Services/MA Studies
MA STUDIES · READABILITY & USABILITY
I carry out readability and usability studies for MA files, to assess how well information is understood and how the medicine, its packaging or its administration device is handled.
Each study is designed in line with Directive 2001/83/EC, the recommendations of the European Medicines Agency, and ANSM expectations.
The goal: precisely identify what is understood, what causes difficulty, and the adjustments needed before filing or updating the file.
Readability and usability studies compliant with EMA / ANSM expectations.
WHO IT'S FOR
A package leaflet readability study, or documentation of a study compliant with EMA / ANSM expectations.
Understanding of information intended for patients or users, before filing or updating.
Packaging, administration device, associated materials, or adapting an existing study.
The study helps objectively identify comprehension or handling difficulties and document the improvements proposed.
WHAT I BRING
Readability and usability studies assess whether users correctly understand the essential information and manage to handle the medicine or its packaging under representative conditions.
I support the preparation, conduct and analysis of these studies: protocol, interview guide, running the user tests, analysis of difficulties encountered, and writing the report.
The approach aims for usable results: what is understood, what isn't, and what can be improved.
What can be included
SCOPE
Understanding of information, package leaflet, essential wording.
Handling of the packaging or the administration device.
Identifying difficulties and recommending adjustments.
Studies designed in line with Directive 2001/83/EC and EMA / ANSM recommendations.
METHOD
01
Define the study's objective, the profiles, the materials to be assessed and the recruitment criteria.
02
Conduct interviews and role-play scenarios under conditions suited to the product and the users involved.
03
Analyse the difficulties, document the results and formalise the recommendations in the study report.
Let's discuss your medicine, your materials and the applicable requirements.
Talk about your MA study