Autorisation de mise sur le marché des médicaments issus de la biotechnologie : la procedure centralisée PDF Download
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Author: Caroline Bosc
Publisher:
ISBN:
Category :
Languages : fr
Pages : 218
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Book Description
Author: Caroline Bosc
Publisher:
ISBN:
Category :
Languages : fr
Pages : 218
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Book Description
Author: Thomas Devred
Publisher: Wolters Kluwer France
ISBN: 9782721214614
Category : Drug approval
Languages : fr
Pages : 308
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Book Description
Le médicament n'est pas un produit anodin. Il est destiné à prévenir ou à traiter les maladies. En cela, il s'inscrit dans la politique de protection de la santé publique conduite en France et en Europe. Issu, dans la grande majorité des cas, des investissements privés de l'industrie pharmaceutique en recherche et développement, le médicament est également l'objet des politiques adoptées pour encourager l'innovation. Il n'en demeure pas moins une " marchandise " qui, dans l'enceinte du marché communautaire, doit pouvoir circuler librement d'un Etat membre de l'Union européenne à l'autre. Ces trois considérations, protection de la santé publique, encouragement de l'innovation et libre circulation au sein du marché européen, président le principe de l'obligation d'autorisation de mise sur le marché (AMM). Aucun médicament ne peut être commercialisé sans qu'une AMM n'ait été préalablement délivrée par une autorité compétente. C'est précisément cette procédure de mise sur le marché que le présent ouvrage s'emploie à décrypter via une approche des plus pragmatiques et proposer ainsi un outil de " compliance " facile d'accès.
Author: Caroline Roudet
Publisher:
ISBN:
Category :
Languages : fr
Pages : 0
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Book Description
Dans l'intérêt de la Santé Publique, la Communauté Européenne, créée par le Traité de Rome en 1957, a progressivement établi les critères scientifiques communs d'évaluation des médicaments, et harmonisé leurs procédures nationales d'autorisation. Les firmes pharmaceutiques bénéficient désormais de deux types de procédures destinées à faciliter l'enregistrement de leurs médicaments dans les Etats membres. L'une, réservée aux médicaments de haute biotechnologie entraine, d'une part une concertation préalable à toute décision nationale et, d'autre part une protection spéciale de 10 ans contre toute copie. L'autre permet aux firmes ayant déjà obtenu une autorisation dans un Etat membre d'en demander la reconnaissance dans au moins deux autres Etats membres. L'expérience tirée de ces 2 procédures devrait conduire fin 1989 au choix du système européen d'enregistrement le plus approprié pour 1992.
Author:
Publisher:
ISBN:
Category : European Economic Community countries
Languages : en
Pages : 302
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Book Description
Author: Food and Agriculture Organization of the United Nations
Publisher: Food & Agriculture Org.
ISBN: 9789251045411
Category : Business & Economics
Languages : en
Pages : 20
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Book Description
The actual Code of conduct is also available (1996) (ISBN 9251038341).
Author: Food and Agriculture Organization of the United Nations
Publisher: Food & Agriculture Org.
ISBN: 9789251039717
Category : Business & Economics
Languages : en
Pages : 52
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Book Description
Provides annotations to the Principles of Article 9 of the Code of Conduct for Responsible Fisheries. These annotations are meant to serve as general guidance, and should be taken as suggestions or observations intended to assist those interested in identifying their own criteria and options for actions, as well as partners for collaboration, in support of sustainable aquaculture development.
Author: American Society of Health System Pharmacists
Publisher:
ISBN: 9781585286119
Category :
Languages : en
Pages : 840
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Book Description
Author: Abd Samad Moussaoui
Publisher: Seven Stories Press
ISBN: 1609803310
Category : Biography & Autobiography
Languages : en
Pages : 148
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Book Description
Zacarias Moussaoui was arrested in the United States in August 2001. He is currently in a federal prison in Virginia, charged with "conspiring with Osama bin Laden and Al-Qaeda to murder thousands of innocent people in New York, Virginia, and Pennsylvania." Moussaoui , who trained to be a pilot in Oklahoma, admits to being a member of Al-Qaeda but denies involvement in the events of September 11. He has opted to defend himself. Written by his brother, Zacarias, My Brother tells the story of Zac’s life from birth to the time in 1996 when he broke contact with his family and became deeply involved with Muslim fundamentalists in London. It is a unique document about what it is to grow up a Muslim in Western Europe today and how an extremist is made. In Zacarias, My Brother, author Abd Samad Moussaoui describes the struggle that young Arab men and their families endure in Europe, seeking an education and equal opportunity, only to find most avenues of assimilation effectively barred to people of color. At the same time, he authoritatively details the techniques of the extremist sects that recruit potential terrorist cadres. Members of the Wahhabi sect have perfected a rhetoric that appeals to the wounded pride of these young Arab men, Moussaoui writes—for example, offering funds to help them complete their education. Moussaoui deplores the route taken by his brother. He is not in any way an apologist for terrorism. Even so, he shows convincingly that normal young men can end up terrorists, and suggests how and why this happens. Moussaoui shows with gripping clarity how Wahhabism distorts true Islamic faith and the threat it poses to Islam. And his book strongly suggests that the best defense against terrorist groups like the Wahhabi sect in the future is anything people can do to end racism.
Author: Jim Keith
Publisher: Illuminet Press
ISBN: 9781881532217
Category : Political Science
Languages : en
Pages : 128
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Book Description
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.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309172128
Category : Technology & Engineering
Languages : en
Pages : 289
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Book Description
This book explores the risks and benefits of crops that are genetically modified for pest resistance, the urgency of establishing an appropriate regulatory framework for these products, and the importance of public understanding of the issues. The committee critically reviews federal policies toward transgenic products, the 1986 coordinated framework among the key federal agencies in the field, and rules proposed by the Environmental Protection Agency for regulation of plant pesticides. This book provides detailed analyses of: Mechanisms and results of genetic engineering compared to conventional breeding for pest resistance. Review of scientific issues associated with transgenic pest-protected plants, such as allergenicity, impact on nontarget plants, evolution of the pest species, and other concerns. Overview of regulatory framework and its use of scientific information with suggestions for improvements.
