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risk management system [ENGLISH]

A set of activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines, including the assessment of the effectiveness of those activities and interventions.

riskhanteringssystem [SWEDISH]

En uppsättning aktiviteter och insatser utformade för att identifiera, karakterisera, förebygga eller minimera risker relaterade till läkemedel, inklusive bedömning av effektiviteten av dessa aktiviteter och insatser.


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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