According to Directive 2001/83/EC as amended by Directive 2004/27/EC, the readability of the labelling and package leaflet of medicinal products for human use became mandatory across the European Union, requiring that consultation with target patient groups (‘user consultation’) be carried out to demonstrate the readability and usefulness of the labelling and package leaflet to patients.
SEQ offers testing on all forms of patient information for all product types, including devices, and dosage forms.
SEQ have established quality standards throughout the process, developing accepted standardised methods for generating, recording and reporting.
SEQ offer a service that meets your needs from:
Writing protocol and questionnaire development.
Critical Assessment and review of existing leaflets.
Writing and designing a leaflets.
Creating a leaflet template for a product portfolios.
Recruitment of test participants.
Arranging and undertaking one to one interviews.
Writing the final “submission ready” reports.
Bridging reports – Abridged and full (focus testing) reports
Successful Readability User Testing reports have been generated for all product presentations in respect of National, CP, MRP and DCP submissions throughout the EU.
For companies with large portfolios, SEQ will develop testing and bridging strategies aimed at reducing time and costs.