Good Clinical Practices in Pharmaceuticals

Inbunden, Engelska, 2024

Av Graham P. Bunn, USA) Bunn, Graham P. (GB Consulting LLC, in Pennsylvania

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Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable.Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted.Provides the most up‑to‑date and best practices, techniques, and methodologies in good clinical practice.Discusses applicable laws and regulations supporting GCP compliance, quality and operations.Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.

Produktinformation

Utgivningsdatum2024-11-26
Mått156 x 234 x 16 mm
Vikt460 g
FormatInbunden
SpråkEngelska
SerieDrugs and the Pharmaceutical Sciences
Antal sidor194
FörlagTaylor & Francis Ltd
ISBN9781032524078

Tillhör följande kategorier

Tillverkningsteknik inom Naturvetenskap och teknik
Medicinsk utrustning och medicinska tekniker inom Medicin
Farmakologi inom Medicin
Biologi inom Naturvetenskap och teknik

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).

PrefaceAbout the EditorList of ContributorsIntroduction1 Regulatory Application Requirements Shanthi Ganeshan and Connie Freund2 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 Lawyer4 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 BoardsAurea Flores 9 Protected Health Information and Privacy in Clinical Trials (HIPAA) Sam Sather 10 Good Pharmacovigilance Practices (GVP) Jessica Chu11 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