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Informa Life Sciences
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| Comprehensive User Testing of the Patient Information Leaflet |
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Tue 15 May 2007
- Wed 16 May 2007
Danubius Hotel Gellert, Budapest, Hungary
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Who Will Attend?
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Regulatory Affairs Managers andExecutives with responsibilities for new Marketing Authorisation Applications
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Those who have a portfolio of currently marketed products which need to be brought into compliance
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Packaging and Labelling Managers
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Country Registration Managers
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User Testing Consultants
…and many more
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Don't Miss
Our full day practical workshop, including break out sessions and discussion panels to make sure you come away with all your questions answered and take back best practice to your company.
Led by: Dave Trotter, Senior User Testing Consultant, Unicus , UK and
Alison Turner, Product Information & User Testing Consultant , Unicus , UK
- Creating a “Parent PIL”
- Breakout 1: Review of an existing document
- Group presentations and discussion
- Who does the testing and how?
- Breakout 2: Preparing a questionnaire
- Breakout 3: Introduction and preparation for role play
- Conduct role plays
- Completing the process
- Open forum for questions
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Key Presentations
Klaus Menges, Scientific Quality Assurance in the Unit "Strategy and Plannings", BfArM, Germany
Marion Schaefer, Professor and Lecturer at Charié University Medicine Berlin, Institute of Clinical Pharmacology, Germany
Dave Trotter, Senior User Testing Consultant, Unicus, UK
Angela Gisby, Director, Spectrum Regulatory Solutions, UK
Diana Taylor, Medical Writer & In-house Instructor, PAREXEL, International GmbH, Germany
Alison Turner, Product Information & User Testing Consultant, Unicus, UK
Borislav Borissov, Managing Director, Prescriptia LLC, Bulgaira
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