Institution identification

PURI

https://redirect.ema.europa.eu/resource/2412

Institution ID

2412

Institution full name and acronym

Department of Pharmacology, University of Bologna (UNIBO)

Institution countries

Italy

Type of institution

Educational Institution

Institution website

ENCePP partner

Yes
Institution description
Safety evaluation and regulatory aspects of drugs with QT liability: (1) critical review of the published literature to rank drugs of specific classes,(2) drug utilisation studies to indirectly quantify population exposure to drugs with QT liability,(3) signal detection of Torsades de Pointes gathered through investigation of spontaneous reporting databases (FP7 project: ARITMO). Safety issues currently under investigation by analysing international spontaneous reporting databases: drug-induced TdP,drug-induced PML and glitazones,collaborative projects with the Italian Medicines Agency (i.e.,antipsychotics,hepatotoxicity,biphosphonates). Drug utilisation: active involvement in EuroDURG and SIG-DUR-ISPE initiatives (e.g. CNC project and European ATC browser),study of patterns of drug use and appropriateness in Italy (i.e.,cardiovascular drugs,osteoporosis,antipsychotics,multiple sclerosis,NSAIDs) by using drug prescription databases,questionnaires,registries.
Institution details
Experience with collecting data directly from individual patients or respondents:
Yes
Interest in carrying out research that is funded by pharmaceutical companies:
No

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