Readability Testing of PILs
Enhancing Patient Safety through PIL Readability Testing
Our streamlined process ensures Patient Information Leaflets (PILs) comply with EMA standards and the European Commission’s Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use (12.1.2009), focusing on readability and regulatory adherence.
We refine PILs for clarity, following the EMA’s QRD template with a patient-centric approach. We enhance PIL understandability through targeted evaluations and feedback from pilot tests with at least 20 participants. This iterative method boosts patient engagement, safety, and informed decision-making, ensuring full compliance with regulations.
Our services include:
- Streamlined readability study planning and execution to meet regulatory timelines.
- Guidance on optimizing leaflets and layouts per EU regulations.
- Coordination of study management with external experts or testing facilities.
Benefits of NN Translations for Healthcare Stakeholders:
- Clear PILs: Compliant and understandable.
- Regulatory Compliance: Fulfilling pharmaceutical and healthcare standards.
- Patient Trust: Enhancing trust, adherence, and outcomes.
