Viola Macolić Šarinić
World Health Organization
Competence (human resources)Baseline (configuration management)CYP3A4Coding (therapy)Internal medicineAgency (sociology)ReductasePublic healthCase-control studyRetrospective cohort studyPharmacogenomicsWork (electrical)Intensive care medicineBest practicePediatricsProspective cohort studyProcess managementMedical physicsQuality management systemNear missDeliverableStatinPreparednessRotavirus vaccineLegislationAtorvastatinMarketing authorizationMalariaFluvastatinMEDLINEPharmaceutical industryQuality of life (healthcare)DrugAdverse drug reactionConcomitant TherapyIntersectoral CollaborationABCG2 GeneEuropean unionDevice ApprovalDrug classificationHydroxymethylglutaryl-CoA Reductase InhibitorsAge groupsReference standardsRegulatory authorityDrug approvalRenal transplantDrug reactionIn patientPaediatric populationRetrospective reviewPaediatric ageRisk managementPolypharmacyIncidence (epidemiology)Economic growthMedical educationAbcg2Medical emergencyPharmacovigilanceGenetic predispositionMedicineCroatianPharmacology
19Publications
5H-index
114Citations
Publications 16
Newest
#1Noha Iessa (WHO: World Health Organization)
#2Viola Macolić Šarinić (WHO: World Health Organization)H-Index: 5
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The Smart Safety Surveillance (3S) concept is based on the understanding that, when faced with competing pharmacovigilance priorities, countries will have to invest judiciously, by focusing on new priority products, sharing work and resources with other countries when possible and building national competence for those activities that cannot be delegated. The 3S principles were applied to Armenia, Brazil, Ethiopia, India, Peru and Thailand using three priority products: bedaquiline, rotavirus va...
Source
#1Nada BožinaH-Index: 9
#2Nikica MiroševićH-Index: 2
Last. Viola Macolić ŠarinićH-Index: 5
view all 8 authors...
#1Anna Radecka (Medicines and Healthcare Products Regulatory Agency)H-Index: 2
#2Louise Loughlin (Medicines and Healthcare Products Regulatory Agency)H-Index: 1
Last. June Raine (Medicines and Healthcare Products Regulatory Agency)H-Index: 15
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In November 2013, a team of European regulators initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Funded by the Health Programme of the European Union, and with contributions from the involved Member States, SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems to meet the requirements of the pharmacovigilance legislation that came into effect in June 2012. The SCOPE project...
7 CitationsSource
#1Nada BožinaH-Index: 9
#2Lana GanociH-Index: 6
Last. Viola Macolić ŠarinićH-Index: 5
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#1Carla Carnovale (University of Milan)H-Index: 18
#2Marta Gentili (University of Milan)H-Index: 9
Last. Sonia Radice (University of Milan)H-Index: 21
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ABSTRACTObjective: to characterise the adverse drugs reactions (ADRs) reported in the Lombard and Croatian paediatric population and to compare data to specific paediatric age groups, in terms of trend, pattern and severity of ADRs, increasing understanding of paediatric ADRs.Research design and methods: We selected and analysed all the spontaneous reports in which children were involved (0 < 18 years old) reported in the Lombardy and in Croatian pharmacovigilance databases from 1th March 2005 t...
1 CitationsSource
#1Linda HärmarkH-Index: 14
#2June Raine (Medicines and Healthcare Products Regulatory Agency)H-Index: 15
Last. Agnes KantH-Index: 2
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The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt...
28 CitationsSource
#1Nada BožinaH-Index: 9
Last. Viola Macolić ŠarinićH-Index: 5
view all 6 authors...
#2Lana GanociH-Index: 6
Last. Nada BožinaH-Index: 9
view all 7 authors...
#1Nada BožinaH-Index: 9
Last. Viola Macolić ŠarinićH-Index: 5
view all 3 authors...