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pediatrisk prövningsplan (PIP)

Paediatric Investigation Plan [ENGLISH]

Document upon which the development and authorisation of medicinal products for the paediatric population is based. It is presented by an applicant early during the development of a product to the EMA Paediatric Committee in order to agree a paediatric development plan.

pediatrisk prövningsplan [SWEDISH]

Dokument som ligger till grund för utveckling och godkännande av läkemedel för den pediatriska populationen. Den presenteras av en sökande tidigt under utvecklingen av en produkt till EMA Pediatric Committee för att komma överens om en pediatrisk utvecklingsplan.


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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