Читайте только на Литрес

The book cannot be downloaded as a file, but can be read in our app or online on the website.

Основной контент книги Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections
Text PDF

Volume 270 pages

0+

Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections

author
vera mihajlovic-madzarevic
Читайте только на Литрес

The book cannot be downloaded as a file, but can be read in our app or online on the website.

$131.94

About the book

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

Genres and tags

Log in, to rate the book and leave a review
Book Vera Mihajlovic-Madzarevic «Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections» — read online on the website. Leave comments and reviews, vote for your favorites.
Age restriction:
0+
Release date on Litres:
31 March 2018
Volume:
270 p.
ISBN:
9780470572740
Total size:
1.9 МБ
Total number of pages:
270
Copyright holder:
John Wiley & Sons Limited
Audio
Средний рейтинг 4,2 на основе 1003 оценок
Text, audio format available
Средний рейтинг 4,6 на основе 37 оценок
Draft
Средний рейтинг 4,9 на основе 176 оценок
Text
Средний рейтинг 4,9 на основе 287 оценок
Audio
Средний рейтинг 3,7 на основе 9 оценок
Audio
Средний рейтинг 4,8 на основе 5206 оценок
Text, audio format available
Средний рейтинг 4,7 на основе 1810 оценок
Text, audio format available
Средний рейтинг 4,7 на основе 7153 оценок
Audio
Средний рейтинг 4,8 на основе 710 оценок
Text, audio format available
Средний рейтинг 4,9 на основе 161 оценок
Text PDF
Средний рейтинг 0 на основе 0 оценок