Réglementation des produits dérivés des tissus et cellules d'origine humaine en Europe et aux Etats-Unis PDF Download
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Author: Sabrina Elmalem
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Book Description
L'émergence de nouvelles technologies a conduit à l'utilisation de produits dérivés de tissus et cellules d'origine humaine à des fins thérapeutiques, en particulier en orthopédie, dermatologie, oncologie et immunologie. Inquiétées par le nombre croissant de produits, les autorités de santé cherchent à renforcer et à rationaliser leur contrôle. Aux États-Unis, la FDA a créé un cadre réglementaire spécifique où le niveau d'exigences requis est proportionnel au niveau de risque présenté par le produit, classé en dispositif médical ou en médicament. En Europe, plusieurs initiatives ont été prises récemment à l'échelle communautaire. La législation pharmaceutique a été étendue aux produits répondant à la définition de thérapie cellulaire. La Commission européenne travaille sur deux directives séparées, l'une concernant l'obtention des tissus et les autres aspects liés aux banques de tissus, l'autre sur la fabrication et la mise sur le marché des produits dérivés des tissus. A toutes les étapes de ce processus, l'industrie est consultée et joue un rôle clé.
Author: Sabrina Elmalem
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Book Description
L'émergence de nouvelles technologies a conduit à l'utilisation de produits dérivés de tissus et cellules d'origine humaine à des fins thérapeutiques, en particulier en orthopédie, dermatologie, oncologie et immunologie. Inquiétées par le nombre croissant de produits, les autorités de santé cherchent à renforcer et à rationaliser leur contrôle. Aux États-Unis, la FDA a créé un cadre réglementaire spécifique où le niveau d'exigences requis est proportionnel au niveau de risque présenté par le produit, classé en dispositif médical ou en médicament. En Europe, plusieurs initiatives ont été prises récemment à l'échelle communautaire. La législation pharmaceutique a été étendue aux produits répondant à la définition de thérapie cellulaire. La Commission européenne travaille sur deux directives séparées, l'une concernant l'obtention des tissus et les autres aspects liés aux banques de tissus, l'autre sur la fabrication et la mise sur le marché des produits dérivés des tissus. A toutes les étapes de ce processus, l'industrie est consultée et joue un rôle clé.
Author: C. Melber
Publisher: WHO
ISBN:
Category : Medical
Languages : en
Pages : 154
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Book Description
On cover: IPCS International Programme on Chemical Safety. Published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organization and the World Health Organization, and produced within the framework of the Inter-organization Programme for the Sound Management of Chemicals (IOMC)
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309170435
Category : Nature
Languages : en
Pages : 241
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Book Description
Having safe drinking water is important to all Americans. The Environmental Protection Agency's decision in the summer of 2001 to delay implementing a new, more stringent standard for the maximum allowable level for arsenic in drinking water generated a great deal of criticism and controversy. Ultimately at issue were newer data on arsenic beyond those that had been examined in a 1999 National Research Council report. EPA asked the National Research Council for an evaluation of the new data available. The committee's analyses and conclusions are presented in Arsenic in Drinking Water: 2001 Update. New epidemiological studies are critically evaluated, as are new experimental data that provide information on how and at what level arsenic in drinking water can lead to cancer. The report's findings are consistent with those of the 1999 report that found high risks of cancer at the previous federal standard of 50 parts per billion. In fact, the new report concludes that men and women who consume water containing 3 parts per billion of arsenic daily have about a 1 in 1,000 increased risk of developing bladder or lung cancer during their lifetime.
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: Alan D. Lopez
Publisher: World Bank Publications
ISBN: 0821362631
Category : Medical
Languages : en
Pages : 511
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Book Description
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.
Author: Linda Strande
Publisher: IWA Publishing
ISBN: 1780404735
Category : Technology & Engineering
Languages : en
Pages : 428
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Book Description
It is estimated that literally billions of residents in urban and peri-urban areas of Africa, Asia, and Latin America are served by onsite sanitation systems (e.g. various types of latrines and septic tanks). Until recently, the management of faecal sludge from these onsite systems has been grossly neglected, partially as a result of them being considered temporary solutions until sewer-based systems could be implemented. However, the perception of onsite or decentralized sanitation technologies for urban areas is gradually changing, and is increasingly being considered as long-term, sustainable options in urban areas, especially in low- and middle-income countries that lack sewer infrastructures. This is the first book dedicated to faecal sludge management. It compiles the current state of knowledge of the rapidly evolving field of faecal sludge management, and presents an integrated approach that includes technology, management, and planning based on Sandecs 20 years of experience in the field. Faecal Sludge Management: Systems Approach for Implementation and Operation addresses the organization of the entire faecal sludge management service chain, from the collection and transport of sludge, and the current state of knowledge of treatment options, to the final end use or disposal of treated sludge. The book also presents important factors to consider when evaluating and upscaling new treatment technology options. The book is designed for undergraduate and graduate students, and engineers and practitioners in the field who have some basic knowledge of environmental and/or wastewater engineering.
Author: Bashford Dean
Publisher:
ISBN:
Category : Fishes
Languages : en
Pages : 750
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Book Description
Author: Philipp Fluri
Publisher: DCAF
ISBN: 8683543102
Category : Legislative oversight
Languages : en
Pages : 209
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Book Description
Author: Pascal Bonnet
Publisher: Editions Quae
ISBN: 2876143070
Category : Bactrian camel
Languages : fr
Pages : 318
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Book Description
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.
