Readability test - M.1.3.4 PiL testing - IfU
Readability test : Legimate and clever testdesigns to save you costs conducting your readability test (M.1.3.4). Deploy focus tests and bridging wherever possible.
Knowhownow Readability test
Directive 2001/83/CE amendée par la Directive 2004/27/CE:
« The package leaflet shall reflect the results of consultations with targets patient groups to ensure that it is legible, clear and easy to use and that these results of assessments carried out in cooperation with target patient groups are also provided to the competent authority.»
Readability Test PiL
Knowhownow – readability test professionals since 2006
Readability test Leesbaarheidstest Lesbarkeitstest Test di leggibilità Teste de lisibilité Läsbarhet testet
Knowhownow is a European Group of Readability test professionals, based in the Netherlands. Since 2006, we have guided over 1000 package leaflets to submission. Knowhownow conducts your PIL user tests in the UK, France, Germany, Belgium, USA and the Netherlands. We are well known for our state of the art quality and flexibility. We conduct our readability tests and IfU tests on patient instruction leaflets by guidelines issued by MhrA, EMA, AIFA, CBG-MEB, PEI, Bfarm, MSNA, FAGG.
Furthermore we have quite a track record concerning our success rate: 100% of our PIL user tests have been validated by various authorities. We continue to receive sincere compliments from the authorities on the quality of our extended reports. Submission ready for your M.1.3.4.
Knowhownow is situated only 45 minutes from European medicine Agency’s new location in Amsterdam with it’s canals and lovely bridges.
Temporary location European medicine Agency
Flatten the curve – corona – social distancing
Let op: De komende onderzoeken zullen on-line plaatsvinden. Het belangrijkste onderdeel van ons werk is ervoor te zorgen dat mensen begrijpen hoe ze een medicijn veilig en juist gebruiken. Dat doen we door het aan de mensen zelf te vragen. Natuurlijk kan dat de...
test de lisibilite
Since we all stand for save usage of medicines, we decided to start publishing our knowledge-database in a blog. It is loaded with valuable information on how people read and look for information. Use it, it contains raw data straight from the source: people without any medical knowledge. People using your products.
Congratulations to our 12-years old contribution to Wikipedia on the readability subject
- In service pre-recommendations on PiL
- In service screening for cost-effective alternatives : bridging study, focus test
- Validated, reliable readability user testing
- Final report in English ready for submission
- Respectable track record
- Testing in Sweden, UK, Germany, France, Belgiun, The Netherlands and Italy
ervices Readability Test Pil – PIL user tests
– regular 6 -7 weeks
– expedited 4 weeks (subject to additional fee)
– eCTD friendly dossier
– EMA and MHRA compliant reporting.
– Merging of all documents into 1 PDF for submission (m.1.3.4)
– Independent review of leaflet and mock-up.
– Rewriting of the leaflet upon request.
– Recruitment of 20 fresh – native users / consumers
– Preparation of protocol / questionnaire
– Arranging interview facility, all 20 interviews are held under the same conditions. Any disturbances are documented.
– Conducting of the interviews.
– Reporting within 2 weeks after fieldwork
– Printing of the mock-up in small batches
– Secure AVG / GDPR
– Documenting of individual detailed social demografic data of respondents (though not mandatory yet, we experience this is required by EMA and MHRA assessors more and more often).
– Documenting subjective ease of finding, PEI mandatory
– Pilot testing of PiL or protocol
– Mock up design: we comply with all National Agency Specifications as well as your company’s design specifications
– Review of the Word text. Amendments are based on technical readabilitity, use of laymen terms, thousands of interviews etc. All in order to optimize readability (i.e. legible, clear and easy to use). Generally prioir to testing.
– PIL reformatting to current QRD
– 3D mock-up preparations
Experience since 2006
For a readability test find our fieldwork sites in
(not limited to):
United Kingdom: London, Bishops’ Stortford
Sweden: Umeå, Malmö
The Netherlands: Nijmegen, Mook
National authorities dealing with readability test
|Denmark:||læsbarhed test||Danish Health and Medicines Authority||https:\\www.laegemiddelstyrelsen.dk|
|France:||test de lisibilité||ANSM||https:\\ansm.sante.fr|
|Italy:||test di leggibilità||AIFA||https:\\www.agenziafarmaco.it|
|Norway:||lesbarhet test||Norwegian Medicines||https:\\www.legemiddelverket.no|
|Spain:||test de legibilidad||SAMH||https:\\www.aemps.gob.es|
|Sweden:||läsbarhet testet||Medical Products Agency||htps:\\www.lakemedelsverket.se|
For manufacturers of medicines, Europe requests to present the leaflet in one language to consumer panels. When we test a package leaflet for readability, attention is paid to findability, comprehensibility and applicability of the information. The readability test may be a reason to further improve a package leaflet.
The readability test is a mandatory part of the European registration procedure and the test results are included in the registration dossier. Knowhownow tests package leaflets according to a fixed procedure that is based on the guidelines of the European Commission. Your contribution is very important.