L'Autorisation de mise sur le marché globale et son application dans l'Union européenne

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Publisher :
ISBN 13 :
Total Pages : 111 pages
Book Rating : 4.:/5 (836 download)

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Book Synopsis L'Autorisation de mise sur le marché globale et son application dans l'Union européenne by : Élodie Cuzon

Download or read book L'Autorisation de mise sur le marché globale et son application dans l'Union européenne written by Élodie Cuzon and published by . This book was released on 2012 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'Union européenne a notamment pour but d'assurer un niveau élevé de protection de la santé publique dans les différents États membres. Un des moyens d'assurer un accès égalitaire aux médicaments pour les différents peuples est le développement des médicaments génériques. Le médicament générique peut être commercialisé quelques années après l'arrivée sur le marché du médicament de référence et à un prix moindre. Les autorités de santé des états peuvent ainsi faire des économies en frais de santé du fait de son prix et de son remboursement moins élevé. La directive 2004/27/CE permet de cadrer la commercialisation des médicaments génériques en délimitant assez clairement les conditions de protection des données du dossier d'autorisation de mise sur le marché du médicament de référence. Elle introduit aussi la notion d'autorisation de mise sur le marché globale pour un produit. Il s'agit de "regrouper" toutes les autorisations obtenues pour ce médicament, que cela concerne les différents dosages, formes pharmaceutiques, indications, etc. dans le but que ce médicament ne puisse bénéficier que d'une période unique de protection des données courant à partir de l'obtention de la première autorisation de mise sur le marché. Cette durée unique permet une commercialisation des génériques de ce médicament plus rapide que celle permise par les réglementations précédentes. La notion d'autorisation de mise sur le marché globale a été transposée en France et dans les pays européens. Les laboratoires de médicaments de référence mettent en place des stratégies pour contourner cette réglementation qui favorise l'accession des médicaments génériques au marché, notamment en se tournant vers la protection de la propriété intellectuelle.

Developpement et enregistrement d'un nouveau médicament aux Etats-Unis

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Publisher :
ISBN 13 :
Total Pages : 166 pages
Book Rating : 4.:/5 (491 download)

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Book Synopsis Developpement et enregistrement d'un nouveau médicament aux Etats-Unis by : Véronique Langlet

Download or read book Developpement et enregistrement d'un nouveau médicament aux Etats-Unis written by Véronique Langlet and published by . This book was released on 2004 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le développement d'un médicament aux Etats-Unis implique une étroite collaboration entre le laboratoire pharmaceutique et la Food and Drug Administration (FDA), agence chargée de la sécurité sanitaire et alimentaire délivrant les autorisations de mise sur le marché des médicaments sur le territoire américain. Les deux étapesz primordiales du développement d'un médicament sont la soumission auprès de la FDA de dossiers de demande d'autorisation pour : d'une part, conduire des études cliniques : il s'agit de l'Investigational New Drung (IND) ; d'autre part, obtenir l'autorisation de mise sur le marché : il s'agit de du New Drug Application (NDA). Chacun de ces dossiers, soumis à des moments différents au cours du développement, rassemble toutes les informations connues sur la qualité, la sécurité et l'efficacité du médicament. Dans une première partie sont exposées toutes les étapes qu'un laboratoire doit franchir pour développer une nouvelle entité chimique aux Etats-Unis. La deuxième partie décrit en détail l'IND et le NDA, notamment leur contenu et leur évaluation par le Center for Drug, Evaluation and Researche (CDER), bureau d'évaluation des médicaments autres que biologiques au sein de la FDA.

Doing Business 2020

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Publisher : World Bank Publications
ISBN 13 : 1464814414
Total Pages : 241 pages
Book Rating : 4.4/5 (648 download)

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Book Synopsis Doing Business 2020 by : World Bank

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.

World Abortion Policies

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Publisher : Economic & Social Affairs
ISBN 13 : 9789211515015
Total Pages : 0 pages
Book Rating : 4.5/5 (15 download)

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Book Synopsis World Abortion Policies by :

Download or read book World Abortion Policies written by and published by Economic & Social Affairs. This book was released on 2013-06-26 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Global Burden of Disease and Risk Factors

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Publisher : World Bank Publications
ISBN 13 : 0821362631
Total Pages : 511 pages
Book Rating : 4.8/5 (213 download)

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Book Synopsis Global Burden of Disease and Risk Factors by : Alan D. Lopez

Download or read book Global Burden of Disease and Risk Factors written by Alan D. Lopez and published by World Bank Publications. This book was released on 2006-04-02 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.

Contemporary Criminological Issues

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Publisher : University of Ottawa Press
ISBN 13 : 0776628720
Total Pages : 396 pages
Book Rating : 4.7/5 (766 download)

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Book Synopsis Contemporary Criminological Issues by : Carolyn Côté-Lussier

Download or read book Contemporary Criminological Issues written by Carolyn Côté-Lussier and published by University of Ottawa Press. This book was released on 2020-05-05 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contemporary Criminological Issues tackles some of today’s most pressing social issues, from the criminalization of Indigenous peoples to interpersonal violence, border control, and armed conflicts. This book advances cutting-edge theories and methods, with the aim of moving beyond the scholarship that reproduces insecurity and exclusion. The breadth of approaches encompasses much of the current critical criminological scholarship, serving as a counterpoint to the growth of managerial and administrative criminologies and the rise of explicitly exclusionary and punitive state policies and practices with respect to ‘crime’ and ‘security.’ This edited collection featuring two books, one in English and one in French, includes important contributions to knowledge and public policy by eminent experts and emerging scholars. This book is published in English.

A Frequency Dictionary of French

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Publisher : Routledge
ISBN 13 : 1135973504
Total Pages : 974 pages
Book Rating : 4.1/5 (359 download)

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Book Synopsis A Frequency Dictionary of French by : Deryle Lonsdale

Download or read book A Frequency Dictionary of French written by Deryle Lonsdale and published by Routledge. This book was released on 2009-03-25 with total page 974 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Frequency Dictionary of French is an invaluable tool for all learners of French, providing a list of the 5000 most frequently used words in the language. Based on a 23-million-word corpus of French which includes written and spoken material both from France and overseas, this dictionary provides the user with detailed information for each of the 5000 entries, including English equivalents, a sample sentence, its English translation, usage statistics, and an indication of register variation. Users can access the top 5000 words either through the main frequency listing or through an alphabetical index. Throughout the frequency listing there are thematically-organized lists of the top words from a variety of key topics such as sports, weather, clothing, and family terms. An engaging and highly useful resource, the Frequency Dictionary of French will enable students of all levels to get the most out of their study of French vocabulary. Former CD content is now available to access at www.routledge.com/9780415775311 as support material. Designed for use by corpus and computational linguists it provides the full text in a format that researchers can process and turn into suitable lists for their own research work. Deryle Lonsdale is Associate Professor in the Linguistics and English Language Department at Brigham Young University (Provo, Utah). Yvon Le Bras is Associate Professor of French and Department Chair of the French and Italian Department at Brigham Young University (Provo, Utah).

Frontline and Factory

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Publisher : Springer Science & Business Media
ISBN 13 : 1402054904
Total Pages : 292 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Frontline and Factory by : Roy MacLeod

Download or read book Frontline and Factory written by Roy MacLeod and published by Springer Science & Business Media. This book was released on 2007-05-06 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents a first considered attempt to study the factors that conditioned industrial chemistry for war in 1914-18. Taking a comparative perspective, it reflects on the experience of France, Germany, Austria, Russia, Britain, Italy and Russia, and points to significant similarities and differences. It looks at changing patterns in the organisation of industry, and at the emerging symbiosis between science, industry and the military.

Comprehensive Cervical Cancer Control

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Publisher : World Health Organization
ISBN 13 : 9241547006
Total Pages : 284 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Comprehensive Cervical Cancer Control by : World Health Organization

Download or read book Comprehensive Cervical Cancer Control written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most women who die from cervical cancer, particularly in developing countries, are in the prime of their life. They may be raising children, caring for their family, and contributing to the social and economic life of their town or village. Their death is both a personal tragedy, and a sad and unnecessary loss to their family and their community. Unnecessary, because there is compelling evidence, as this Guide makes clear, that cervical cancer is one of the most preventable and treatable forms of cancer, as long as it is detected early and managed effectively. Unfortunately, the majority of women in developing countries still do not have access to cervical cancer prevention programmes. The consequence is that, often, cervical cancer is not detected until it is too late to be cured. An urgent effort is required if this situation is to be corrected. This Guide is intended to help those responsible for providing services aimed at reducing the burden posed by cervical cancer for women, communities and health systems. It focuses on the knowledge and skills needed by health care providers, at different levels of care.

Computers and Games for Mental Health and Well-Being

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Publisher : Frontiers Media SA
ISBN 13 : 2889454967
Total Pages : 311 pages
Book Rating : 4.8/5 (894 download)

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Book Synopsis Computers and Games for Mental Health and Well-Being by : Yasser Khazaal

Download or read book Computers and Games for Mental Health and Well-Being written by Yasser Khazaal and published by Frontiers Media SA. This book was released on 2018-07-12 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent years have seen important developments in the computer and game industry, including the emergence of the concept of serious games. It is hypothesized that tools such as games, virtual reality, or applications for smartphones may foster learning, enhance motivation, promote behavioral change, support psychotherapy, favor empowerment, and improve some cognitive functions. Computers and games may create supports for training or help people with cognitive, emotional, or behavioral change. Games take various formats, from board games to informatics to games with interactive rules of play. Similarly, computer tools may vary widely in format, from self-help or assisted computerized training to virtual reality or applications for smartphones. Some tools that may be helpful for mental health were specifically designed for that goal, whereas others were not. Gamification of computer-related products and games with a numeric format tend to reduce the gap between games and computers tools and increase the conceptual synergy in such fields. Games and computer design share an opportunity for creativity and innovation to help create, specifically design, and assess preventive or therapeutic tools. Computers and games share a design conception that allows innovative approaches to overcome barriers of the real world by creating their own rules. Yet, despite the potential interest in such tools to improve treatment of mental disorders and to help prevent them, the field remains understudied and information is under-disseminated in clinical practice. Some studies have shown, however, that there is potential interest and acceptability of tools that support various vehicles, rationales, objectives, and formats. These tools include traditional games (e.g., chess games), popular electronic games, board games, computer-based interventions specifically designed for psychotherapy or cognitive training, virtual reality, apps for smartphones, and so forth. Computers and games may offer a true opportunity to develop, assess, and disseminate new prevention and treatment tools for mental health and well-being. Currently, there is a strong need for state-of-the-art information to answer questions such as the following: Why develop such tools for mental health and well-being? What are the potential additions to traditional treatments? What are the best strategies or formats to improve the possible impact of these tools? Are such tools useful as a first treatment step? What is the potential of a hybrid model of care that combines traditional approaches with games and/or computers as tools? What games and applications have already been designed and studied? What is the evidence from previous studies? How can such tools be successfully designed for mental health and well-being? What is rewarding or attractive for patients in using such treatments? What are the worldwide developments in the field? Are some protocols under development? What are the barriers and challenges related to such developments? How can these tools be assessed, and how can the way that they work, and for whom, be measured? Are the potential benefits of such products specific, or can these additions be attributed to nonspecific factors? What are the users’ views on such tools? What are the possible links between such tools and social networks? Is there a gap between evidence-based results and market development? Are there any quality challenges? What future developments and studies are needed in the field?

Managing Epidemics

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Publisher :
ISBN 13 : 9789240698345
Total Pages : pages
Book Rating : 4.6/5 (983 download)

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Book Synopsis Managing Epidemics by :

Download or read book Managing Epidemics written by and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Health System Performance Comparison: an Agenda for Policy, Information and Research

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Publisher : McGraw-Hill Education (UK)
ISBN 13 : 033524727X
Total Pages : 418 pages
Book Rating : 4.3/5 (352 download)

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Book Synopsis Health System Performance Comparison: an Agenda for Policy, Information and Research by : Irene Papanicolas

Download or read book Health System Performance Comparison: an Agenda for Policy, Information and Research written by Irene Papanicolas and published by McGraw-Hill Education (UK). This book was released on 2013-06-16 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: International comparison of health system performance has become increasingly popular, made possible by the rapidly expanding availability of health data. It has become one of the most important levers for prompting health system reform. Yet, as the demand for transparency and accountability in healthcare increases, so too does the need to compare data from different health systems both accurately and meaningfully. This timely and authoritative book offers an important summary of the current developments in health system performance comparison. It summarises the current state of efforts to compare systems, and identifies and explores the practical and conceptual challenges that occur. It discusses data and methodological challenges, as well as broader issues such as the interface between evidence and practice. The book draws out the priorities for future work on performance comparison, in the development of data sources and measurement instruments, analytic methodology, and assessment of evidence on performance. It concludes by presenting the key lessons and future priorities, and in doing so offers a rich source of material for policy-makers, their analytic advisors, international agencies, academics and students of health systems.

Health Workforce Policies in OECD Countries

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Publisher : Org. for Economic Cooperation & Development
ISBN 13 : 9789264239500
Total Pages : 0 pages
Book Rating : 4.2/5 (395 download)

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Book Synopsis Health Workforce Policies in OECD Countries by : OECD

Download or read book Health Workforce Policies in OECD Countries written by OECD and published by Org. for Economic Cooperation & Development. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Foreword and Acknowledgments -- Executive summary -- Key findings -- Analytical framework of health labour markets -- Trends in health labour markets and policy priorities to address workforce issues -- Education and training for doctors and nurses: What's happening with numerus clausus policies? -- Trends and policies affecting the international migration of doctors and nurses to OECD countries -- Geographic imbalances in the distribution of doctors and health care services in OECD countries -- Skills use and skills mismatch in the health sector: What do we know and what can be done

Biowarfare in America

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Publisher : Illuminet Press
ISBN 13 : 9781881532217
Total Pages : 128 pages
Book Rating : 4.5/5 (322 download)

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Book Synopsis Biowarfare in America by : Jim Keith

Download or read book Biowarfare in America written by Jim Keith and published by Illuminet Press. This book was released on 1999 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: The era of chemical and biological megadeath is upon us, and the potential of deadly biowarfare attacks from governments, militant independent groups, and even individuals is far greater than it has been at any time in the past. At this time, more than twenty-five countries are developing, or have stockpiles of chemical and biological weapons, in many cases in sufficient quantities to wipe out the entire population of the world. So far the danger of chemical and biological aggression has been little acknowledged, and, at least in America, little prepared for by federal and local government. Most terrorist threats and attacks are not widely reported in the mainstream media. Although information about the proliferation of man-made diseases is carefully suppressed by governments and the media they will be covered in the pages of this book. Not only is America unprepared and ignorant of what is happening, but the people in government and scientific professions who do know, who should be warning the American public about the dangers of chemical and biological terrorism, are instead doing their utmost to hide this information from us; information that is vital for our survival.The information that is contained in the pages of this book will not be measured or calculated to reassure people that everything is fine, when reassurance is the exact opposite of what is needed at this time. It may even give you nightmares when you realise the real circumstance that we are in. The information in the pages that follow will be the truth about the biowarfare threat to America.

Hollywood, the Pentagon and Washington

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Publisher : Anthem Press
ISBN 13 : 1843311704
Total Pages : 174 pages
Book Rating : 4.8/5 (433 download)

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Book Synopsis Hollywood, the Pentagon and Washington by : Jean-Michel Valantin

Download or read book Hollywood, the Pentagon and Washington written by Jean-Michel Valantin and published by Anthem Press. This book was released on 2005 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concerned investigation of the curious relationship between Hollywood and the US Department of Defense that exposes some distressing collaborations.

Molecular Mechanisms of Hormone Action

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Publisher :
ISBN 13 :
Total Pages : 224 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Molecular Mechanisms of Hormone Action by : Gesellschaft für Biologische Chemie. Colloquium

Download or read book Molecular Mechanisms of Hormone Action written by Gesellschaft für Biologische Chemie. Colloquium and published by . This book was released on 1989 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Historical Dictionary of Iran

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Publisher : Historical Dictionaries of Asia, Oceania, and the Middle East
ISBN 13 :
Total Pages : 570 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Historical Dictionary of Iran by : John Henry Lorentz

Download or read book Historical Dictionary of Iran written by John Henry Lorentz and published by Historical Dictionaries of Asia, Oceania, and the Middle East. This book was released on 2007 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides an overview of specific events, movements, people, political and social groups, places, trends, and chronology. Allows for considerable exploration of a number of historical and contemporary topics and issues. The modern period, defined as 1800-present, is covered extensively.