicaux.
Book Synopsis Nouveau règlement européen sur les dispositifs médicaux by : Lorine Foux
Download or read book Nouveau règlement européen sur les dispositifs médicaux written by Lorine Foux and published by . This book was released on 2017 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le nouveau règlement européen a été adopté le 5 avril 2017. Il promet de nombreuses évolutions dans la réglementation en renforçant l'encadrement des dispositifs médicaux (DM) mis sur le marché européen, et notamment le niveau d'exigence en preuves cliniques. La première partie fait l'état des lieux des évolutions qu'apporte le règlement 2017/745 par rapport aux directives 93/42/CEE et 90/385/CEE. La deuxième partie développe les interprétations du texte selon différentes perspectives, celle des fabricants de DM, celle des autorités de santé françaises et celle de consultants spécialisés dans les dispositifs médicaux. Enfin, la dernière partie met en perspective l'impact que pourrait avoir le nouveau règlement sur les industriels, sur l'accès au marché des DM en France et propose des recommandations aux fabricants pour mieux appréhender l'application de ce règlement 2017/745. Ce règlement permettra une harmonisation de l'évaluation des dispositifs, une élévation de la sécurité pour les patients et surtout une valorisation du marquage CE. Il aura des conséquences sur les entreprises de dispositifs médicaux en France en termes organisationnels, temporels et financiers.
Book Synopsis Dispositifs médicaux by : Alice Fouretier
Download or read book Dispositifs médicaux written by Alice Fouretier and published by . This book was released on 2013 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les dispositifs médicaux (DM) sont des produits de santé contribuant à améliorer la qualité et l'efficacité des soins de santé. Le marché européen du DM est actuellement encadré par les directives 90/385/CEE, 93/42/CEE et 2007 /42/CE. Cependant, la règlementation actuelle est devenue inadaptée aux évolutions technologiques. De plus, les affaires sanitaires récentes ont mis en évidence l'existence de défaillances. C'est pourquoi, la Commission européenne a publié une proposition de règlement en septembre 2012. Ce travail a pour objectif d'analyser les dispositions du nouveau règlement au regard de la législation actuelle et d'en évaluer l'impact potentiel pour un promoteur français d'essais cliniques. La proposition de règlement sur les DM définit de nouveau acteurs : les laboratoires de référence, le groupe de coordination des DM et la personne qualifiée du fabricant. Avec un champ d'application étendu, le marquage CE ne sera pas fondamentalement remis en question, mais renforcé, en particulier pour les DM à haut risque. Les DM seront également sujets à une surveillance post-commercialisation accrue via l'élargissement des pouvoirs accordés aux organismes notifiés et l'harmonisation de la matériovigilance en Europe. Afin de renforcer la transparence du secteur, le système d'identifiant unique des dispositifs (UDI) sera mis en place. Code alphanumérique spécifique d'un dispositif, I'UDI permettra d'accéder aux informations relatives aux DM et aux fabricants. Par ailleurs, le développement de la base européenne EUDAMED sera poursuivi avec instauration d'un accès public adapté tout en garantissant la protection des données à caractère personnel et des données commerciales sensibles. Se rapprochant de la législation du médicament, le nouveau règlement permettra ainsi la commercialisation de DM garantissant un niveau élevé de protection de la santé tout en favorisant l'accès à l'innovation. Pour les investigations cliniques, les dispositions du règlement impacteront essentiellement les études conduites au sein de plusieurs Etats membres de l'Union Européenne. En effet, outre une harmonisation des pratiques, ces investigations pourront faire l'objet d'une demande d'autorisation via la mise en place d'un portail électronique d'échange d'information. En parallèle, de nouvelles exigences de vigilance seront définies. Ces dispositions sont toutefois en discordance avec le projet de décret de la loi Jardé. Au lieu de transmettre tous les évènements indésirables graves, seuls les effets graves seront à déclaration obligatoire aux autorités compétentes. Loi Jardé mis à part, le règlement devrait simplifier l'activité des promoteurs, en particulier pour les essais européens. Plusieurs textes législatifs avec impact potentiel sur les promoteurs d'essais cliniques sont en cours d'élaboration en France et en Europe. Les promoteurs se doivent donc de se maintenir informés des évolutions à venir afin d'appliquer le plus rapidement possible les nouvelles exigences
Book Synopsis Handbook of Data Science Approaches for Biomedical Engineering by : Valentina Emilia Balas
Download or read book Handbook of Data Science Approaches for Biomedical Engineering written by Valentina Emilia Balas and published by Academic Press. This book was released on 2019-11-13 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Data Science Approaches for Biomedical Engineering covers the research issues and concepts of biomedical engineering progress and the ways they are aligning with the latest technologies in IoT and big data. In addition, the book includes various real-time/offline medical applications that directly or indirectly rely on medical and information technology. Case studies in the field of medical science, i.e., biomedical engineering, computer science, information security, and interdisciplinary tools, along with modern tools and the technologies used are also included to enhance understanding. Today, the role of Big Data and IoT proves that ninety percent of data currently available has been generated in the last couple of years, with rapid increases happening every day. The reason for this growth is increasing in communication through electronic devices, sensors, web logs, global positioning system (GPS) data, mobile data, IoT, etc. Provides in-depth information about Biomedical Engineering with Big Data and Internet of Things Includes technical approaches for solving real-time healthcare problems and practical solutions through case studies in Big Data and Internet of Things Discusses big data applications for healthcare management, such as predictive analytics and forecasting, big data integration for medical data, algorithms and techniques to speed up the analysis of big medical data, and more
Book Synopsis Spaces and Identities in Border Regions by : Christian Wille
Download or read book Spaces and Identities in Border Regions written by Christian Wille and published by transcript Verlag. This book was released on 2015-11-30 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spatial and identity research operates with differentiations and relations. These are particularly useful heuristic tools when examining border regions where social and geopolitical demarcations diverge. Applying this approach, the authors of this volume investigate spatial and identity constructions in cross-border contexts as they appear in everyday, institutional and media practices. The results are discussed with a keen eye for obliquely aligned spaces and identities and relinked to governmental issues of normalization and subjectivation. The studies base upon empirical surveys conducted in Germany, France, Belgium and Luxembourg.
Download or read book Doing Business 2020 written by World Bank and published by World Bank Publications. This book was released on 2019-11-21 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Seventeen in a series of annual reports comparing business regulation in 190 economies, Doing Business 2020 measures aspects of regulation affecting 10 areas of everyday business activity.
Book Synopsis Expanding the Lexicon by : Sabine Arndt-Lappe
Download or read book Expanding the Lexicon written by Sabine Arndt-Lappe and published by Walter de Gruyter GmbH & Co KG. This book was released on 2018-01-22 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: The creation of new lexical units and patterns has been studied in different research frameworks, focusing on either system-internal or system-external aspects, from which no comprehensive view has emerged. The volume aims to fill this gap by studying dynamic processes in the lexicon – understood in a wide sense as not being necessarily limited to the word level – by bringing together approaches directed to morphological productivity as well as approaches analyzing general types of lexical innovation and the role of discourse-related factors. The papers deal with ongoing changes as well as with historical processes of change in different languages and reflect on patterns and specific subtypes of lexical innovation as well as on their external conditions and the speakers’ motivations for innovating. Moreover, the diffusion and conventionalization of innovations will be addressed. In this way, the volume contributes to understanding the complex interplay of structural, cognitive and functional factors in the lexicon as a highly dynamic domain.
Author :Food and Agriculture Organization of the United Nations Publisher :Food & Agriculture Org. ISBN 13 :9251312362 Total Pages :166 pages Book Rating :4.2/5 (513 download)
Book Synopsis Taking a Multisectoral One Health Approach : A Tripartite Guide to Addressing Zoonotic Diseases in Countries by : Food and Agriculture Organization of the United Nations
Download or read book Taking a Multisectoral One Health Approach : A Tripartite Guide to Addressing Zoonotic Diseases in Countries written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2019-03-11 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2018 FAO-OIE-WHO (Tripartite) zoonoses guide, “Taking A Multisectoral, One Health Approach: A Tripartite Guide to Addressing Zoonotic Diseases in Countries” (2018 TZG) is being jointly developed to provide member countries with practical guidance on OH approaches to build national mechanisms for multisectoral coordination, communication, and collaboration to address zoonotic disease threats at the animal-human-environment interface. The 2018 TZG updates and expands on the guidance in the one previous jointly-developed, zoonoses-specific guidance document: the 2008 Tripartite “Zoonotic Diseases: A Guide to Establishing Collaboration between Animal and Human Health Sectors at the Country Level”, developed in WHO South-East Asia Region and Western Pacific Region. The 2018 TZG supports building by countries of the resilience and capacity to address emerging and endemic zoonotic diseases such as avian influenza, rabies, Ebola, and Rift Valley fever, as well as food-borne diseases and antimicrobial resistance, and to minimize their impacts on health, livelihoods, and economies. It additionally supports country efforts to implement WHO International Health Regulations (2005) and OIE international standards, to address gaps identified through external and internal health system evaluations, and to achieve targets of the Sustainable Development Goals. The 2018 TZG provides relevant country ministries and agencies with lessons learned and good practices identified from country-level experiences in taking OH approaches for preparedness, prevention, detection and response to zoonotic disease threats, and provides guidance on multisectoral communication, coordination, and collaboration. It informs on regional and country-level OH activities and relevant unisectoral and multisectoral tools available for countries to use.
Book Synopsis Street Addressing and the Management of Cities by : Catherine Farvacque-Vitkovi?
Download or read book Street Addressing and the Management of Cities written by Catherine Farvacque-Vitkovi? and published by World Bank Publications. This book was released on 2005 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: There has been a dramatic demographic shift from rural areas to cities in sub-Saharan African countries over the last few decades. This continuing urbanisation trend has created new challenges for local governments in terms of managing urban services, since over half of the city streets in these countries have no names or addresses, and the problem is particularly acute in the poorest neighbourhoods. This publication examines the use of street addressing initiatives to address this problem, giving information on current and future applications, considering examples of use in many African countries, and setting out a methodological guide for implementing such initiatives.
Book Synopsis Science and Empires by : P. Petitjean
Download or read book Science and Empires written by P. Petitjean and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: SCIENCE AND EMPIRES: FROM THE INTERNATIONAL COLLOQUIUM TO THE BOOK Patrick PETITJEAN, Catherine JAMI and Anne Marie MOULIN The International Colloquium "Science and Empires - Historical Studies about Scientific De velopment and European Expansion" is the product of an International Colloquium, "Sciences and Empires - A Comparative History of Scien tific Exchanges: European Expansion and Scientific Development in Asian, African, American and Oceanian Countries". Organized by the REHSEIS group (Research on Epistemology and History of Exact Sciences and Scientific Institutions) of CNRS (National Center for Scientific Research), the colloquium was held from 3 to 6 April 1990 in the UNESCO building in Paris. This colloquium was an idea of Professor Roshdi Rashed who initiated this field of studies in France some years ago, and proposed "Sciences and Empires" as one of the main research programmes for the The project to organize such a colloquium was a bit REHSEIS group. of a gamble. Its subject, reflected in the title "Sciences and Empires", is not a currently-accepted sub-discipline of the history of science; rather, it refers to a set of questions which found autonomy only recently. The terminology was strongly debated by the participants and, as is frequently suggested in this book, awaits fuller clarification.
Author :Frédéric Bourdier Publisher :Centre for East and South-East Asian Studies Lund University ISBN 13 : Total Pages :36 pages Book Rating :4.3/5 (91 download)
Book Synopsis Policies and Politics Underlying the Path for Universal Access to Treatment Against AIDS in Cambodia by : Frédéric Bourdier
Download or read book Policies and Politics Underlying the Path for Universal Access to Treatment Against AIDS in Cambodia written by Frédéric Bourdier and published by Centre for East and South-East Asian Studies Lund University. This book was released on 2006 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Knowing our lands and resources by : Roué, Marie
Download or read book Knowing our lands and resources written by Roué, Marie and published by UNESCO Publishing. This book was released on 2017-04-03 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Labour Rights as Human Rights by : Philip Alston
Download or read book Labour Rights as Human Rights written by Philip Alston and published by Collected Courses of the Acade. This book was released on 2005 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Are efforts to protect workers' rights compatible with the forces of globalization? How can minimum standards designed to protect labour rights be implemented in a world in which national labour law is more and more at the mercy of international forces beyond its control? And does it makeany difference if we see rights such as the right to freedom of association, to non-discrimination in the workplace, to freedom from child labour, and to safe and healthy working conditions in terms of international human rights law? Or are they more appropriately seen as 'principles' to bepromoted as and where appropriate?The contributors to this volume argue that international agreements and institutions are of central importance if labour rights are to be protected in a globalized economy. But the report cards they give to the World Trade Organization, the European Union, NAFTA, and the Free Trade Agreement of theAmericas are generally very critical. While there is a strong rhetorical commitment to labour rights, at least on the part of the US and the EU, the substance of what has been achieved to date is hardly impressive. The role of the International Labour Organization is central and the authorsexplore some of the options that are open to governments, civil society, and the labour movement in the years ahead.
Book Synopsis Hà Nội, a Metropolis in the Making by : Collectif
Download or read book Hà Nội, a Metropolis in the Making written by Collectif and published by IRD Éditions. This book was released on 2018-11-19 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: Built on 'the bend in the Red River', Hà Nội is among Southeast Asia's most ancient capitals. Over the centuries, it took shape in part from a dense substratum of villages. With the economic liberalisation of the 1980s, it encountered several obstacles to its expansion: absence of a real land market, high population densities, the government's food self-suffciency policy that limits expropriations of land and the water management constraints of this very vulnerable delta. Since the beginning of the new millennium, the change in speed brought about by the state and by property developers in the construction and urban planning of the province-capital poses the problem of integration of in situ urbanised villages, the importance of preserving a green belt around Hà Nội and the necessity of protection from flooding. The harmonious fusion of city and countryside, which has always constituted the Red River Delta's defining feature, appears to be in jeopardy. Working from a rich body of maps and field studies, this collective work reveals how this grass-roots urbanisation encounters 'top-down' urbanisation, or metropolisation. By combining a variety of disciplinary approaches on several different scales, through a study of spatial issues and social dynamics, this atlas not only enables the reader to gauge the impact of major projects on the lives of villages integrated into the city's fabric but also to re-establish the peri-urban village stratum as a fully-fledged actor in the diversity of this emerging metropolis.
Book Synopsis The Radiological Accident in Goiânia by : International Atomic Energy Agency
Download or read book The Radiological Accident in Goiânia written by International Atomic Energy Agency and published by . This book was released on 1988 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Government and authorities in Brazil were faced with a tragic accident in Goiânia resulting from the misuse of a strongly radioactive medical teletherapy source not under radiation protection surveillance. The present report is divided into four parts: a chronology of destruction of the source, discovery of the accident and initial response; a description of the human consequences and the dosimetry and treatment of seriously exposed and contaminated persons; an account of the assessment of the environmental contamination and the remedial actions taken; and observations and recommendations. Appendices and annexes give an assessment of the effectiveness of international co-operation in the emergency response, and provide further information on: public communications; radiological survey equipment; guidelines for the discharge of patients; radiological protection; chemical decontamination; and the lessons learned.
Book Synopsis Water & Heritage by : Willem Willems
Download or read book Water & Heritage written by Willem Willems and published by . This book was released on 2017-01-15 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Water is vital for life, and its availability has been a concern for mankind throughout the ages. Its presence has always been ascertained in a variety of ways and the development of human society everywhere is connected with various forms of water management. Man also needed to manage water to find protection from its dangers and the need for that is increasing. In the coming decades, the impact of climate change is expected to intensify floods and droughts, affect groundwater resources, raise sea levels, increase pollution and enhance the frequency and magnitude of disasters. Societies around the world are challenged to adapt to these threats to ensure water security, economic prosperity and environmental and cultural sustainability. This book deals with the heritage of water management and the use that was made of water, as well as the impact of water management on heritage. An example of the former may be an ancient irrigation system in the Filipines or in the Middle East that still functions today, while the latter may reflect the importance of maintaining groundwater levels for the preservation of organic remains on archaeological sites or of wooden piles underneath standing buildings. In either case the papers in this book reflect the dynamic nature of water, and hence the equally dynamic relation between water management and heritage. This publication follows up on a Heritage and Water conference in Amsterdam, the first of its kind. Its main purpose is to credibly present the importance and value of heritage and historical experience for water and sustainable development, and vice versa, present the importance of water management for the protection of heritage. It presents evolving insights and concepts about Water and about Heritage from a variety of disciplines, policy and public perspectives illustrated with cases studies and aims to connect decision makers with experts such as engineers, archaeologists, historians, geographers, ecologist and landscape architects
