Limportance Des Donnees De Securite Post Commercialisation Des Medicaments Orphelins

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L’importance des données de sécurité post-commercialisation des médicaments orphelins

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Author : Gabrielle Fourcade
Publisher :
ISBN 13 :
Total Pages : 186 pages
Book Rating : 4.:/5 (131 download)

Book Synopsis L’importance des données de sécurité post-commercialisation des médicaments orphelins by : Gabrielle Fourcade

Download or read book L’importance des données de sécurité post-commercialisation des médicaments orphelins written by Gabrielle Fourcade and published by . This book was released on 2022 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: La pandémie de la COVID-19 et l'autorisation de mise sur le marché des vaccins ont mis en lumière une problématique bien connue : comment les autorités peuvent-elles assurer la sécurité des médicaments tout en permettant un accès rapide au marché pour des produits innovants et nécessaires à leur population ? Comment évaluer la balance bénéfices-risques lorsque les données manquent par manque de temps ou de patients ? Toutes ces questions ont conduit l'Union européenne et sa Commission à mettre en place des réglementations spécifiques qui visent à donner un accès rapide et sûr à des produits de santé répondant à des critères précis. Pour répondre à des attentes légitimes de la part des patients et des populations tout en augmentant la réactivité des industries de santé face à une évolution rapide des connaissances scientifiques, il a paru important de mettre en place des procédures d'évaluations plus rapides réservées aux médicaments ayant un intérêt thérapeutique majeur. La mise en place d'une réglementation spécifique aux médicaments orphelins accompagné d'une exclusivité de marché, a grandement stimulé la recherche et le développement dans ce secteur. En permettant la collecte de données de sécurité après l'autorisation de mise sur le marché, la rareté d'une condition est une barrière de la recherche clinique qu'il est aujourd'hui possible de surmonter. Les patients atteints de maladies rares ont le droit à la même sécurité, efficacité et qualité que les autres patients. Grâce aux bons outils réglementaires, il est possible de surveiller de manière rapprochée la sécurité d'un médicament après l'autorisation d'un produit au niveau européen ainsi que d'en minimiser les risques.

Preventing Regulatory Capture

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Author : Daniel Carpenter
Publisher : Cambridge University Press
ISBN 13 : 1107036089
Total Pages : 531 pages
Book Rating : 4.1/5 (7 download)

Book Synopsis Preventing Regulatory Capture by : Daniel Carpenter

Download or read book Preventing Regulatory Capture written by Daniel Carpenter and published by Cambridge University Press. This book was released on 2014 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.

How to Hold a Crocodile

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Author : Diagram Group
Publisher : Firefly Books
ISBN 13 : 9781552978054
Total Pages : 200 pages
Book Rating : 4.9/5 (78 download)

Book Synopsis How to Hold a Crocodile by : Diagram Group

Download or read book How to Hold a Crocodile written by Diagram Group and published by Firefly Books. This book was released on 2003 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains how to do practical and improbable things, such as how to roast an ox, handle a hamster, photography a fish, play the bagpipes, and vanquish a vampire.].

The Politics of Global Regulation

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Author : Walter Mattli
Publisher : Princeton University Press
ISBN 13 : 9780691139616
Total Pages : 316 pages
Book Rating : 4.1/5 (396 download)

Book Synopsis The Politics of Global Regulation by : Walter Mattli

Download or read book The Politics of Global Regulation written by Walter Mattli and published by Princeton University Press. This book was released on 2009-05-17 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Regulation by public and private organizations can be hijacked by special interests or small groups of powerful firms, and nowhere is this easier than at the global level ... This is the first book to examine systematically how and why such hijacking or 'regulatory capture' happens, and how it can be averted."--P. [iv] of cover.

The Political Economy of Regulation

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Author : Barry M. Mitnick
Publisher : New York : Columbia University Press
ISBN 13 :
Total Pages : 544 pages
Book Rating : 4.:/5 (43 download)

Book Synopsis The Political Economy of Regulation by : Barry M. Mitnick

Download or read book The Political Economy of Regulation written by Barry M. Mitnick and published by New York : Columbia University Press. This book was released on 1980 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Regulatory Theory

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Author : Peter Drahos
Publisher : ANU Press
ISBN 13 : 1760461024
Total Pages : 820 pages
Book Rating : 4.7/5 (64 download)

Book Synopsis Regulatory Theory by : Peter Drahos

Download or read book Regulatory Theory written by Peter Drahos and published by ANU Press. This book was released on 2017-02-23 with total page 820 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.

Topics in Romance Syntax

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Author : Osvaldo Jaeggli
Publisher : ISSN
ISBN 13 : 9783112420218
Total Pages : 0 pages
Book Rating : 4.4/5 (22 download)

Book Synopsis Topics in Romance Syntax by : Osvaldo Jaeggli

Download or read book Topics in Romance Syntax written by Osvaldo Jaeggli and published by ISSN. This book was released on 1981 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The architecture of the human language faculty has been one of the main foci of the linguistic research of the last half century. This branch of linguistics, broadly known as Generative Grammar, is concerned with the formulation of explanatory formal accounts of linguistic phenomena with the ulterior goal of gaining insight into the properties of the 'language organ'. The series comprises high quality monographs and collected volumes that address such issues. The topics in this series range from phonology to semantics, from syntax to information structure, from mathematical linguistics to studies of the lexicon. To discuss your book idea or submit a proposal, please contact Birgit Sievert

Global Business Regulation

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Author : John Braithwaite
Publisher : Cambridge University Press
ISBN 13 : 9780521780339
Total Pages : 194 pages
Book Rating : 4.7/5 (83 download)

Book Synopsis Global Business Regulation by : John Braithwaite

Download or read book Global Business Regulation written by John Braithwaite and published by Cambridge University Press. This book was released on 2000-02-13 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: How has the regulation of business shifted from national to global institutions? What are the mechanisms of globalization? Who are the key actors? What of democratic sovereignty? In which cases has globalization been successfully resisted? These questions are confronted across an amazing sweep of the critical areas of business regulation--from contract, intellectual property and corporations law, to trade, telecommunications, labor standards, drugs, food, transport and environment. This book examines the role played by global institutions such as the World Trade Organization, World Health Organization, the OECD, IMF, Moodys and the World Bank, as well as various NGOs and significant individuals. Incorporating both history and analysis, Global Business Regulation will become the standard reference for readers in business, law, politics, and international relations.

Government and Markets

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Author : Edward J. Balleisen
Publisher : Cambridge University Press
ISBN 13 : 0521118484
Total Pages : 579 pages
Book Rating : 4.5/5 (211 download)

Book Synopsis Government and Markets by : Edward J. Balleisen

Download or read book Government and Markets written by Edward J. Balleisen and published by Cambridge University Press. This book was released on 2010 with total page 579 pages. Available in PDF, EPUB and Kindle. Book excerpt: After two generations of emphasis on governmental inefficiency and the need for deregulation, we now see growing interest in the possibility of constructive governance, alongside public calls for new, smarter regulation. Yet there is a real danger that regulatory reforms will be rooted in outdated ideas. As the financial crisis has shown, neither traditional market failure models nor public choice theory, by themselves, sufficiently inform or explain our current regulatory challenges. Regulatory studies, long neglected in an atmosphere focused on deregulatory work, is in critical need of new models and theories that can guide effective policy-making. This interdisciplinary volume points the way toward the modernization of regulatory theory. Its essays by leading scholars move past predominant approaches, integrating the latest research about the interplay between human behavior, societal needs, and regulatory institutions. The book concludes by setting out a potential research agenda for the social sciences.

Apoptosis and Inflammation

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Author : James Winkler
Publisher : Birkhäuser
ISBN 13 : 3034887418
Total Pages : 268 pages
Book Rating : 4.0/5 (348 download)

Book Synopsis Apoptosis and Inflammation by : James Winkler

Download or read book Apoptosis and Inflammation written by James Winkler and published by Birkhäuser. This book was released on 2012-12-06 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Apoptosis is a form of cell death that occurs in a controlled manner and is generally noninflammatory in nature. Apoptosis, or programmed cell death, implies a cell death that is part of a normal physiological process of pruning of unneeded cells. However, many disease conditions utilize apoptosis for pathological ends, resulting in inappropriate cell death and tissue destruction. This book starts with an introduction that reviews the general characteristics of apoptosis, its regulation and its role in physiology and disease. Next, the book focuses on three areas as they relate to inflammatory cells and diseases. The first area consists of chapters on signals for apoptosis important to inflammatory cells, namely growth factors and arachidonic acid metabolism. The next area that the book focuses on are effects at the cellular level, on cell survival versus cell death and signals critical for cell function in both normal and disease states. These topics are covered in chapters on lymphocytes, granulocytes, chondrocytes and keratinocytes. The last area that the book focuses on are events at the level of tissue and disease, looking at the evidence for altered apoptosis and/or apoptotic processes in immune and inflammatory diseases. These topics are covered in chapters on rheumatoid arthritis, osteoarthritis, lupus, psoriasis and renal disease. Together, these chapters will provide the reader with the latest insight in the role of apoptosis in inflammatory cells and diseases. This book starts with an introduction that reviews the general characteristics of apoptosis, its regulation and its role in physiology and disease. Next, the book focuses on three areas as they relate to inflammatory cells and diseases. The first area consists of chapters on signals for apoptosis important to inflammatory cells, namely growth factors and arachidonic acid metabolism. The next area that the book focuses on are effects at the cellular level, on cell survival versus cell death and signals critical for cell function in both normal and disease states. These topics are covered in chapters on lymphocytes, granulocytes, chondrocytes and keratinocytes. The last area that the book focuses on are events at the level of tissue and disease, looking at the evidence for altered apoptosis and/or apoptotic processes in immune and inflammatory diseases. These topics are covered in chapters on rheumatoid arthritis, osteoarthritis, lupus, psoriasis and renal disease. Together, these chapters will provide the reader with the latest insight in the role of apoptosis in inflammatory cells and diseases.

The Oxford Handbook of Classics in Public Policy and Administration

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Author : Steven J. Balla
Publisher : Oxford Handbooks
ISBN 13 : 0199646139
Total Pages : 673 pages
Book Rating : 4.1/5 (996 download)

Book Synopsis The Oxford Handbook of Classics in Public Policy and Administration by : Steven J. Balla

Download or read book The Oxford Handbook of Classics in Public Policy and Administration written by Steven J. Balla and published by Oxford Handbooks. This book was released on 2015 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Handbook brings together a collection of leading international authors to reflect on the influence of central contributions, or classics, that have shaped the development of the field of public policy and administration. The Handbook reflects on a wide range of key contributions to the field, selected on the basis of their international and wider disciplinary impact. Focusing on classics that contributed significantly to the field over the second half of the 20th century, it offers insights into works that have explored aspects of the policy process, of particular features of bureaucracy, and of administrative and policy reforms. Each classic is discussed by a leading international scholars. They offer unique insights into the ways in which individual classics have been received in scholarly debates and disciplines, how classics have shaped evolving research agendas, and how the individual classics continue to shape contemporary scholarly debates. In doing so, this volume offers a novel approach towards considering the various central contributions to the field. The Handbook offers students of public policy and administration state-of-the-art insights into the enduring impact of key contributions to the field.

Protected Area Management

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Author : Barbara Sladonja
Publisher : BoD – Books on Demand
ISBN 13 : 953510697X
Total Pages : 242 pages
Book Rating : 4.5/5 (351 download)

Book Synopsis Protected Area Management by : Barbara Sladonja

Download or read book Protected Area Management written by Barbara Sladonja and published by BoD – Books on Demand. This book was released on 2012-08-08 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protected areas are at the base of the most national and international conservation strategies. Due to the many unpredictable elements in ecology matters, each protected area requires a case-specific set of guidelines but a common issue is how to cope with human interaction. The management of protected areas is replete with challenges and the only way to gain understanding and achieve greater management possibilities is to exchange experiences and knowledge. Environmental managers are aware of that and together with scientists are looking for more modern and better solutions, both with respect to natural resources and human interactions in many issues regarding nature protection. This publication presents reviews and research results on protected areas management, as well as 12 case studies derived from around the world with the aim of improving management effectiveness of the protected areas.

Dying for Growth

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Author : Jim Yong Kim
Publisher :
ISBN 13 :
Total Pages : 736 pages
Book Rating : 4.4/5 (91 download)

Book Synopsis Dying for Growth by : Jim Yong Kim

Download or read book Dying for Growth written by Jim Yong Kim and published by . This book was released on 2000 with total page 736 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is economic growth killing the poor? The Institute for Health and Social Justice brings us the answers in Dying for Growth. An extraordinary collection of fourteen hard-hitting case studies from Haiti to the US, Dying for Growth exposes the interests behind a system that consigns a fifth of the world's population to live (and die) on less than a dollar a day. Rooted in the lives of people waging heart-wrenching struggles against a new, systemic form of poverty, these studies don't just document inequality -- they pinpoint its underlying causes.Looking at the effects of international restructuring strategies on the poor, the increasing control trans-national corporations exert over world health, and the impact of U.S. drug policy on global inequality, Dying for Growth debunks the myths of global capitalism, including: Myth: Throwing loans at developing nations will cure poverty.Fact: As shown in Sickness Amidst Recovery: Public Debt and Private Suffering in a Peruvian Shanty Town, loans can make things worse.Myth: Getting rid of big government automatically improves the standard of living.Fact: Cutting services can lead to calamity, as detailed in Neoliberal Economic Policy, State Desertion and the Russian Health Crisis. Myth: The free market is a panacea.Fact: There's nothing liberating about modern capitalism, as demonstrated in 'Todo Bajo Control': The Costs of 'Free' Trade to Mexican Maquiladora Workers.Dying for Growth concludes with an extensive section on alternatives to standard models. Included is a chapter on health and revolution in Cuba, The Threat of a Good Example, and a plan for action, Pragmatic Solidarity: What You Can Do.With passionrarely found in works of comparable analytic rigor, Dying for Growth tells the stories of people trapped in the machine of growth, and compels readers to recognize that the problem of inequality is not one of insufficient resources, nor even of inefficiency -- the problem is power.

Reputation and Power

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Author : Daniel Carpenter
Publisher : Princeton University Press
ISBN 13 : 1400835119
Total Pages : 825 pages
Book Rating : 4.4/5 (8 download)

Book Synopsis Reputation and Power by : Daniel Carpenter

Download or read book Reputation and Power written by Daniel Carpenter and published by Princeton University Press. This book was released on 2014-04-24 with total page 825 pages. Available in PDF, EPUB and Kindle. Book excerpt: How the FDA became the world's most powerful regulatory agency The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested. Some images inside the book are unavailable due to digital copyright restrictions.

Nature and Culture in the Democratic Republic of Congo

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Author :
Publisher :
ISBN 13 :
Total Pages : 172 pages
Book Rating : 4.F/5 ( download)

Book Synopsis Nature and Culture in the Democratic Republic of Congo by :

Download or read book Nature and Culture in the Democratic Republic of Congo written by and published by . This book was released on 2004 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:

African Cinema

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Author : Manthia Diawara
Publisher : Indiana University Press
ISBN 13 : 9780253207074
Total Pages : 212 pages
Book Rating : 4.2/5 (7 download)

Book Synopsis African Cinema by : Manthia Diawara

Download or read book African Cinema written by Manthia Diawara and published by Indiana University Press. This book was released on 1992-04-22 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manthia Diawara provides an insider's account of the history and current status of African cinema. African Cinema: Politics and Culture is the first extended study in English of Sub-Saharan cinema. Employing an interdisciplinary approach which draws on history, political science, economics, and cultural studies, Diawara discusses such issues as film production and distribution, and film aesthetics from the colonial period to the present. The book traces the growth of African cinema through the efforts of pioneer filmmakers such as Paulin Soumanou Vieyra, Oumarou Ganda, Jean-René Débrix, Jean Rouch, and Ousmane Sembène, the Pan-African Filmmakers' Organization (FEPACI), and the Ougadougou Pan-African Film Festival (FESPACO). Diwara focuses on the production and distribution histories of key films such as Ousmane Sembène's Black Girl and Mandabi (1968) and Souleymane Cissé's Fine (1982). He also examines the role of missionary films in Africa, Débrix's ideas concerning 'magic, ' the links between Yoruba theater and Nigerian cinema, and the parallels between Hindu mythologicals in India and the Yoruba-theater - inflected films in Nigeria. Diawara also looks at film and nationalism, film and popular culture, and the importance of FESPACO. African Cinema: Politics and Culture makes a major contribution to the expanding discussion of Eurocentrism, the canon, and multi-culturalism.

Molecular Mechanisms of Hormone Action

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Author : Gesellschaft für Biologische Chemie. Colloquium
Publisher :
ISBN 13 :
Total Pages : 224 pages
Book Rating : 4.3/5 (91 download)

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: