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.
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.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
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).
Inhaltsangabe
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
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
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