Readability test Module 1.3.4 (RUT) safe timelines PiL M.1.3.4.

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.

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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.»

May 25, 2019

Readability Test

Module 1.3.4

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 readability test in the UK, France, Germany, Belgium, Sweden, 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 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

Knowhownow is situated only 40 minutes from European medicine Agency’s new location in Amsterdam with it’s canals and lovely bridges.

Temporary location European medicine Agency

Dutch article.

test de lisibilite

IFU testing

IfU testing in the USA for FDA admission

knowledge-database

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 6-years old contribution to Wikipedia on the readability subject

Why Knowhownow

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

Services

Timeline:

– 4 weeks

Services :

– Independent review of leaflet and mock-up.
– Minor rewriting of the leaflet.
– 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.
– Merging of all documents into 1 PDF for submission (m.1.3.4)
– 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

Additional services:

PIL/Mock-up
– 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

Mock-up m.1.3.4.

2006

Experience since 2006

1000+

Tested Leaflets

100%

Success rate

For a readability test find our fieldwork sites in

(not limited to):

United Kingdom: London, Bishops’ Stortford

France: Colmar

Italy: Milan

Sweden: Umeå, Malmö

Germany: Kleve

The Netherlands: Nijmegen, Mook

Belgium: Liège

National authorities dealing with readability test

Netherlands:	Leesbaarheidstest	CbG-MeB	www.cbg-meb.nl
Germany:	Lesbarkeitstest	Bfarm	http://www.bfarm.de/
Denmark:	læsbarhed test	Danish Health and Medicines Authority	www.laegemiddelstyrelsen.dk
France:	test de lisibilité	ANSM	ansm.sante.fr
Finnland:	luettavuus testi	Fimea	www.fimea.fi
IrEland:	Readability test	HPRA	www.hpra.ie
Italy:	test di leggibilità	AIFA	www.agenziafarmaco.it
Norway:	lesbarhet test	Norwegian Medicines	www.legemiddelverket.no
Spain:	test de legibilidad	SAMH	www.aemps.gob.es
Sweden:	läsbarhet testet	Medical Products Agency	www.lakemedelsverket.se
UK:	Readability test	MHRA	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.