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kvalificerad person (QP)

qualified person [ENGLISH]

Individual with legal responsibility for certifying that a batch of medicinal product or material meets the set requirements prior to use in a clinical trial or release onto the market.

kvalificerad person [SWEDISH]

När personen har den fackkunskap som krävs för att genomföra kontroller av arbetsutrustning och anläggningar som kräver övervakning.


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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