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

Language EnglishEnglish
Book Hardback
Book Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections Vera Mihajlovic-Madzarevic
Libristo code: 04882483
Publishers John Wiley & Sons Inc, June 2010
All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applic... Full description
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All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company 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.

About the book

Full name Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections
Author Vera Mihajlovic-Madzarevic
Language English
Binding Book - Hardback
Date of issue 2010
Number of pages 246
EAN 9780470248850
ISBN 0470248858
Libristo code 04882483
Publishers John Wiley & Sons Inc
Weight 490
Dimensions 156 x 234 x 16

Categories

Medicine & Nursing > Medicine: general issues > Medical equipment & techniques > Medical research > Clinical trials
Medicine & Nursing > Medical specialties, branches of medicine > Pharmacology
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