FDA GCP Inspection Trends Identified Using AI

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  • Опубликовано: 16 сен 2024
  • FDA GCP Inspection Trends Identified Using AI
    Presented Tuesday, June 14, 2022
    Watch this informative 1-hour presentation with insights into FDA GCP inspection trends, including intelligence on data integrity and clinical investigator enforcement activity.
    Speakers:
    Jerry Chapman, Redica Systems
    Fran Lambetecchio, Regulatory Associates
    What is covered:
    - Importance and challenges of human clinical studies
    - Data sources and evaluation using AI Tools
    - What we can learn from US FDA Inspections of Clinical Investigators
    - A deeper dive into FDA Warning Letters and 483 data with some surprises

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