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4th European Clinical Quality Risk Management Forum
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Monday, February 24 • 1:15pm - 2:00pm
Compare and Contrast Inspections by Different Agencies

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Examine the Differences in the Conduct of Inspections by Different Regulatory Agencies and the Impact on Inspection Ready Processes 
  • Explore the largest differences in inspection duration, number of inspectors, practicalities and logistics between agencies when conducting sponsor and investigator site inspections
    • Outside of the main inspectorates/markets, insight into special practices of local authorities
  • Understand how inspection preparation activities should change depending on the agency
  • Review relevant guidance documents, most notably ICH E6 R2, and how they can be used to support preparation activities

Speakers
avatar for Heike Reinstaedtler

Heike Reinstaedtler

Head, Clinical and Medical Quality, GSK VACCINES
Heike serves as Head of Clinical and Medical Quality at GSK Vaccines, a global team responsible for quality oversight and support enabling proactive, integrated and risk-based quality management throughout the clinical and epidemiology study processes. Her focus is to partner with... Read More →


Monday February 24, 2020 1:15pm - 2:00pm