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Quality Declaration

In practice:
- New MA legislation
- Substantial changes
- MA Renewal
 
     
 

Our responsibility :
DPMI
will be in charge of the editing or rewriting of your Patient Information Leaflets according to the current legislation and recommendations from the QRD group of EMEA, DPMI will give you the option to either providing us with the graphics or choosing between several of our personalized graphics, DPMI also offers you solutions for the printing of your leaflets.


Our methods :
- selection of suitable participants
- a pilot phase followed by two test rounds
- analysis pf the results after each round and changes to the leaflet between each round if needed
- goal : a leaflet passes a test round if for at least 90% of the questions the information is located and
if in at east 90% of these cases the information is understood.

Abridged Readability test :
DPMI will use asa basis a test previously conducted on a leaflet taht does not differ form the one to
be tested, apart form certain key messages for sale use with the particular medicine in question.
We will then set focus on these key messages concerning the safe use. This type of test is conducted
according to the same quality standards as the usual readability test but the number of questions and
partipants will be reduced.

Bridging :
When two leaflet are sufficiently similar in both content and layout, the readability test can be
replaced by
bridging, Bridging means to use the results of a test conducted on the leaflet of a similar
product, In bridging, a succussful user test on one Patient Information Leaflet (the "parent" PIL) can
be used as a justification for not testing other similar leaflets ("daughter" PILs).


DPMI offers to evaluate your product portfolio in order to minimize the number of tests to be conducted
(please send your requests to:
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