Pharma-EU User Testing
of PILs
Our experience with user testing
began on 10th November 2005, the beginning of the requirement. Pharma-EU
methodology conforms to all regulatory agencies’ criteria and
is validated. All tests are guaranteed to be accepted.
 Pharma-EU PIL User Testing Services
- User readability testing and consultation with patients
about the package information leaflet is performed with the most
up to date guidance. The MHRA has taken the lead in reforming PILs
and will require all PILs to be user tested by July of 2008.
- Our user tests are validated by BfarM, MHRA, MEB, NAM,
SUKL, DKMA, Ravamiamet, Agmed, ISS, NIZP, SUKL(Slovakia) and the
MPA.
- Our tests are conducted with strict quality control measures
by medical professionals and offered at a competitive rate.
- We can perform readability testing of PILs in English, German,
French, Swedish and Czech. All reports are in English, ready for
submission.
- Our methodology for user testing is validated by EU national
agencies, as well as EMEA.
- We use EPFIA’s guidelines as the base for our methodology,
which was developed with guidance from MEB, SUKL and the MHRA.
- Our tests are performed in the UK, Germany, Czech Republic,
Sweden and Poland. The highest measures of quality control ensures
valid
test results.
- The end result if a high quality Package Information Leaflet.
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.
- 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
Quality Control
- Pharma-EU Interviews are performed by trained medical professionals.
- All
interviews are recorded and checked for accuracy.
- All data is crosschecked
by a qualified person.
- Statistical Analysis is performed using
Macros.
- All reports are validated and signed off
and on by 2 regulatory affairs professionals to ensure acceptance
by authorities.
- Our Readability User Tests are guaranteed through
to the first marketing authorization and we are available for immediate
comments
for the life of the test.
- Our reporting criteria is validated by EMEA and the MHRA.
Please contact us for more information.
|
