Author: PASCALE.. NEBOUTPublisher:
ISBN:
Category :
Languages : fr
Pages :
Book Description
APPLICATION DES BONNES PRATIQUES CLINIQUES
Author: PASCALE.. NEBOUTComparaison des bonnes pratiques cliniques avec la norme ISO 14155 sur les dispositifs médicaux et application aux documents qualité des essais cliniques des dispositifs médicaux au sein d'un laboratoire pharmaceutique
Author: Amélie CaneparoGuide pratique des bonnes pratiques cliniques à l'usage des investigateurs
Author: David R. HutchinsonPublisher:
ISBN: 9781874409106
Category : Clinical medicine
Languages : fr
Pages : 21
Book Description
Bonnes pratiques cliniques en Europe
Author: Publisher:
ISBN: 9781873292051
Category : Clinical trials
Languages : fr
Pages : 90
Book Description
Essais cliniques
Author: Agnès DantierGood Practice of Clinical Drug Trials
Author: Alain SprietPublisher: LIBRAIRIE LUGINBUHL
ISBN: 9783805577243
Category : Medical
Languages : en
Pages : 294
Book Description
This new edition of `Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: - Rationale for each rule presented - Safety of data in clinical trials - Protection of personal data - Conflicts of interest - Measures to be taken in case of suspected fraud
Bonnes pratiques cliniques
Author: BONNES PRATIQUES CLINIQUES ET PROCEDURES REGLEMENTAIRES DANS LA REALISATION D'ESSAIS CLINIQUES
Author: SOPHIE.. ABADIEClinical Trials in Belgium
Author: Caroline TrouetPublisher: Intersentia nv
ISBN: 9050954200
Category : Belgium
Languages : en
Pages : 288
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.
BONNES PRATIQUES CLINIQUES
Author: VERONIQUE.. NYS TOURNIERPublisher:
ISBN:
Category :
Languages : fr
Pages :
Book Description