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Table. 2.

Table. 2. Example of Presenting User Testing Results in EMA
Presentation of Results (Guideline)
1.3.4. Consultation with target patient groups
1. Product Description
2. Consultation or test details, such as:
· Method used
· Explanation on the choice of population consulted
· Language(s) tested
3. Questionnaire
(including instructions and observation forms)
4. Original and revised package leaflets
5. Summary and discussion of results
(subjects’ answers, problems identified and revisions made to relevant package leaflet section)
6. Conclusion

Source: European Commission (2009) Guideline on the readability of the labelling and package leaflets of medicinal products for human use (Revision 1)

Yakhak Hoeji 2023;67:404-14 https://doi.org/10.17480/psk.2023.67.6.404
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