Pharmacovigilance Risk Assessment Committee (PRAC)
GPTKB entity
Statements (59)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Committee
|
| gptkbp:aimsTo |
Patient safety
|
| gptkbp:analyzes |
Adverse drug reactions
Safety signals Data from clinical studies Adverse event reporting Data from EHRs Post-marketing data |
| gptkbp:collaboratesWith |
International organizations
National competent authorities Healthcare_professionals |
| gptkbp:communityFeedback |
Risk management plans
|
| gptkbp:composedOf |
Experts in pharmacovigilance
|
| gptkbp:conducts |
Public consultations
Pharmacovigilance practices Public perception of drug safety |
| gptkbp:conductsResearchOn |
Pharmacovigilance methodologies
|
| gptkbp:coordinatesWith |
Other_EU_committees
|
| gptkbp:develops |
Guidelines for risk assessment
Frameworks for risk assessment. |
| gptkbp:developsStrategiesFor |
Risk management
|
| gptkbp:established |
European_Union_legislation
|
| gptkbp:evaluates |
Emerging safety issues
Benefit-risk balance of medicines |
| gptkbp:facilitates |
Risk communication
|
| gptkbp:focusesOn |
Drug safety
|
| https://www.w3.org/2000/01/rdf-schema#label |
Pharmacovigilance Risk Assessment Committee (PRAC)
|
| gptkbp:influences |
Regulatory decisions
|
| gptkbp:isRecognizedFor |
Post-marketing surveillance
Risk communication strategies Risk minimization measures Drug labeling changes Safety monitoring practices |
| gptkbp:issueFeePaid |
Safety evaluations
Public health concerns |
| gptkbp:issues |
Safety recommendations
|
| gptkbp:meets |
Monthly
|
| gptkbp:monitors |
Pharmacovigilance systems
|
| gptkbp:participatesIn |
Safety monitoring activities
Scientific advice procedures |
| gptkbp:partOf |
gptkb:European_Medicines_Agency
|
| gptkbp:providesGuidanceOn |
Risk assessment methodologies
|
| gptkbp:providesGuidelinesFor |
Pharmacovigilance practices
Risk evaluation and mitigation strategies |
| gptkbp:providesInformationOn |
Regulatory guidelines
|
| gptkbp:providesServices |
gptkb:European_Commission
|
| gptkbp:providesSupportFor |
Regulatory frameworks
Risk assessment processes |
| gptkbp:providesTrainingFor |
Safety reporting
|
| gptkbp:publishes |
Safety assessments
|
| gptkbp:responsibleFor |
Assessing risks of medicines
|
| gptkbp:reviews |
Safety data
Risk assessment methodologies Risk assessment reports Clinical trial safety data Periodic safety update reports |
| gptkbp:supports |
Regulatory compliance
|
| gptkbp:worksOn |
Signal detection
|
| gptkbp:worksWith |
Stakeholders in healthcare
|