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Clinical Trials in Belgium: The Belgian implementation of the European Clinical Trials Directives / Caroline Trouet / Antwerpen : Intersentia (2007)
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 UnionAbstract: 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.pdfRecord link: https://kce.docressources.info/index.php?lvl=notice_display&id=1418 Hold
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Barcode Call number Media type Location Section Status 10273-01570 QV 771/TRO Book KCE Library (10.124) Due for return by 12/15/2023 Readers who borrowed this document also borrowed:
Eléments du droit de la fonction publique Lombaert, Bruno Actualités en droit public et administratif Belleflamme, François Memento social 2012-02 (01/12/2012) van Eeckoutte, Willy Droit de la fonction publique à l'aune du droit européen Gosselin, F. Memento social 2010-02 (01/12/2010) van Eeckoutte, Willy Nouvelle réglementation relative à l'indemnisation des dommages résultant de soins de santé. Derèse, Marie-Noelle La protection des données médicales. Les défis du XXIe siècle Beyleveld, Deryck Code de droit médical et biomédical Derèse, Marie-Noelle Droit médical Leleu, Yves-Henri Memento social 2009-01 (01/06/2009) van Eeckoutte, Willy Droit et contentieux de la fonction publique Lombaert, Bruno Compendium 2005 [NL] / Brussel [Belgium] : Pharma.be (2005)
Compendium 2005 [NL] [printed text] . - 22ste . - Brussel [Belgium] : Pharma.be, 2005 . - xvci, 2826 p., 22 index : index ; 28 cm.
Languages : Dutch (dut)
Descriptors: Classification
QV 13 Pharmacology. Dictionaries. Encyclopedias
Indexation
Dictionaries, PharmaceuticRecord link: https://kce.docressources.info/index.php?lvl=notice_display&id=437 Hold
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Barcode Call number Media type Location Section Status 10273-00586 QV 13/COM Compendium KCE Library (10.124) Available Compendium 2006 [NL] / Brussel [Belgium] : Pharma.be (2006)
Compendium 2006 [NL] [printed text] . - 24ste . - Brussel [Belgium] : Pharma.be, 2006 . - xcv, 2767 p., 20 index : index ; 28 cm.
Languages : Dutch (dut)
Descriptors: Classification
QV 13 Pharmacology. Dictionaries. Encyclopedias
Indexation
Dictionaries, PharmaceuticRecord link: https://kce.docressources.info/index.php?lvl=notice_display&id=1829 Hold
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Barcode Call number Media type Location Section Status 10237-01762 QV 13/COM Compendium KCE Library (10.124) Available
e-COMPENDIUM [electronic document] . - Brussel [Belgium] : Pharma.be, 2008.
Mise à jour Quotidienne
Languages : French (fre)
Descriptors: Classification
QV 13 Pharmacology. Dictionaries. Encyclopedias
Indexation
Databases, Web ; Dictionaries, Pharmaceutic ; Dose-Response Relationship, Drug ; Pharmaceutical PreparationsContents note: * Les notices scientifiques originales des médicaments à usage humain et Vétérinaire.
* Les résumés des notices scientifiques, rédigés en collaboration avec l'Ecole de Santé Publique de l'Université Libre de Bruxelles (ULB).
* Le prix et des informations de remboursement actuel des medicaments.Link for e-copy: http://www.e-compendium.be/ Format of e-copy: Online Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1823
e-COMPENDIUM [electronic document] . - Brussel [Belgium] : Pharma.be, 2008.
dagelijk update
Languages : Dutch (dut)
Descriptors: Classification
QV 13 Pharmacology. Dictionaries. Encyclopedias
Indexation
Databases, Web ; Dictionaries, Pharmaceutic ; Dose-Response Relationship, Drug ; Pharmaceutical PreparationsContents note: * De originele wetenschappelijke bijsluiters van geneesmiddelen voor humaan en diergeneeskundig gebruik.
* Samenvattingen van de wetenschappelijke bijsluiters, opgesteld i.s.m. de Ecole de Santé Publique van de Université Libre de Bruxelles (ULB).
* Actuele prijs-en terugbetalingsinformatie van de geneesmiddelen.
Link for e-copy: http://www.e-compendium.be/ Format of e-copy: Online Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1824