Clinical Trials in Belgium: The Belgian implementation of the European Clinical Trials Directives : An operational guidance. Update 2007 [printed text] / Caroline Trouet, Author ; Marjorie Gobert, Author ; Monique Poddor . - 2nd. . - Antwerpen : Intersentia : Brussel [Belgium] : Pharma.be, 2007 . - xxxvi, 289 p. + 1 CD ROM. ISBN : 978-90-5095-687-1 : € 76,00 Languages : English ( eng)
| Descriptors: |
Classification
QV 771 Standardization and evaluation of drugs
Indexation
Belgium ; Clinical Trials ; European Union
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| Abstract: |
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. |
| Contents note: |
Introduction: European Clinical Trials Directives and Belgian legal framework -- PART I. Scope of the Belgian legal framework -- PART II. The Different players -- PART III. Protection of subjects participating in experiments -- PART IV. The role of the ethics committee(s) -- PART V. Procedures for conducting a clinical trial in Belgium -- PART VI. Investigational Medicinal Products -- PART VII. Special cases: Non-interventional trials, non-commercial experiments and paediatric clinical trials -- PART VIII. Sanctions -- Conclusion
Online addendum http://www.intersentia.com/Files/Books/Booksannexes/9789050956871_1.pdf |
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