Isbn: 9780470248850 - clinical trials audit preparation: a guide for good clinical practice (gcp) inspections (10 Ergebnisse)

Hardback. Zustand: Very Good. 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.…

Hardback. Zustand: Good. 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.…

HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

Zustand: Good. This is an ex-library book and may have the usual library/used-book markings inside.This book has hardback covers. In good all round condition. No dust jacket. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,600grams, ISBN:9780470248850. …

Zustand: New. In English.

Zustand: New. pp. xxi + 246 Illus.

Hardcover. Zustand: Brand New. 1st edition. 246 pages. 9.75x6.50x0.75 inches. In Stock.

Zustand: New. VERA MIHAJLOVIC-MADZAREVIC has more than twenty years of experience in scientific and clinical research in the academia and industry. She is the Director of Global Research Pharma Canada. She conducts Good Clinical Practice (GCP) audits for the pharmaceutic.

Zustand: New. 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. Num Pages: 246 pages, Illustrations. BIC Classification: MBGR1. Category: (P) Professional & Vocational. Dimension: 239 x 166 x 21. Weight in Grams: 560. . 2010. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.…

Buch. Zustand: Neu. Neuware - A must-have guide for any professional in the drug manufacturing industryThe 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.…