Plasma master file epidemiology
EventCorporate
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Fecha
- Martes, 18 Noviembre 2014, Todo el día
Ubicación
- 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.