Publications & Reference Documents

Platform Publications:

Press Releases:

Relevant Publications:

Relevant Regulations:

  • EU Regulation on medicinal products for paediatric use [EU Regulation on medicinal products for paediatric use [Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004e]

Relevant Links:

Abbreviations:

  • ALK: anaplastic lymphoma kinase
  • BPCA: Biologics Price Competition & Innovation
  • CDDF: Cancer Drug Development Forum
  • EMA: European Medicines Agency
  • ENCCA: European Network for Cancer Research in Children and Adolescents
  • FDA: Food and Drug Agency
  • IMI: Innovative Medicine Initiative
  • ITCC: Innovative Therapies for Children with Cancer
  • LTFU: long-term follow-up
  • MA: marketing authorisation
  • MoA: Mechanism of Action
  • PDCO: Paediatric Committee [of the EMA]
  • PIP: Paediatric Investigation Plan
  • PK: pharmacokinetic
  • PPoC: paediatric proof of concept
  • PREA: Pediatric Research Equity Act
  • PRINTO: Paediatric Rheumatology International Trials Organisation
  • SIOPE: European Society for Paediatric Oncology
  • US[A]: United States [of America]
  • TYA: teenagers and young adults
  • WG: Working Group
  • WR: written requests

 



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