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539 articles and field notes
Instructions for use must reach the user in a language the member state accepts. What that means in practice, and why IFUs fail on usability, not wording.
Samhitha J Bhatt · Aug 17, 2026
Consent is only valid if the participant understood. What that requires of a translated ICF, and why site-level and ethics-committee review cannot be skipped.
Samhitha J Bhatt · Aug 17, 2026
A detail aid is a claims document in a designed layout. What has to be re-approved per market, and why a translated aid is not the same asset as the source.
Samhitha J Bhatt · Aug 17, 2026
Carton and label artwork is where approved text meets a fixed physical space. Why expansion is the recurring failure, and what a proofing cycle has to catch.
Samhitha J Bhatt · Aug 17, 2026
A package leaflet has to be understood by a worried person, not just be accurate. What readability testing changes, and why literal translation often fails it.
Samhitha J Bhatt · Aug 17, 2026
Compliance training produces evidence, not just understanding. What a translated module has to prove, and how to stop an update orphaning a language.
Samhitha J Bhatt · Aug 17, 2026
