WHO Programme for International Drug Monitoring UMC perspective on Kazakhstan and other...
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WHO Programme for International Drug Monitoring UMC perspective on Kazakhstan and other member-countries in the region Nadja Jastrebova Pharmacovigilance
WHO Programme for International Drug Monitoring UMC perspective
on Kazakhstan and other member-countries in the region Nadja
Jastrebova Pharmacovigilance Consulting Global Services
Section
Slide 2
Nadja Jastrebova, Uppsala Monitoring Centre Thalidomide -
phocomelia
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WHO Drug Monitoring Programme Founding Members (1968)
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Nadja Jastrebova, Uppsala Monitoring Centre PV today Adverse
reactions Inadequate/incorrect useProduct quality problemsOther
safety challenges
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Official and associate member countries (2014)
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Nadja Jastrebova, Uppsala Monitoring Centre Population
coverage
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Nadja Jastrebova, Uppsala Monitoring Centre Member obligations
Send high quality ICSRs frequently Actively participate in the WHO
Programme Being a member of the WHO Medicines Safety Programme
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Nadja Jastrebova, Uppsala Monitoring Centre WHO International
PV Programme WHO-CC Netherlands Lareb WHO-CC Netherlands Lareb
WHO-HQ Geneva WHO-HQ Geneva WHO-CC Sweden UMC WHO-CC Sweden UMC
National Centres WHO-CC Ghana UMC-A WHO-CC Ghana UMC-A Healthcare
Pharma industry Pharma industry WHO-CC Morocco CAPM WHO-CC Morocco
CAPM Patient safety data Patients (directly) Patients
(directly)
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Nadja Jastrebova, Uppsala Monitoring Centre UMC - WHO
Collaborating Centre for International Drug Monitoring the Uppsala
Monitoring CentreEstablished as a foundation 1978Agreement between
Sweden and WHOWHO-HQ responsible for policy issuesInternational
administrative boardSelf financing
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Nadja Jastrebova, Uppsala Monitoring Centre UMCs vision and
main tasks Improve worldwide patient safety and welfare by reducing
the risk of medicines Collect and analyse individual case safety
reports (ICSRs) worldwide Communicate potential patient safety
issues Actively support and provide training in Pharmacovigilance
Develop the science of Pharmacovigilance
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Nadja Jastrebova, Uppsala Monitoring Centre VigiBase WHO global
ICSR database The oldest and largest global ICSR database Used for
global and country specific signal detection Free to search in by
National Centres of member countries Customized searches are
performed on request from companies and other interested
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Nadja Jastrebova, Uppsala Monitoring Centre VigiBase and report
accumulation Americas Europe Asia Oceania Africa Total
Nadja Jastrebova, Uppsala Monitoring Centre Quality of ICSRs
vigiGrade - Completeness Score Way of measuring the amount of
information on ICSRs Calculated from 8 parameters important for
analysis: Type of reportPrimary sourceGenderAge at onsetTime to
onsetIndicationOutcomeFree text
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Nadja Jastrebova, Uppsala Monitoring Centre Countries % Quality
of ICSRs vigiGrade - Completeness Score
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Nadja Jastrebova, Uppsala Monitoring Centre Reporting format
Country ACountry C Country B hari yang baik UMC
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Nadja Jastrebova, Uppsala Monitoring Centre Reporting format
and harmonization E2B Country A E2B Country B Country C E2B
UMC
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Nadja Jastrebova, Uppsala Monitoring Centre Signal detection
Periodic screening of VigiBase dataManual review of literature and
ICSRsClinical assessment by international expert
panelPublication/communication to National Centres UMC is not a
regulatory body
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Nadja Jastrebova, Uppsala Monitoring Centre
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http://www.who-umc.org
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Nadja Jastrebova, Uppsala Monitoring Centre Training 43 Web
lectures from UMC PV Courses
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Nadja Jastrebova, Uppsala Monitoring Centre Publications
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Nadja Jastrebova, Uppsala Monitoring Centre Thank you for your
attention! [email protected]
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Nadja Jastrebova, Uppsala Monitoring Centre Quality vs.
quantity
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Nadja Jastrebova, Uppsala Monitoring Centre Quality vs.
quantity 4 + Enter to see non-European countries