The Workshop

Readability testing based on the Australian interview method in the light of the revised Readability Guideline
Date:	Tuesday, 16, September, 2008
Led by:	Beate Beime, Managing Director, DIAPHARM Clinical Management GmbH Klaus Menges, Director and Professor, Head of Scientific Quality Assurance, Federal Institute for Drug and Medical Devices (BfArM)
About the workshop:	The interview method is the only example described in detail in the revised Readability Guideline. This method is the most widely accepted despite any further outlining of pre-requisites, standards of performance and validation of outcome criteria. One central key issue is the questionnaire which should mirror the safety profile of a product but also determines the result and percentage of acceptable answers. Last but not least, the authority has to evaluate the report on consultation and to decide whether a package leaflet would be legible, clear and easy to use. This workshop is designed to help professionals tackle difficulties in the assessment of questionnaires and identify the most relevant changes based on the revised Readability Guideline.

Workshop agenda
13:30	Registration
14:00	Session 1: Identify the most relevant changes based on the revised Readability Guideline Requirements of the Competent Authorities Standardised / validated implementation of the interview method Aspects of design and layout (group exercise)
15:00	Coffee break
15:30	Session 2: The pass criterion as an example for assessing reports Evaluation of most critical aspects (group working) Sharing identified problems Pros and cons of the evaluation methods
16:30	Close of workshop
About your workshop leader:
Beate Beime	Beate Beime is a veteran in PIL user testing in Europe and a leading consultant for validated readability tests in Germany and the United Kingdom. As a graduated biologist she also coordinates preclinical and clinical trials for the pharmaceutical industry. Beate Beime is managing director of Diapharm Clinical Management GmbH, Oldenburg (Germany).
Dr. Klaus Menges	Dr. Klaus Menges is currently responsible for process organisation and scientific Quality Assurance at BfArM. This includes his expertise in writing medical information for the public based on his former responsibilities. In this role he became familiar with readability testing, especially with its principle assessment aspects. Klaus is a German representative in the Telematic Implementation Group for e-submission (TIGes) and their subgroups, e.g EURS and PIM, and represented BfArM in the two Assessment Training Workshops on Readability Testing Reports at EMEA.
Diapharm	Diapharm is a service provider for the pharmaceutical industry. A team of more than 80 specialists provides solutions for all medical, regulatory and pharmaceutical tasks – from strategic consulting, via marketing authorisations up to pharmacovigilance services. Main fields of activity are medicinal products, food supplements, medical devices and cosmetics. The Germany-based company is present throughout Europe with several partners.