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B01=Graham P. Bunn
Category1=Non-Fiction
Category=MMG
Category=PN
Category=PS
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COP=United Kingdom
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Good Clinical Practices in Pharmaceuticals

★★★★★
★★★★★

English

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.

  1. Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted.
  2. Provides the most uptodate and best practices, techniques, and methodologies in good clinical practice.
  3. Discusses applicable laws and regulations supporting GCP compliance, quality and operations.
  4. 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.
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€107.34
€112.99
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Age Group_Uncategorizedautomatic-updateB01=Graham P. BunnCategory1=Non-FictionCategory=MMGCategory=PNCategory=PSCategory=TDCWCOP=United KingdomDelivery_Pre-orderLanguage_EnglishPA=Not yet availablePrice_€100 and abovePS=Forthcomingsoftlaunch

Will deliver when available. Publication date 02 Dec 2024

Product Details
  • Dimensions: 156 x 234mm
  • Publication Date: 02 Dec 2024
  • Publisher: Taylor & Francis Ltd
  • Publication City/Country: United Kingdom
  • Language: English
  • ISBN13: 9781032524078

About

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 FDArelated 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 NonClinical 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).

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