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concept paper

concept paper [ENGLISH]

A document prepared by a European Medicines Agency working party prior to the drafting of a guideline, setting out the problem, the scope of the work, the resources needed and the timeframe. 

concept paper [SWEDISH]

Ett dokument som utarbetats av en arbetsgrupp inom den europeiska läkemedelsmyndigheten som föregår utarbetandet av en riktlinje. Ett 'concept paper' beskriver problemet, omfattningen av arbetet, de resurser som behövs och tidsramen.


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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