Changes to the European legislation made in 2004 introduced the legal obligation on all marketing authorisation holders to ensure that all patient information leaflets reflect the results of consultations with target patient groups (user testing). With over 700 patient information projects completed successfully across the UK, Europe, the Middle East and the USA, we have depth of experience in this field and can engage our team very quickly.
Here at PDS we can help you with:
- Patient Information readability testing
- Writing of Patient Information Leaflets (PILs)
- Writing of Packaging Information
- Educational materials and healthcare professional instructions
- Consumer testing
We have an extensive database of participants, including specific patient groups across therapeutic areas.
Best practice indicates that there are six main sections of a PIL and they are:
- Identification of the medicine
- Therapeutic indications
- Information that is necessary before taking the medicine
- Description of side effects
- Additional information – such as excipient details, name and address of the manufacturer.
Here at PDS we can advise our clients on the best practice for design, layout, readability and structure and as a result will ensure a high quality PIL is achieved assuring you of a successful outcome in the test.
Here are some Top Tips from the MHRA on Patient Information Leaflets
- Include an index (especially if you are writing a booklet or user guide.)
- Make sure the text size is as large as possible – Arial 12 point is ideal and make good use of white space.
- Use bullet points – long lists of side effects are frightening.
- Group side effects in order of seriousness
- Make sure related information is located together and not split over different columns or sides of the leaflet.
Working with PDS means you have a highly respected and trusted partner, with experience in a broad range of therapeutic areas and product types. You will avoid commonly made mistakes in designing your PIL, before submission to the Marketing Authority.
Got a question? Just call +44 (0) 1476 512395 or email firstname.lastname@example.org