EMEA: Reflection paper in the Extrapolation of results from clinical studies conducted outside europe to the eu-population
19.11.2009
This reflection paper, including experience from a sample of applications, shows 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.
Źródło wiadomośći: http://www.emea.europa.eu/pdfs/human/ewp/69270208enfin.pdf
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