Plasma master file epidemiology

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Datum

utorak, 18 studenog 2014, Cijeli dan

Lokacija

European Medicines Agency, Amsterdam, the Netherlands

The purpose of this workshop is to look at data submission and evaluation and discuss the following topics: approaches to monitor trends and to establish acceptable ranges for epidemiological data, residual risk calculation, HBsAg adjustment factor and window periods used in calculations; extension of the trend analysis period to more than 3 years now that data is available over longer periods in the format required by the guideline;the usefulness of both graphical representations of trends and statistical significance approaches for trend analysis for organisations and countries; approaches to identify trends on a centre basis; criteria for acceptance of new centres in terms of epidemiological data.Registration by invitation only. Places limited. Registration open until 18/10/2014.

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