Patient Consultation Methodology

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 testing.
• 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

Preferred Readability Testing Providers for: