18.11.2025

Why prepare a consolidated assumed assessment scope?

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🔧 PART 8: Why prepare a consolidated assumed assessment scope❓️

Series: monthly news from the EU HTA workshop

 

🌍 The European Commission will share the consolidated assessment scope with your first request. Your scope serves a triple purpose:

 

🎯 It provides you with an early working hypotheses on the PICOs, so that you can prepare accordingly by drafting the relevant dossier sections.

🎯 National PICOs are subject to change. That‘s why the PICO survey will most likely be repeated during your dossier preparation. The more transparent your documentation on how consolidated PICOs are reached, the easier and more efficient it become to update them later – without missing important details. It also helps in case you ask external experts for validation of your PICO scoping and consolidation 😉.

🎯 The first request by the Coordination Group is the "moment of truth". Use the consolidated assumed assessment scope as a benchmark to check the (official) consolidated assessment scope. You will need it for the assessment scope explanation meeting.

 

Looking for a shortcut❓️

👥 Our working group here at Ecker +  Ecker is happy to help you putting together your consolidated assumed assessment scope for your product in preparation for EU HTA.