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Deliverable 3.1 (April 2017) Report On Feedback From EMA On Design Of Diagnostic Study.pdf

D3.1-AMYPAD.pdf
Preview of Deliverable 3.1 (April 2017) Report on feedback from EMA on design of diagnostic study
🔗 Source: amypad.eu
📊 Size: 454 KB
👤 Author: Knox, Sean
⬇️ Downloads: 51

Summary

The AMYPAD project received scientific advice from the European Medicines Agency (EMA) and HTA authorities on the design of a diagnostic study, which started with a preliminary conference call in August and a face-to-face meeting on October 26. The EMA's feedback led to updates in the study design to align with regulatory expectations, aiming to increase the potential value of real-world evidence on amyloid PET imaging's impact on diagnostic thinking, patient management, and medical resource use in 900 patients over five years.

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The AMYPAD project received scientific advice from the European Medicines Agency (EMA) and HTA authorities on the design of a diagnostic study, which started...

Technical Information

  • File Format: PDF
  • File Size: 454 KB
  • Pages: 1
  • Language: EN
  • Author: Knox, Sean
  • Total Downloads: 51
  • Last Updated: 1 month ago

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