PromoSolution conducts readability testing of patient information leaflets (PILs) in accordance with the EAEU requirements (EEC Decision № 88).
PRT is carried out in Russian on the territory of the Republic of Belarus according to the standard methodology proposed for use by the Eurasian Economic Commission.
PRT carried out by PromoSolution includes:
- PIL GAP analysis for readability
- Testing plan and materials preparation
- One-on-one interviews with 20 volunteers from the medicinal products target group
- Analysis of the received data
- Preparation of a report for submission within the CTD module 1.3.4