Summaries of product characteristics (SPC), product information leaflets (PIL) and labelling:
- Preparation, translation and updating of texts
- Packages printing process and package leaflets steering
- Managing pan-CIS labelling projects
Readability testing of product information leaflets (PIL):
- Readability tests of package leaflets in accordance with EU directives, especially to the findability, applicability and understandability of text
- The entire testing from the preparation of the package leaflet up to the Final Report is handled. The issued signed Final Report will confirm that testing both, one by one and altogether has succeeded
- Interviews, performed by professionals
- Individually structured test designs; user tested interviews with independent observers and supervisor
- All events are carefully prepared in close cooperation with the sponsor in accordance with the demographic situation of drug's target (indicated) and/or current actual patient group
- "«Grindeks»" is responsible for all stages of testing, including suggested amendments to the leaflet and test, and for all the listed items below
Readability tests run for four to six weeks and cover the following areas:
- Writing the protocol
- Writing the test questions
- Preparing the questionnaires
- Defining the target group
- Enrolling of volunteers into the target group
- Checking the questionnaire with a pilot test involving 1-3 patients
- Performing interviews with at least 20 patients in two separate rounds
- Performing statistical analyses
- Correction of the patient leaflet
- Repeating the interviews
- Evaluation
- Writing the summary
- Preparing the document for submission to the authority
- Translation of the document into English
- Loan translation of the approved patient leaflet
