User testing of the package leaflet

User testing allows you to evaluate how effectively the package leaflet works in practice, identify barriers that reduce understanding and use of the information provided, and identify problem areas that require improvement.

The process of user testing of the package leaflet includes the following stages:

1. Developing a testing protocol.
2. Preliminary expert assessment of the package leaflet.
3. Selecting and training an interviewer.
4. Recruiting a target group of test participants.
5. Conducting pilot testing.
6. Analyzing the results of the pilot testing and making changes to the protocol or package leaflet.
7. Conducting the main testing phase.
8. Processing the results of user testing.

Preparing a report on the results of user testing includes:

• Brief description of the dosage form.
• Summary of the testing conducted.
• Questionnaires and questionnaires used.
• The original and revised version of the instructions for medical use (IMP).
• A brief description and discussion of the testing results.
• Conclusion.

Each of these stages includes important aspects and requirements of regulatory authorities. The user testing report must be attached to the registration dossier for review.