CRED SMPC 2024

Common problems

• Failure to question patients about critical safety issues

• Failure to take account of the views of patients expressed during the test

• Using leading questions or closed questions

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Bridging studies

• Key messages for safe use must be similar

• The more complex PIL should be tested

• Bridging study should cover key messages in both products and how these are covered in the test carried out

• May need to bridge to more than one leaflet (e.g. for content and layout)

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