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Non-Interventional ≠ Not Interventional: Regulatory perspectives for real-world studies

Related topics: Medical Affairs & Stakeholder Engagement, Real-World Evidence & Late-Phase Research, Global (non-specific), Regulations & Ethics, Life Sciences (not-specific)

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Overview
  • Regulatory classification of real-world studies.
  • Why are the regulations for non-interventional studies so difficult/frustrating/confusing?
  • Pragmatic clinical trials: The missing RWE link?
Speaker

Stuart McCully
VP Late Stage
INC Research/inVentiv Health, UK

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This is the presenters’ personal opinion and does not necessarily represent true facts, the official views or policy of their organisation, nor the views of NextLevel Life Sciences.

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