07/21 Australian expert at BfArM-Dialogue about usable package leaflets
Press release 21/2007
The most appropriate preparing of package leaflets will be again the focus of a conference which is organised by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) taking place on Tuesday, September 11th, 2007, at the Wissenschaftszentrum of Bonn within their series of events „Das BfArM im Dialog“ actually announced as „User Testing – alternative methods and assessment in Europe“.
Having in force the new requirements for preparing package leaflets nearly two years a view back as well as a future outlook shall be undertaken: Experience gained throughout that time illustrate problems of different implementation and difficulties in establishing a method of testing which was not developed in Europe but in Australia. Especially in this regard BfArM expects comments from Prof. David Sless (Communication Research Institute, Melbourne, Australia) due to his long-term experience in preparing usable package leaflets.
As the interview method should not be the one and only method of testing BfArM has invited speakers who will report about alternatives developed specifically for and within the European context.
The new legislation has to be implemented in all Member States. Therefore, the position of all other Member States as well as of the European Agency EMEA must be considered. The Guideline on Readability of the label and the package leaflet of medicinal products for human use, so called Readability Guideline, aims to achieve a most appropriate and harmonised implementation. The conference will inform about the current status of revision of that document.
The Head of BfArM, Prof. Reinhard Kurth identifies in this dialogue „an important contribution to prepare package leaflets in a way that patients will understand and can act appropriately without reducing the required set of information“. To achieve this ambitious aim all parties involved and responsible for have to collaborate closely and confidingly“, Kurth said.
The detailed program can be downloaded at BfArM in Dialogue: User Testing - Alternative Procedures and Assessment in Europe
Year of issue: 2007