PDCO

E130567

PDCO is the European Medicines Agency’s Paediatric Committee, responsible for assessing and promoting the development and safe use of medicines for children in the European Union.

All labels observed (1)

Label Occurrences
PDCO canonical 3

How this entity was disambiguated

Statements (46)

Predicate Object
instanceOf European Union body ⓘ
Paediatric Committee of the European Medicines Agency ⓘ
regulatory committee ⓘ
acronym PDCO ⓘ
associatedWithPolicy EU paediatric medicines regulation ⓘ
composition members nominated by EEA-EFTA states ⓘ
members nominated by EU Member States ⓘ
members representing healthcare professionals ⓘ
members representing patient organisations ⓘ
country European Union ⓘ
ensuresComplianceWith requirements for paediatric data in marketing authorisation applications ⓘ
field paediatric medicines regulation ⓘ
pharmacovigilance for paediatric use ⓘ
public health ⓘ
formedAs scientific committee within EMA ⓘ
fullName Paediatric Committee ⓘ
goal avoid unnecessary paediatric clinical trials ⓘ
ensure medicines for children are subject to high-quality research ⓘ
improve health of children in the European Union ⓘ
headquartersLocation Amsterdam, Netherlands ⓘ
linked to: Amsterdam
jurisdiction European Union ⓘ
languageOfWork English ⓘ
legalBasis Regulation (EC) No 1901/2006 on medicinal products for paediatric use ⓘ
Regulation (EC) No 1902/2006 amending Regulation (EC) No 1901/2006 ⓘ
locatedIn EMA headquarters ⓘ
parentOrganization European Medicines Agency ⓘ
responsibility advising on quality, safety and efficacy of paediatric medicines ⓘ
assessing deferrals for paediatric studies ⓘ
assessing paediatric investigation plans ⓘ
assessing waivers for paediatric studies ⓘ
contributing to EU paediatric medicines strategy ⓘ
promoting development of medicines for children ⓘ
promoting safe use of medicines for children ⓘ
providing opinions on paediatric investigation plans ⓘ
supporting availability of age-appropriate formulations ⓘ
scopeOfWork medicinal products for human use ⓘ
supervisesProcess evaluation of paediatric investigation plans for medicines seeking EU marketing authorisation ⓘ
targetPopulation adolescents ⓘ
children ⓘ
topic paediatric clinical trials ⓘ
paediatric investigation plan ⓘ
paediatric use marketing authorisation ⓘ
typeOfBody scientific advisory committee ⓘ
website https://www.ema.europa.eu/en/committees/paediatric-committee-pdco ⓘ
worksWith Committee for Medicinal Products for Human Use ⓘ
Pharmacovigilance Risk Assessment Committee ⓘ

How these facts were elicited

Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.