Pharma Should Include ‘Heterogeneous Health Data’ In EU Regulatory & HTA Dossiers

Real-world data collected from a wide range of sources, such as wearable devices and public databases, can be used by pharmaceutical companies to boost their marketing authorization and health technology assessment applications, a regulatory policy expert from Sanofi says.

Rebecca Lumsden speaking at the RAPS Euro Convergence 2024
Rebecca Lumsden speaking at the RAPS Euro Convergence 2024 • Source: Pink Sheet

The European Commission has indicated a “strong intent” to take real-world evidence and “broader health care data” into greater consideration during regulatory and HTA decision-making in the future, according to Rebecca Lumsden, Sanofi’s head of regulatory science & policy, EU/AMEE regions.

During a presentation at the RAPS Euro Convergence meeting on 7 May, Lumsden outlined the potential for companies to use...

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