Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

+420 224 910 672

(from 09.00-17.30 CET)

+420 226 251 459

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

+420 224 910 672

(09.00-17.30 CET)

+420 226 251 459

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

Readability Testing and Bridging

Readability of patient information leaflets

  • All submission procedures covered (CP, DCP/MRP, national)
  • Experience with all therapeutic groups, from simple generic to complex biotechnological products
  • We cover all EU languages

4,500 +

readability tests and bridges performed

2,450 +

PIL and package mock-ups created

100%

success rate for our readability tests

We follow the procedure set by EMA

Leaflet review

  • The leaflet review includes QRD (Quality Review of Documents) compliance, formatting, terminology and readability
  • Harmonisation across a product group

Step 1

Step 2

Questionnaire creation

  • The questions are prepared to cover key safety messages
  • Wording formulated to create an imaginary scenario

Mock-up creation/review

  • Prepared in line with EU requirements
  • Finalised in 2-3 business days

Step 3

Step 4

Participant selection

  • Testing: 2 rounds, 10 participants each
  • Demographics (age, gender, education level) customised when needed, each participant literate in the tested language

Mock-up creation/review

  • 1-on-1 recorded interviews with trained coordinators
  • 45 minutes allowed for the interview, voice recorded
  • Data saved for analysis
  • Complete analysis of the results after each round

Step 5

Step 6

The results

  • Participant answers are assessed and scored.
  • A leaflet passes a test round if the information is located for at least 90% of the questions, and if the information is understood in at least 90% of these cases. In the rare case of low scores during the first round of testing, we suggest revisions to improve the leaflet.

The report

  • After the test, data is gathered and the final report is created. A spreadsheet with participant answers and data is provided.

Step 7

The report includes:

  • Protocol followed, method used
  • Demographics (age, education, gender)
  • Questionnaire
  • Quantitative and qualitative summary of the results
  • Discussion of the problematic areas and/or participant comments
  • Changes made to the leaflet
  • Mock-up

If any query arises, we would defend the report in front of the concerned Health Agency free of charge.

We aim to minimise the number of tests you need to perform and expedite your approval process.

We will look at your portfolio, assess the leaflets and advise on the best approach.

We cover the three possible alternatives:

Bridging Report

A Bridging Report is created to justify why a leaflet (the “daughter PIL”), does not need to be tested by linking it to a successfully user tested leaflet (the “parent PIL”). It applies to leaflets that are very similar in content, style and layout.

A Bridging Report is more effective when a strategy is established.

  • Indications (identical or similar)
  • Headings and subheadings
  • Placement of the information (messages to be in same location)
  • Similarity for the key messages for safe use and the writing style
  • Ensuring that the mock-up is as similar as possible (dimensions, graphics, font, etc.)

In case the “daughter PIL” is based on 2 “parent PILs”, a Double Bridging Report can be performed. This happens, for example, if the “daughter PIL” has similar text to “parent PIL A” and a similar format to “parent PIL B”.

Bridging Statement

A Bridging Statement is created to justify why a leaflet (the “daughter PIL”) does not need to be tested by linking it to a successfully user-tested leaflet (the “parent PIL”). It applies to leaflets that are almost identical in content, style and layout.

Focus Test

A Focus Test is a combination of testing and bridging. It can be performed when there is a similarity between the leaflets but with some key differences in the safety information that cannot be justified by a Bridging Report alone. The differences are tested, following the standard process of a Readability Test, and the remaining text is bridged by a Bridging Report.