Frequently Asked Questions
The navigation links on the left allows you to click on each question and you will be directed to the relevant answer:
Why do I need to User Test?
EU legislation taken from Directive 2001/83/EC (as amended) requires Marketing Authorisation holders to ensure that patient information is clear, legible and easy to use. One method for ensuring patient information meets these requirements is to carry out user testing where required..
What is bridging?
Bridging allows applicants to review their product portfolio and only submit user testing where absolutely necessary. This helps to reduce the costs for the applicant and to reduce the amount of unecessary testing. We are experienced at helping clients determine their specific user testing needs.
Can I volunteer to take part in a User Test?
Due to the nature of the data we gather it is necessary to conduct the user test face to face. We arrange workshop style days throughout the year and at a number of locations where you can turn up and take part in a user test. These are friendly, open meetings of like-minded people who wish to improve the way patient information is presented. We try to make the individuals feel as comfortable as possible, with the provision of tea and biscuits (or soft drinks if you prefer). The people conducting the user tests are experienced individuals who are very familiar with the Patient Information Leaflets being tested and are there to observe the way you handle the leaflet and locate information on it. Please rest assured that this is not conducted in a strict test style and we are not trying to catch anybody out.
Can I conduct a User Test for you if I have already taken part in one?
Unfortunately we do not encourage people to take lots of User Tests. The main reason for this is because it would not take very long to become specialised at working with Patient Information Leaflets and this could adversely affect results. However, if you haven't taken part in one for at least 6 months then you may be eligible.
How much experience do PIL2005 have?
We have been conducting User Testing now since November 2005 for various clients including Abbott Laboratories and UCB. Feedback from regulatory authorities, interviewees and clients has been extremely positive. In May 2006, we formed a partnership with a respected Regulatory Affairs consultancy called Independent Pharma Consultants, who complement our experience with PIL design and writing. And in 2009 Independent Pharma Consultants fully acquired PIL2005.com.
Can members of Patient Groups help?
Most definitely! In fact we actively encourage patient groups to become involved as they have experience of particular disease areas and provide valuable information. The only requirement we have is that they should not carry out a User Test on a product they are very familiar with, have taken in the past or are currently taking.
If you have any further questions please do not hesitate to contact us.