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 2

How this entity was disambiguated

Statements (46)

Predicate Object
instanceOf European Union body
Paediatric Committee of the European Medicines Agency
regulatory committee
acronym PDCO self-link
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
surface form: Amsterdam, Netherlands
jurisdiction European Union
languageOfWork English
legalBasis Paediatric Regulation
surface form: 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 (2)

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

PDCO acronym PDCO self-link