Paediatric Pharmacovigilance of biologicals - a myth or a challenge - - PowerPoint PPT Presentation

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paediatric pharmacovigilance of biologicals a myth or a
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Paediatric Pharmacovigilance of biologicals - a myth or a challenge - - PowerPoint PPT Presentation

Feb 15, 2023 796 likes •882 views

Paediatric Pharmacovigilance of biologicals - a myth or a challenge - Paediatric pharmacovigilance of biological Challenge of Pharmacovigilance Planning Multifactorial Pharmacovigilance small numbers to be treated Indication and

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SLIDE 1

Paediatric Pharmacovigilance of biologicals

  • a myth or a challenge -
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SLIDE 2

Challenge of Pharmacovigilance Planning

  • Multifactorial Pharmacovigilance
  • small numbers to be treated
  • Indication and dosage
  • appropriate formulation
  • Organ impairment

EMA, 2010, Dirk Mentzer

Paediatric pharmacovigilance of biological

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SLIDE 3

clinical studies PMSS, Pharmaco-epidemiological studies Spontaneous reports, Registries Pharmacovigilance aspects

EMA, 2010, Dirk Mentzer

Paediatric pharmacovigilance of biological

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SLIDE 4

clinical studies PMSS, Pharmaco-epidemiological studies Spontaneous reports, Registries Pharmacovigilance aspects

EMA, 2010, Dirk Mentzer

Paediatric pharmacovigilance of biological Nice to have Favorable and Feasible Possible and real life

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SLIDE 5

Wish list for PhV in paediatrics

  • Case definitions for adverse reactions in children
  • Elaborating surrogate parameters and indicator Symptoms for

ADRs to be specified in the EU-RMP

  • Feasibility and responsibility for long-term follow up including

registries and linked databases for aggregation of knowledge

  • More interdisciplinary network of learned societies and regulators

involving paediatric pharmacovigilance centres

EMA, 2010, Dirk Mentzer

Paediatric pharmacovigilance of biological

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SLIDE 6

Wish list for PhV in paediatrics

  • Case definitions for adverse reactions in children

data collection, analysis, presentation and assessment

  • Elaborating surrogate parameters and indicator Symptoms for

ADRs to be specified in the EU-RMP Pathomechanism (in vitro studies, juvenile animal toxicology studies) and adult experience

  • Feasibility and responsibility for long-term follow up including

registries and linked databases for aggregation of knowledge Post-marketing Phase IV studies as a part of the PIP – How long?

  • More interdisciplinary network of learned societies and regulators

involving paediatric pharmacovigilance centres Education and awareness of collaboration of societies

EMA, 2010, Dirk Mentzer

Paediatric pharmacovigilance of biological

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SLIDE 7

Paediatric Pharmacovigilance clearing up