US EditionEMA updates reflection paper on RWD in regulatory studies - Fondazione Gianni Benzi Onlus
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EMA updates reflection paper on RWD in regulatory studies - Fondazione Gianni Benzi Onlus
Following public consultation, the EMA has finally published its Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes, providing clearer guidance on regulatory expectations and methodological standards. Key points include: Regulatory applications: clarification on when Real World Data (RWD) studies may support regulatory submissions. Artificial Intelligence (AI): if AI …
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