Download or read book Enregistrement des produits de sant en Europe written by Catia Afonso and published by . This book was released on 2019 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les produits de santé mis à disposition des patients et des professionnels de santé sont multiples et d'une grande diversité. Néanmoins, quels que soient leur nature ou leur statut, ces produits doivent remplir certaines exigences règlementaires pour être conformes aux attentes des autorités de santé. Ainsi, avant d'être mis sur le marché, tout produit de santé doit obtenir le droit d'être commercialisé. Les produits répondant principalement aux trois critères « qualité », « sécurité » et « efficacité », se voient octroyer ces autorisations à l'issue de procédures réglementées et harmonisées en Europe. Ces autorisations se présentent sous la forme d'une Autorisation de Mise sur le Marché (AMM) pour les médicaments et du Marquage CE pour les Dispositifs Médicaux (DM). Ce sont ces deux statuts que nous développerons dans cette thèse. En effet, les médicaments et les DM sont issus de technologies et de processus de développement différents, ils sont donc réglementés au niveau Européen par des législations différentes et bien définies. Ainsi selon le statut, le développement, les essais à effectuer et le dossier d'enregistrement à rédiger répondent à des critères différents. L'anticipation de toutes ces étapes permet de multiplier les chances d'un aboutissement favorable et plus rapide de la procédure d'enregistrement. Or, l'évolution des connaissances et le développement de nouvelles thérapeutiques ont engendré la naissance de produits pour lesquels l'attribution d'un statut peut se révéler plus complexe. Le pharmacien industriel a donc un rôle central dans la préparation de l'attribution d'un statut réglementaire et des aspects juridiques liés.
Download or read book R glementations europ enne et marocaine des produits de sant written by Trong Nghia Tran and published by . This book was released on 2005 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'étude des textes réglementaires en Europe et au Maroc a permis de faire une analyse comparée des points communs et des différences entre les réglementations spécifiques de ces pays dans le cas des médicaments et des dispositifs médicaux. Ainsi, il existe deux types de procédures d'enregistrement des médicaments en Europe contre une seule au Maroc. La mise sur le marché d'un dispositif médical en Europe passe par une procédure de marquage CE tandis qu'au Maroc, la procédure d'enregistrement suit celle d'un médicament. Cependant, les réglementations marocaines demeurent largement inspirées des principes des réglementations européennes.
Download or read book Aid Activities in Europe and Oceania 2002 written by OECD and published by OECD Publishing. This book was released on 2004-06-25 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aid Activities in Europe and Oceania provides detailed information on individual foreign aid commitments, i.e. intended disbursements, of Official Development Assistance (ODA) and Official Aid (OA) to countries in Europe and Oceania for the year ...
Download or read book Conventions et accords europ ens written by Council of Europe and published by Council of Europe. This book was released on 1990-01-01 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Opposite pages bear duplicate numbering. Parallel texts in English & French. - Parallel title: Conventions et accords Europâens
Download or read book Aid Activities in Europe and Oceania 1998 1999 written by OECD and published by OECD Publishing. This book was released on 2000-08-07 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aid Activities in Europe and Oceania provides detailed information on individual commitments, i.e. intended disbursements, of Official Development Assistance (ODA) and Official Aid (OA) to countries in Europe and Oceania for the years 1998 and 1999 ...
Download or read book Aid Activities in Europe and Oceania 1999 2000 written by OECD and published by OECD Publishing. This book was released on 2001-09-25 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aid Activities in Europe and Oceania provides detailed information on individual commitments, i.e. intended disbursements, of Official Development Assistance (ODA) and Official Aid (OA) to countries in Europe and Oceania for the years 1999 and 2000 ...
Download or read book Aid Activities in Europe and Oceania 2001 2002 written by OECD and published by OECD Publishing. This book was released on 2003-10-02 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication provides detailed information on individual commitments, i.e. intended disbursements, of Official Development Assistance (ODA) and Official Aid (OA) to countries in Europe and Oceania for the years 2001 and 2002. This yearly ...
Download or read book European Yearbook 1986 written by P. Drillien and published by Martinus Nijhoff Publishers. This book was released on 1988-09-08 with total page 1064 pages. Available in PDF, EPUB and Kindle. Book excerpt: The European Yearbook promotes the scientific study of nineteen European supranational organisations and the OECD. Each volume contains a detailed survey of the history, structure and yearly activities of each organisation and an up-to-date chart providing a clear overview of the member states of each organisation.
Download or read book Yearbook of International Organizations 1992 93 written by Union of International Associations Staff and published by United Nations Publications. This book was released on 1992 with total page 1592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Yearbook of international organizations.- v. 3
Download or read book Aid Activities in Europe and Oceania 2003 written by OECD and published by OECD Publishing. This book was released on 2005-08-09 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aid Activities in Europe and Oceania provides detailed information on individual commitments, i.e. intended disbursements, of foreign aid to European and Oceanian countries for the year 2003. This yearly publication records the commitments reported ...
Download or read book Aid Activities in Europe and Oceania 1999 written by OECD and published by OECD Publishing. This book was released on 1999-06-07 with total page 83 pages. Available in PDF, EPUB and Kindle. Book excerpt: [Aid activities in Europe and Oceania] provides detailed information on individual commitments, [i.e.] intended disbursements, of Official Development Assistance (ODA) and Official Aid (OA) to countries in Europe and Oceania for the years 1997 and ...
Download or read book Aid Activities in South East Europe Creditor Reporting System 1990 1998 written by OECD and published by OECD Publishing. This book was released on 1999-09-29 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aid Activities in South-East Europe provides detailed information on individual commitments of Official Development Assistance (ODA) and Official Aid in the Balkan region for the years 1990-1998.
Download or read book Annuaire Europ en European Yearbook written by Council of Europe Staff and published by Springer Science & Business Media. This book was released on 2013-12-01 with total page 1002 pages. Available in PDF, EPUB and Kindle. Book excerpt: The "European Yearbook promotes the scientific study of nineteen European supranational organisations and the Organisation for Economic Co-operation and Development (OECD). Each volume contains a detailed survey of the history, structure and yearly activities of each organisation and an up-to-date chart providing a clear overview of the member states of each organisation. Each volume contains a comprehensive bibliography covering the year's relevant publications.
Download or read book EuroGuide written by Editions Delta and published by . This book was released on 2018-05-15 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1977, a unique reference source on European Union institutions. Part I explains how it functions. Part II consists in a directory of people in charge, with details.
Download or read book Private Enforcement of Competition Law in Europe written by Rafael Amaro and published by Bruylant. This book was released on 2021-06-10 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces the reader to key legal provisions and case-law related to the procedural and substantive issues that may arise in damages litigation for breach of anti-competitive agreements and abuses of a dominant position prohibitions. For the past decade, academic publications have focused on the proposal for a Directive on damages actions, then the Directive 2014/104/EU of 26 November 2014 itself, and finally the transposition texts. However, this understandable interest should not lead to overlook the fact that the Directive has been applied very little until now. This is mainly due to its application ratione temporis. In addition to the fact that Member States only transposed the Directive between the end of 2016 and 2018, Article 22 of the Directive provides that the substantive rules contained in the Directive cannot be applied to infringements subsequent to the national laws transposing them, while the procedural rules of the Directive apply to proceedings commenced on or after 26 December 2014. Thus, it is prior domestic law that continues to govern the vast majority of cases before national courts in the “Pre-Directive era.” In addition, a number of issues of the utmost importance have not been addressed by the Directive, such as questions of international jurisdiction or the quantification of “interests.” For these reasons, it seemed necessary not to limit this book to commenting on the Directive, important as it is, but to go beyond it. Directed by Rafael Amaro, this book contains the contributions from leading academics, attorneys, jurists and economists in the field of the private enforcement of competition law. It is composed of thematic chapters dealing with matters such as applicable law in international litigation, limitation, quantification of damages, from both a European Union and a national perspective, as well as national chapters presenting the state of play in several European States.
