Paediatric Committee
E23507
The Paediatric Committee is a scientific body within the European Medicines Agency responsible for assessing and promoting the development and safe use of medicines for children in the European Union.
Observed surface forms (1)
| Surface form | As subject | As object |
|---|---|---|
| Pediatric Committee | 0 | 1 |
Statements (44)
| Predicate | Object |
|---|---|
| instanceOf |
body of the European Medicines Agency
→
regulatory advisory committee → scientific committee → |
| aim |
to ensure that medicines for children are appropriately authorised
→
to ensure that medicines for children are appropriately labelled → to ensure that medicines used to treat children are subject to high-quality research → to improve the health of children in the European Union → |
| country | European Union → |
| field |
paediatric medicine
→
pharmacology → public health → regulatory science → |
| goal |
to avoid delaying the authorisation of medicines for adults
→
to balance the needs of paediatric and adult populations in medicine development → to reduce unnecessary clinical trials in children → |
| hasAbbreviation | PDCO → |
| hasOutput |
contributions to EMA guidelines on paediatric use of medicines
→
guidance on paediatric medicine development → opinions on paediatric investigation plans → recommendations on waivers and deferrals → |
| hasScope |
medicines for paediatric populations
→
off-label use of medicines in children → paediatric clinical trials → paediatric investigation plans → |
| jurisdiction | European Union → |
| legalBasis |
Paediatric Regulation
→
Regulation (EC) No 1901/2006 → |
| locatedIn |
Amsterdam
→
Netherlands → |
| parentOrganization | European Medicines Agency → |
| partOf | European Medicines Agency → |
| responsibleFor |
advising on quality, safety and efficacy of paediatric medicines
→
assessing applications for paediatric investigation plan deferrals → assessing applications for paediatric investigation plan waivers → assessing the development of medicines for children → promoting the development of medicines for children → promoting the safe use of medicines for children → providing scientific opinions on paediatric investigation plans → supporting the availability of authorised medicines for children → |
| worksWith |
Committee for Medicinal Products for Human Use
→
Pharmacovigilance Risk Assessment Committee → healthcare professionals → national competent authorities of EU Member States → patient and parent organisations → |
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
subject surface form:
European Medicines Agency
this entity surface form:
Pediatric Committee