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Uppsala Monitoring Centre
34,00 € *
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High Quality Content by WIKIPEDIA articles! The Uppsala Monitoring Centre (the UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. The UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance programs in regards to the benefits, harm, effectiveness and risks of drugs. Since 1978, responsibility for managing the WHO Programme for International Drug Monitoring has been carried by the UMC. In the early years the staff consisted of just three pharmacists based at the Swedish Medical Products Agency (Läkemedelsverket), currently over 60 staff work in central Uppsala.

Anbieter: Dodax
Stand: 19.01.2020
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Development of a Standard Report for Signal Ver...
30,80 € *
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Publically available external pharmacovigilance databases, such as the American FDA’s Adverse Event Reporting System (AERS) and the VigiBase database of the Uppsala Monitoring Centre (UMC), are currently not obligatorily taken into account by the pharmaceutical product manufacturers regarding potential drug safety signals. The value of this information on adverse events that is revealed in these databases is well acknowledged by product experts. These external data sources are now being evaluated for their suitability to at least support signal verification for signals which have been detected within a pharmaceutical company. The appropriate software tools needed to support the integration of this information into the commonly used statistical methods of signal detection have been developed. In his study, Denny Lorenz evaluates the benefit of the reports that the market leading software ‘Empirica Signal’ generates for common questions during the signal verification process. The major external databases and statistical methods are described and structurally assessed. Besides the selection of reports, contrary opinions on the hierarchy levels of drug and event on which the statistical scores are calculated, are discussed. The study demonstrates that the decision on these levels and the depths of the external analyses itself is a trade-off between scientific ambitions and the limits of time and money that companies are willing to invest in this endeavor.

Anbieter: Dodax AT
Stand: 19.01.2020
Zum Angebot
Development of a Standard Report for Signal Ver...
29,90 € *
ggf. zzgl. Versand

Publically available external pharmacovigilance databases, such as the American FDA’s Adverse Event Reporting System (AERS) and the VigiBase database of the Uppsala Monitoring Centre (UMC), are currently not obligatorily taken into account by the pharmaceutical product manufacturers regarding potential drug safety signals. The value of this information on adverse events that is revealed in these databases is well acknowledged by product experts. These external data sources are now being evaluated for their suitability to at least support signal verification for signals which have been detected within a pharmaceutical company. The appropriate software tools needed to support the integration of this information into the commonly used statistical methods of signal detection have been developed. In his study, Denny Lorenz evaluates the benefit of the reports that the market leading software ‘Empirica Signal’ generates for common questions during the signal verification process. The major external databases and statistical methods are described and structurally assessed. Besides the selection of reports, contrary opinions on the hierarchy levels of drug and event on which the statistical scores are calculated, are discussed. The study demonstrates that the decision on these levels and the depths of the external analyses itself is a trade-off between scientific ambitions and the limits of time and money that companies are willing to invest in this endeavor.

Anbieter: Dodax
Stand: 19.01.2020
Zum Angebot