Country: SLO
All medicinal products that are placed on the Community market are required by Community law to be accompanied by labelling and Package leaflet (PIL). In accordance with European directive 2001/83/EC as amended by directive 2004/27/EC “The package leaflet shall reflect the results of consultation with target patient groups to ensure that is legible, clear and easy to use”.
According to the Slovenian national legislation all medical products that obtained marketing authorisation in the state prior to implementation of the “new legislation” (8th April 2006) have to be tested for readability by 8th April 2011.
Clinres Farmacija d.o.o. has been the first performer of readability testing in Slovenia. Our services are performed by an expert team including interviewers, medical writers, regulatory experts and graphic designers.
We offer:
- Preparation of Package leaflet from the Summary of product characteristics
- Complete performance of readability testing including:
- Review of your existing PIL and proposals for changes
- PIL graphic design advice and mock-up creation when necessary
- Preparation of test questionnaire
- Recruitment of participants
- Pilot testing (3 – 6 participants) to optimise the questionnaire and include improvements at an early stage
- 1st round testing on 10 participants
- Evaluation of 1st round results, review of the PIL and proposal of eventual amendments
- 2nd round testing on 10 participants to re-test the PIL
- 3rd round testing, if results don’t achieve regulatory requirements
- Preparation of final report in English language to be included in the module 1.3.4 section - Company portfolio assessment to bridge the results of user testing
- Preparation of bridging reports/studies
- Graphic design consultancy
- Preparation of faithful translations
We are able to provide our client the final report in 4-5 weeks after preparation of the revised readability PIL. Our user testing methodology is based on face to face, recorded interviews performed in a quiet but relaxed environment. One interview lasts approximately 45 minutes.
Our work does not stop when the final report is delivered. We provide our client also post submission support when this is required by the competent authority.
Our value is to combine expertise, high quality service, speed, and our client’s needs with fair price.
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