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Author: Caroline Trouet
Publisher: Intersentia nv
ISBN: 9050954200
Category : Belgium
Languages : en
Pages : 288
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Book Description
In line with its strong position in clinical research, Belgium is one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the new law concerning experiments on the human person (May 7, 2004) reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research. pharma.be, the Belgian Pharmaceutical Industry Association, wants to contribute its part to research in Belgium by clarifying the practical implications of the new regulations. At its request, dr. iur. Caroline Trouet wrote an Operational Guidance, which analyses the new Belgian law from the perspective of the sponsor of a clinical trial, but addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials in the practical implementation of the new law, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added. The text is useful, both for study sponsors and for all other actors in the field of medical research and development such as members of ethics committees, physicians, pharmacists, administrators etc.; by those who have had access to the manuscript, it is already qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law.
Author: Caroline Trouet
Publisher: Intersentia nv
ISBN: 9050954200
Category : Belgium
Languages : en
Pages : 288
Get Book Here
Book Description
In line with its strong position in clinical research, Belgium is one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the new law concerning experiments on the human person (May 7, 2004) reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research. pharma.be, the Belgian Pharmaceutical Industry Association, wants to contribute its part to research in Belgium by clarifying the practical implications of the new regulations. At its request, dr. iur. Caroline Trouet wrote an Operational Guidance, which analyses the new Belgian law from the perspective of the sponsor of a clinical trial, but addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials in the practical implementation of the new law, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added. The text is useful, both for study sponsors and for all other actors in the field of medical research and development such as members of ethics committees, physicians, pharmacists, administrators etc.; by those who have had access to the manuscript, it is already qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law.
Author: Ulrich Magnus
Publisher: Walter de Gruyter
ISBN: 3866538898
Category : Law
Languages : en
Pages : 1001
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Book Description
The Brussels I Regulation is by far the most prominent cornerstone of the European law of international civil procedure. Every practitioner in the international field has to work with it - and its importance is still growing. The first edition of this full scale article-by-article commentary found a very warm reception. This new edition brings the book up to date, incorporating a host of developments in the four years since ist first appearance, combines in-depth analysis with a genuine and truly European perspective, authored by top experts from all over Europe, covers the jurisprudence of the ECJ and of the Member States, and integrates thorough discussion of the pending proposal for a Brussels Ibis Regulation. This truly European commentary offers invaluable guidance for lawyers, judges and academics throughout Europe.
Author: Marleen Brans
Publisher: Routledge
ISBN: 131799003X
Category : Political Science
Languages : en
Pages : 250
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Book Description
For too long Belgium remained an unexplored terrain by comparative political scientists. Belgium's politics were best known through the writings of Arend Lijphart, who considered it a model case of consociationalism. Over the past ten to fifteen years, the analysis of consociationalism has been complemented by a more detailed coverage of Belgium's spectacular transformation process from a unitary into a federal state, moving rapidly now to disintegration. Likewise, several peculiar aspects of Belgian politics, such as the record fragmentation of its party system, have been covered in edited volumes or international journals. However, given the complexity of the Belgian configuration of political institutions and actors, any inclusion of particular aspects of the Belgian case in comparative work calls for an in depth and integrated understanding of the broader political system. This is the first book which provides such an analysis. It brings together a team of 19 political scientists and sociologists who aim to explain the dynamics and incentives of institutional change and seek to analyze the intricate interplay between the main institutional components of the Belgian body politic. The sociological, political and institutional determinants and the consequences of the "federalisation" process of Belgium is the central theme that links each of the individual chapters. This book will be essential reading for students who want to understand the politics of Belgium and for anyone with a strong interest in West European Politics, comparative politics and comparative federalism. This book was published as a special issue of West European Politics.
Author: Demetrius Charles Boulger
Publisher:
ISBN:
Category : Belgium
Languages : en
Pages : 304
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Book Description
Author: Jean-Michel Detry
Publisher: Kluwer Law International B.V.
ISBN: 9041190074
Category : Law
Languages : en
Pages : 203
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Book Description
Derived from Kluwer’s multi-volume Corporate Acquisitions and Mergers, the largest and most detailed database of M&A know-how available anywhere in the world, this work by a highly experienced partner in the leading international law firm DLA Piper provides a concise, practical analysis of current law and practice relating to mergers and acquisitions of public and private companies in Belgium. The book offers a clear explanation of each step in the acquisition process from the perspectives of both the purchaser and the seller. Key areas covered include: structuring the transaction; due diligence; contractual protection; consideration; and the impact of applicable company, competition, tax, intellectual property, environmental and data protection law on the acquisition process. Corporate Acquisitions and Mergers is an invaluable guide for both legal practitioners and business executives seeking a comprehensive yet practical analysis of mergers and acquisitions in Belgium. Equivalent analyses of M&A law and practice in some 50 other jurisdictions, all contributed by leading law firms, are accessible on-line at www.kluwerlawonline.com. under Corporate Acquisitions and Mergers.
Author:
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Category : Marketing
Languages : en
Pages : 44
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Book Description
Author: E. Lauterpacht
Publisher: Cambridge University Press
ISBN: 9780521463911
Category : Law
Languages : en
Pages : 564
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Book Description
International Law Reports is the only publication in the world wholly devoted to the regular and systematic reporting in English of courts and arbitrators, as well as judgements of national courts.
Author:
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Category : Commerce
Languages : en
Pages : 738
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Book Description
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Category : United States
Languages : en
Pages : 662
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Category : Customs administration
Languages : en
Pages : 960
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