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This book provides a thorough reference on Good Clinical Practice (GCP) which is the international ethical, scientific and practical standard to which all clinical research is conducted.
List of contents
Preface
About the Editor
List of Contributors
Introduction
1 Regulatory Application Requirements
Shanthi Ganeshan and Connie Freund
2
John Klein and Sonya Edgerton
3
Sam Sather and Jennifer Lawyer
4 and Sonya Edgerton
5
Karen Truhe
6 21 CFR 50 - Informed Consent
Joe Near
7
Glenda Guest
8
Aurea Flores
9 Protected Health Information and Privacy in Clinical Trials (HIPAA)
Sam Sather
10 Good Pharmacovigilance Practices (GVP)
Jessica Chu
11 Data Integrity and 21CFR11 for GCPs
Randall Basinger
12 Preparing for FDA inspections at sponsor/investigator sites
Tommy Lee and Sam Sather
13 Regulations relating to the Placebo response in Clinical research
Graham Bunn and Arthur Ooghe
About the author
Graham P. Bunn has been the president of GB Consulting LLC, in Pennsylvania, since 2000 and provides regulatory compliance guidance and technical consulting services for pharmaceutical, biotechnology, and other FDA¿related industries. His experience includes supporting and leading teams for quality systems assessments, regulatory action responses and remediations (FDA483, Warning Letter, Consent Decree), and preparing sites to host regulatory inspections. He has developed and facilitated numerous highly interactive learning workshops worldwide, including Aseptic Training Programs, Batch Record Reviews, QA on the Floor, and aseptic training support for Compounding Centers. Before founding GB Consulting LLC, Graham gained extensive experience through various management positions in the pharmaceutical industry with SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career includes management responsibilities as a corporate compliance auditor, quality assurance, validation, and clinical trials manufacturing and packaging. Graham is the editor of Good Manufacturing Practices for Pharmaceuticals and Good Laboratory Practices for Non¿Clinical Studies and the author of several book chapters/journal articles. Graham received a BSc in pharmacy from Brighton University, England, and an MSc in Quality Assurance and Regulatory Affairs from Temple University, Philadelphia, and is a member of the Regulatory Affairs Professional Society (RAPS).
Summary
This book provides a thorough reference on Good Clinical Practice (GCP) which is the international ethical, scientific and practical standard to which all clinical research is conducted.
