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

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Opis

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.

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Kategoria Książki po angielsku Medicine Medicine: general issues Medical equipment & techniques

• Pełny tytuł: Clinical Trials Audit Preparation - A Guide for Good Clinical Practice (GCP) Inspections
• Autor: Vera Mihajlovic-Madzarevic
• Język: Angielski
• Oprawa: Twarda
• Liczba stron: 246
• EAN: 9780470248850
• ISBN: 0470248858
• ID: 04882483
• Wydawca: John Wiley & Sons Inc
• Waga: 490 g
• Wymiary: 234 × 156 × 16 mm
• Data wydania: 18. June 2010

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