PIL User Testing
Patient Information Leaflets (PILs) are required for all medicinal products in Europe and must be tested to establish readability. RApport has run user tests since they became mandatory in 2005.
We operate a standard process for user testing which involves a small pilot test followed by two Rounds of testing, with 10 subjects in each Round.
With our experience we are able to advise you on the layout and wording of your PIL from the start and are happy to draft your PIL from the SmPC. All you need to do is help us decide the most important key safety messages for the patient so that we can adapt the test to the product. We can also arrange the artwork and design of the PIL if required.
We will deliver a submission ready report including the information required by the European Regulatory Agencies. We are also able to provide bridging reports if you have user testing reports for other products with similar text and layout. These can sometimes be used instead of a full Test.
A key milestone in managing a product’s lifecycle may be the availability without prescription (Over the Counter). Wider healthcare access and increasing healthcare costs means the availability of non-prescription medicines with good safety profiles, is increasingly important to consumers so that they can self-manage non-serious health conditions.
RApport can help you identify potential switch candidates within your portfolio and their potential markets. Furthermore, RApport’s hands on experience of managing switches across multiple countries across both Europe and the globe, will be invaluable given the challenge faced by different regulatory and healthcare environments.
Evaluation and feasibility of potential switch products and markets;
Liaison with regulatory agencies including Scientific Advice to discuss a potential switch application;
Management of the submission through to approval including any oral hearings if required;
User testing of the leaflet and the proposed packaging, if required, to support the switch application;
Common technical document compilation; Modules 1-5 in ICH regions and beyond