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FIRESIDE CHAT: A Regulators View – Insights from the FDA/MHRA/EMA

11 Sep 2019
9:00am-9:45am

FIRESIDE CHAT: A Regulators View – Insights from the FDA/MHRA/EMA

  • This session will give insights into ensuring inspection ready, compliant, accurate and timely TMF documentation from the point of view of those responsible for regulating clinical trials in the United States and beyond.
    • Important regulatory updates
    • Audit trails
    • Certified copies
    • Draft documents
    • Process
    • TMF study index
    • International alignment in inspections between FDA, EMA, PMDA and MHRA
          • Co inspections/shared inspections – how do they work?