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deferral (paediatric) [ENGLISH]

The possibility to defer a measure in a paediatric investigation plan until after studies in adults have been conducted. This ensures that research in children is done only when it is safe and ethical to do so. Deferrals are adopted by the Paediatric Committee (PDCO). 

uppskov [SWEDISH]

Pediatriska kommitten vid den europeiska läkemedelsmyndigheten (PDCO) kan vid behov besluta om uppskov (deferral) av genomförande av alla/vissa studier i en pediatrisk rövningsplan (PIP), det vill säga studierna på barn kan senareläggas tills man fått erfarenhet från användning hos vuxna patienter.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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