Statements (62)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulation
|
| gptkbp:addresses |
specific needs of children
|
| gptkbp:aimsTo |
improve pediatric drug development
off-label use in children |
| gptkbp:appliesTo |
medicinal products
|
| gptkbp:encourages |
collaboration between stakeholders
|
| gptkbp:encouragesParticipationIn |
parents and children
|
| gptkbp:enforces |
gptkb:European_Medicines_Agency
obligations on sponsors |
| gptkbp:establishedIn |
2007
|
| gptkbp:hasCollaboratedWith |
academic institutions
pharmaceutical companies |
| https://www.w3.org/2000/01/rdf-schema#label |
EU pediatric regulation
|
| gptkbp:includes |
incentives for pharmaceutical companies
|
| gptkbp:includesProvisionsFor |
clinical trials in children
|
| gptkbp:isAssignedTo |
WHO recommendations
|
| gptkbp:isAvailableIn |
gptkb:European_Union
|
| gptkbp:isChallengedBy |
some stakeholders
|
| gptkbp:isCriticizedFor |
complexity of requirements
|
| gptkbp:isDiscussedIn |
medical journals
international conferences policy forums EU_legislative_bodies |
| gptkbp:isEvaluatedBy |
regulatory compliance
cost-effectiveness independent researchers impact on drug availability impact on pediatric health |
| gptkbp:isExaminedBy |
academic literature
|
| gptkbp:isInfluencedBy |
public health research
scientific_advice_from_EMA |
| gptkbp:isInformedBy |
pediatric_clinical_data
|
| gptkbp:isIntegratedWith |
ensure safety and efficacy of drugs for children
healthcare_systems |
| gptkbp:isLinkedTo |
patient safety initiatives
pediatric ethics pediatric health outcomes pediatric drug safety. orphan_drug_regulation |
| gptkbp:isLocatedIn |
national regulations
|
| gptkbp:isMonitoredBy |
gptkb:European_Medicines_Agency
|
| gptkbp:isPartOf |
global health initiatives
EU_health_policy EU_pharmaceutical_legislation |
| gptkbp:isPromotedBy |
healthcare_professionals
|
| gptkbp:isPromotedThrough |
educational initiatives
public awareness campaigns |
| gptkbp:isRelatedTo |
pediatric pharmacology
|
| gptkbp:isReviewedBy |
gptkb:European_Commission
to assess effectiveness |
| gptkbp:isSubjectTo |
legal challenges
public scrutiny |
| gptkbp:isSupportedBy |
government policies
clinical guidelines advocacy groups research funding initiatives clinical trials data |
| gptkbp:isUpdatedBy |
regulatory reviews
|
| gptkbp:promotes |
research in pediatric populations
|
| gptkbp:provides |
guidelines for clinical trials
|
| gptkbp:requires |
pediatric investigation plans
|
| gptkbp:supports |
development of age-appropriate formulations
|