Caroline Trouet's Books

Clinical Trials in Belgium

The Implementation of the European Clinical Trials Directive 2001/20/EC Into the Belgian Law of May 7, 2004 Concerning Experiments on the Human Person : Operational Guidance

By: Caroline Trouet

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Clinical Trials in Belgium

The Implementation of the European Clinical Trials Directive 2001/20/EC Into the Belgian Law of May 7, 2004 Concerning Experiments on the Human Person : Operational Guidance

By: Caroline Trouet

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.

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Page Count

288

Publisher

Intersentia nv

Published Date

ISBN 10

9050954200

ISBN 13

9789050954204

Cultivating the City in Early Medieval Italy

By: Caroline Goodson

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Cultivating the City in Early Medieval Italy

By: Caroline Goodson

Concentrating on a period of social, economic, and political change in the Italian peninsula, Caroline Goodson demonstrates the centrality of food-growing gardens to the cultural lives and economic realities of early medieval cities, and shows how urban gardening transformed Roman ideas and economic structures into new, medieval values.

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Page Count

323

Publisher

Cambridge University Press

Published Date

ISBN 10

1108802273

ISBN 13

9781108802277

Clinical Trials in Belgium

The Implementation of the European Clinical Trials Directive 2001/20/EC Into the Belgian Law of May 7, 2004 Concerning Experiments on the Human Person : Operational Guidance

By: Caroline Trouet

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Clinical Trials in Belgium

The Implementation of the European Clinical Trials Directive 2001/20/EC Into the Belgian Law of May 7, 2004 Concerning Experiments on the Human Person : Operational Guidance

By: Caroline Trouet

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N/A

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Solve jigsaw puzzle

Age

Page Count

288

Publisher

Intersentia nv

Published Date

ISBN 10

9050954200

ISBN 13

9789050954204

Clinical Trials in Belgium

The Belgian Implementation of the European Clinical Trials Directives

By: Caroline Trouet,Marjorie Gobert,Monique Podoor

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Clinical Trials in Belgium

The Belgian Implementation of the European Clinical Trials Directives

By: Caroline Trouet,Marjorie Gobert,Monique Podoor

In line with its strong position in clinical research, Belgium was 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 legislation concerning experiments on the human person 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. This new edition of the Operational Guidance does not only analyse the Belgian law from the perspective of the sponsor of a clinical trial, but also addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials, 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 on a cd rom. This book is extremely 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. The first edition of Clinical Trials in Belgium was very soon qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law.

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Page Count

289

Publisher

Intersentia Uitgevers N V

Published Date

ISBN 10

9050956874

ISBN 13

9789050956871

Book's by Caroline Trouet

Clinical Trials in Belgium

Clinical Trials in Belgium

Cultivating the City in Early Medieval Italy

Cultivating the City in Early Medieval Italy

Clinical Trials in Belgium

Clinical Trials in Belgium

Clinical Trials in Belgium

Clinical Trials in Belgium

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