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Libri in inglese > Medicina e Infermieristica > Medicina: argomenti di interesse generale > Attrezzature e tecniche mediche > Ricerca medica > Sperimentazioni cliniche > Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections

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

Name: Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections
Brand: John Wiley & Sons Inc
SKU: 04882483
Price: 95.39 EUR
Availability: InStock
Author: Vera Mihajlovic-Madzarevic
ISBN: 9780470248850

Vera Mihajlovic-Madzarevic

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Inglese

Libro Rigido

Codice Libristo: 04882483

Casa editrice John Wiley & Sons Inc, giugno 2010

All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applic... Descrizione completa

Codice Libristo: 04882483

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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.