Pharma-EU provides PIL patient consultations
using the latest EMEA guidelines. The testing is designed to comply
with all competent authorities in the EU.
Pharma-EU PIL User Test Methodology Involves:
- Review of the PIL and suggested revisions. The PIL is reviewed
by an experienced PIL writer and test administrator. This is to
ensure the PIL is most likely to pass a user test and complies
with current guidelines.
- Creation of Questionnaire.
- Recruitment of target-group participants who might be likely
to be users of the medication in question. Twenty-five participants
are recruited to suit the widest range of demographics available
and who are considered to be within the target group. Participant
selection is based upon criteria complying with the guidance of
the MHRA, to ensure valid test results. Participants selected are,
wherever possible, people who do not use written documentation
at work, are not over-educated (the maximum education of a participant
is 4 years of University) and who admit to having had difficulty
with PILs in the past . Participants are excluded from the test
if they work in medical, pharmaceutical or media industries.
- A preliminary round of testing is performed to identify possible
major problems with the PIL that should be addressed before the
- The results of this testing are discussed with the MA holder.
Revsions are connsidered and discussed if needed.
- 1st round testing is performed with 10 participants.
- 1st round results are analyzed and reviewed for quality.
- Any revisions to the PIL are suggested to the MA holder
- 2nd round testing is performed with 10 participants
- If the PIL achieves a satisfactory test result based on the 2nd
round testing, the final report is created in English, ready for
submission to the authorities. If the PIL does not achieve a satisfactory
result, 3rd round testing may be necessary.
- Creation of the final report, ready for submission
- Bridging results of tests to cover multiple products
Testing Providers for: