Téléchargez le livre : Clinical Trials Audit Preparation

Clinical Trials Audit Preparation

A Guide for Good Clinical Practice (GCP) Inspections

de

Éditeur :

Wiley


Paru le : 2011-03-01



eBook Téléchargement DRM Adobe 🛈
116,00 €
Téléchargement immédiat
Dès validation de votre commande
Ajouter à ma liste d'envies
Image Louise Reader présentation

Louise Reader

Lisez ce titre sur l'application Louise Reader.

badge apple Application Louise Reader
badge Android Application Louise Reader
Description
A must-have guide for any professional in the drug manufacturing industry
The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.
This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.
Among the topics discussed:
Good Clinical Practices and therapeutic product development in clinical research
The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee
The roles and responsibilities of the clinical trial investigator
The inspection preparation
The Audit Report and the Form 483
Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Pages
272 pages
Collection
n.c
Parution
2011-03-01
Marque
Wiley
EAN papier
9780470248850
EAN PDF
9780470572740
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
272
Taille du fichier
1905 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
116,00 €

Suggestions personnalisées