09:00 Registration and coffee
09:30 Introduction from the Chair
Klaus Menges, Scientific Quality Assurance in the Unit "Strategy and Plannings", BfArM, Germany
09:40 Patient information and participation in decision making
- Technical opportunities of providing information to patients
- Suggestions for future developments
Borislav Borissov, Managing Director, Prescriptia LLC, Bulgaira
10:20 Readability testing report - Assessment from Regulator’s viewpoint
- The revision of the Readability Guideline
- Different ways of testing
- Experience after the first 18 months
- Consequences from an Agency’s perspective
Klaus Menges, Scientific Quality Assurance in the Unit "Strategy and Plannings", BfArM, Germany
11:20 Coffee and networking break
11:50 Communicating with the patient across the lifecycle of a drug - from the clinical trial to the PIL
- How are the contents of a Subject Information and a PIL comparable?
- Differences between the participants in a clinical trial and patients using a drug
- User Testing and a subject's consent to participation in a clinical trial - differences and similarities of the two processes
Diana Taylor, Medical Writer & In-house Instructor, PAREXEL, International GmbH, Germany
12:30 Lunch
Case studies: Practical experiences with UT of the PIL
3 companies present detailed case studies on this topic.
13:40 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, Professor and Lecturer at Charié University Medicine Berlin, Institute of Clinical Pharmacology, Germany
14:40 Successful filing of User Tested PILs in the EU
· When is user testing required during the product life cycle?
· Identifying key issues
· Points to consider for user testing reports
· The review process and Regulatory Agency feedback
Alison Turner, Product Information & User Testing Consultant, Unicus, UK
15:40 Networking break
16:10 Lost in translation? Realities, practicalities and solutions in User Testing
- A user testing consultant’s experience in the UK
- PILs come in many shapes – user testing different forms of patient information
- A PIL’s journey through user testing: Use of case studies to demonstrate the challenges and solutions
Angela Gisby, Director, Spectrum Regulatory Solutions, UK
17:10 Panel session
This is your opportunity to discuss areas of concern with our expert speaker panel. Ensure you come away with all your questions answered and take back successful User Testing strategies to your company. |