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EMEA: Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population

28.02.2009
EMEA:
Reflection paper on the extrapolation of results from clinical studies conducted outside europe to the eu-population. This reflection paper, reflecting experience from recent applications, demonstrates that in particular extrinsic factors, such as medical practice, disease definition and study population, may influence the applicability of foreign data to an EU setting.