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Více informací o knize Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections

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Anotace knihy

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.

Parametry knihy

Zařazení knihy Knihy v angličtině Medicine Medicine: general issues Medical equipment & techniques

• Plný název: Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections
• Autor: Vera Mihajlovic-Madzarevic
• Jazyk: Angličtina
• Vazba: Pevná
• Počet stran: 246
• EAN: 9780470248850
• ISBN: 0470248858
• ID: 04882483
• Nakladatelství: John Wiley & Sons Inc
• Hmotnost: 490 g
• Rozměry: 234 × 156 × 16 mm
• Datum vydání: 18. June 2010

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