Good Clinical Practices in Pharmaceuticals

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, 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).

Preface
About the Editor
List of Contributors
Introduction

1 Regulatory Application Requirements
Shanthi Ganeshan and Connie Freund

2 An overview of Good Clinical Practices
John Klein and Sonya Edgerton

3 Quality by Design, Critical to Quality Factors - ICH E8 (R1)
Sam Sather and Jennifer Lawyer

4 Good Clinical Practice ICH E6 (R2 and R3)
John Klein and Sonya Edgerton

5 Clinical Safety Data Management ICH E2A
Karen Truhe

6 21 CFR 50 – Informed Consent
Joe Near

7 21 CFR 54 – Financial Disclosure
Glenda Guest

8 21 CFR 56 – Institutional Review Boards
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