09.15 Registration and morning coffee
09.45 Welcome from the Chairman and introduction to User Testing
Borislav Borisov, Managing Director, Prescriptia LLC, Bulgaria
10.00 The history of the Directives relating to User Testing
- Guidance on testing patient information leaflets has been available in Europe since 1999. From 1st July 2005 legal provisions were introduced in the UK to mandate “User Tested” PILs for new applications. The presentation reviews the key guidance documents shaping the format and success criteria for user testing. It also highlights the key challenges faced by applicants today from a pre and post-submission perspectives, based on several experiences with UK submissions.
Diana A. Taylor, Parexel, Germany
11.00 Coffee and networking break
11.30 The objectives and guidance of Competent Authorities – What do the Authorities look for?
• Experiences with the package leaflet from the view of the patients
• Requirements of Article 59 and 61 of Directive 2001/83 and the corresponding guidelines “Guidance concerning consultation with target patient groups for the package leaflet” and Readability Guideline
• How have the Member States implemented the requirements of the Directive 2001/83 into national law
• Methods for the readability test (Interview, written procedure)
• How to file the readability test in the application for a marketing authorisation (national procedures, MRP, DCP).
• Under which conditions is a readability test not necessary
Britta Ginnow, Head of National Authorisations, The German Pharmaceutical Industry Association (BPI), Germany
12.30 Experiences of user testing to date
• The need for user testing of patient information leaflets
• Basic assumptions for patient consultation and readability testing
• Order of events in a readability test
• Patient target groups and testing methods
• Experiences from readability tests in Germany
Marion Schaefer, Institut für Klinische Pharmakologie, Germany
13.15 Lunch
14.15 Aims and progress of harmonising procedures throughout the EU
Diana A. Taylor, Parexel, Germany
16.15 What is a PIL Designed to do and does it achieve this aim?
• A mandatory document
• A legal disclaimer
• Information for the patient
Dave Trotter, Head of User Testing, Unicus, UK
17.15 End of Day One
17.30 Cocktail reception for speakers and delegates
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