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Since 2005, patient information has required to be user tested, in accordance with Article 59(3) of Council Directive 2001/83/EC. Spectrum was among the first regulatory service providers to develop a readability testing service. Our combined experience and learning gained from over 800 PIL tests is applied to each new PIL project to produce clear and user-friendly product information, labels and instructions for use (IFU) that effortlessly pass readability testing.
We are experts in, and can help you to meet, the requirements of writing PILs in compliance with current EU templates and guidelines (for Centralised, Decentralised, Mutual Recognition and National Procedures). If you choose to write your PIL, you will still benefit from an integral and fundamental part of our service which is a critique of a PIL before testing gets under way, in order to remove any foreseeable obstacles to readability and understanding. After this initial step, our service includes:
- Protocol and questionnaire development
- Recruitment and screening to identify eligible participants
- Pilot testing with an expert panel
- Participant interviews
- Submission-ready test reports and bridging reports
Spectrum offers testing on all forms of patient information for all product types, including devices, and dosage forms. We can perform linguistic review/translation, testing and reporting in most major European languages besides English
For companies with large portfolios, Spectrum develops testing and bridging strategies aimed at reducing time and costs.
To find out more about these and other patient leaflet services from Spectrum, please call us on +44 (0)1403 320280 or contact us by email.
March 11, 2013 No Comments