Modification du contexte réglementaire appliqué à l'évaluation clinique : analyse du changement et proposition de méthodologie d'intégration dans la fonction assurance qualité PDF Download
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Author: Laurence Bareau
Publisher:
ISBN:
Category :
Languages : fr
Pages : 210
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Book Description
La Directive Européenne 2001/20/CE relative à !'application des Bonnes Pratiques Cliniques va permettre une harmonisation des essais cliniques au sein de l'Europe et une standardisation des dossiers facilitant ainsi les essais multicentriques. Elle impliquera donc une revue de la loi Huriet-Sérusclat régissant les essais cliniques en France. Les principaux changements concerneront les comités d'éthique, le système d'information, la procédure de soumission du dossier d'essai clinique, la suppression de la distinction entre la recherche avec et sans Bénéfice Individuel Direct et enfin la clarification des règles de protection des personnes participant à la recherche biomédicale. Un service Assurance Qualité face à une modification de réglementation devra mettre en place une démarche Assurance Qualité afin de mettre à jour les processus et les procédures et de former le personnel. Dans cette optique et en considérant l'importance grandissante des activités en projet, les entreprises pourraient appliquer la méthode de management par projet.
Author: Laurence Bareau
Publisher:
ISBN:
Category :
Languages : fr
Pages : 210
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Book Description
La Directive Européenne 2001/20/CE relative à !'application des Bonnes Pratiques Cliniques va permettre une harmonisation des essais cliniques au sein de l'Europe et une standardisation des dossiers facilitant ainsi les essais multicentriques. Elle impliquera donc une revue de la loi Huriet-Sérusclat régissant les essais cliniques en France. Les principaux changements concerneront les comités d'éthique, le système d'information, la procédure de soumission du dossier d'essai clinique, la suppression de la distinction entre la recherche avec et sans Bénéfice Individuel Direct et enfin la clarification des règles de protection des personnes participant à la recherche biomédicale. Un service Assurance Qualité face à une modification de réglementation devra mettre en place une démarche Assurance Qualité afin de mettre à jour les processus et les procédures et de former le personnel. Dans cette optique et en considérant l'importance grandissante des activités en projet, les entreprises pourraient appliquer la méthode de management par projet.
Author:
Publisher: UNESCO
ISBN: 9230010871
Category :
Languages : en
Pages : 209
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Book Description
Author: Philip G. Altbach
Publisher: BRILL
ISBN: 9004406158
Category : Education
Languages : en
Pages : 270
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Book Description
Today’s academic revolution is unprecedented. Mass higher education has become a worldwide phenomenon, with enrollments growing from 100 million to 150 million in just a decade. The implications of massification are immense—greatly increased participation for a more diverse population including women and many traditionally underrepresented socio-economic groups; the rise of private higher education; diversification of academic institutions and systems; and an overall weakening of academic standards at non-elite institutions in many countries. At the same time, higher education is recognized as a key driver of the new knowledge economy. Because of this research universities, at the top of academic systems, have become central institutions in contemporary society. Trends in Global Higher Education analyses these and other key forces shaping higher education today. Using up-to-date UNESCO statistics, trends defining higher education are placed in a comparative and international framework. Patterns of globalization, the flow of students and scholars across borders, the impact of information technology, and other key forces are critically assessed. This book is a key resource for understanding the present and future of global higher education.
Author:
Publisher: UNICEF
ISBN: 9280643762
Category : Business & Economics
Languages : en
Pages : 244
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Book Description
This Child-Friendly Schools (CFS) Manual was developed during three-and-a-half years of continuous work, involving the United Nations Children's Fund education staff and specialists from partner agencies working on quality education. It benefits from fieldwork in 155 countries and territories, evaluations carried out by the Regional Offices and desk reviews conducted by headquarters in New York. The manual is a part of a total resource package that includes an e-learning package for capacity-building in the use of CFS models and a collection of field case studies to illustrate the state of the art in child-friendly schools in a variety of settings.
Author: Sven Boermeester
Publisher:
ISBN: 9781949677072
Category :
Languages : en
Pages :
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Book Description
Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.
Author: Food and Agriculture Organization of the United Nations
Publisher: Fao Technical Guidelines for R
ISBN:
Category : Business & Economics
Languages : en
Pages : 96
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Book Description
"These guidelines have been produced to supplement as an addition to the FAO Technical Guidelines for Responsible Fisheries no. 4, Suppl. 2 entitled Fisheries management".
Author: World Bank;World Trade Organization
Publisher: World Bank Publications
ISBN: 1464815569
Category : Business & Economics
Languages : en
Pages : 270
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Book Description
Trade can dramatically improve women’s lives, creating new jobs, enhancing consumer choices, and increasing women’s bargaining power in society. It can also lead to job losses and a concentration of work in low-skilled employment. Given the complexity and specificity of the relationship between trade and gender, it is essential to assess the potential impact of trade policy on both women and men and to develop appropriate, evidence-based policies to ensure that trade helps to enhance opportunities for all. Research on gender equality and trade has been constrained by limited data and a lack of understanding of the connections among the economic roles that women play as workers, consumers, and decision makers. Building on new analyses and new sex-disaggregated data, Women and Trade: The Role of Trade in Promoting Gender Equality aims to advance the understanding of the relationship between trade and gender equality and to identify a series of opportunities through which trade can improve the lives of women.
Author: Canada. Industry Canada
Publisher:
ISBN:
Category : Language Arts & Disciplines
Languages : en
Pages : 56
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Book Description
Author: Bihini won wa Musiti
Publisher: IUCN
ISBN: 2831706904
Category : Conservation of natural resources
Languages : ru
Pages : 344
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Book Description
This bilingual publication results from a four-day symposium aimed at capturing the general directions and analytical issues that characterize approaches to sustainable use in Africa. The papers included in this work are organized under four major headings: modes of use, devolution, scale issues and external issues. Authors explore these themes through the use of case studies and the description of specific regional experiences. External issues are further explored in a series of commissioned policy papers which have also been included.
Author: Tiago Carneiro Peixoto
Publisher:
ISBN: 9780996414227
Category :
Languages : en
Pages :
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Book Description
