ATMP - kommitten för avancerade terapier (CAT)

kommitten för avancerade terapier (CAT) (CAT)

Committee for Advanced Therapies [ENGLISH]

The committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines, including medicines classified as gene therapy, somatic-cell therapy or tissue-engineered products.

kommitten för avancerade terapier (CAT) [SWEDISH]

Kommittén för avancerade terapier: den kommitté inom European Medicines Agency som ansvarar för att bedöma kvaliteten, säkerheten och effektiviteten av läkemedel för avancerad terapi, inklusive läkemedel som klassificeras som genterapi, somatisk cellterapi eller vävnadstekniska produkter.

2024-01-29

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Resources and references

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

1. American Society of Gene and Cell Therapy Glossary https://www.asgct.org/education/more-resources/glossary
2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
9. Toolkit For Patient Focused Therapy Development Glossary https://toolkit.ncats.nih.gov/glossary-2/

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