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Sample Glossary Extract

Sample Glossary Extract (abbreviated sample)

This short sample shows the format and structure of a Sesen life sciences glossary. Full glossaries include expanded term sets, additional languages, and references to relevant regulatory modules.

Term

Definition

French

German

Module Reference

Active substance

Biologically active ingredient in a pharmaceutical product

Substance active

Wirkstoff

Regulatory Dossier

Blinded study

Clinical trial design where participants and/or investigators are unaware of treatment allocation

Étude en aveugle

Verblindete Studie

Clinical Protocol

Contraindication

Condition or factor that serves as a reason to withhold a certain treatment

Contre-indication

Kontraindikation

Product Labeling

Dose escalation

Gradual increase of drug dosage to assess tolerance and safety

Augmentation de dose

Dosiseskalation

Investigator Brochure

Post-market surveillance

Monitoring of a medical device after release to market

Surveillance post-commercialisation

Marktüberwachung

Vigilance Reporting

Quality control (QC)

Procedures to ensure a product meets defined quality criteria

Contrôle qualité

Qualitätskontrolle

Manufacturing SOP

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