Readability Test PiL for your Module 1.3.4

Knowhownow – readability test professionals since 2006

 

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.

Readability test Leesbaarheidstest Lesbarkeitstest Test di leggibilità Teste de lisibilité Läsbarhet testet

 

 

Readability test

 

Services Readability Test Pil – PIL user tests

Timeline:

  • regular 8-10 weeks
  • expedited 2-4 weeks (subject to additional fee)

Services:

  • Submission-ready 1.3.4 documents (eCTD)
  • Timelines possible between 2 and 10 weeks (respecting your clock-stop slots)
  • Design and printing of mock-up for testing purposes
  • Testing possible for all European authorities
  • All PL´s, Rx, OTC and hospital products
  • CP and MRP
  • Bridging services
  • Testing for Patient Instructions, Instructions for Use
  • Experience with decades of interviewing respondents which results in a pre/test assessment of the readability of the PIL

Additional Services:

  • Pilot testing of PL
  • Pilot testing of protocol
  • Mock up design
  • Pre-test assessment
  • 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).
  • Completion of QRD Bridging proposal

Interested? Ask for quotation

 

2006

Experience since 2006

1000+

Tested Leaflets

100%

Success rate

For a readability test find our fieldwork sites in (but not limited to):   

 

United Kingdom: London, Bishops’ Stortford

 

France: Clichy, Paris, Colmar

 

 SwedenUmeå, Malmö

 

Germany: Dusseldorf, Kleve

 

The Netherlands: Nijmegen, Mook

 

Belgium: Liège

National authorities dealing with readability test

Netherlands: Leesbaarheidstest CbG-MeB https:\\www.cbg-meb.nl
Germany: Lesbarkeitstest Bfarm https:\\www.bfarm.de/
Denmark: læsbarhed test Danish Health and Medicines Authority https:\\www.laegemiddelstyrelsen.dk
France: test de lisibilité ANSM https:\\ansm.sante.fr
Finnland: luettavuus testi Fimea https:\\www.fimea.fi
IrEland: Readability test HPRA https:\\www.hpra.ie
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
UK: Readability test MHRA https:\\www.mhra.gov.uk

 

Readability tests

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.