The collaboration between GPMed, Society for Pharmaceutical Medicine in Austria , and the Austrian regulatory agency AGES has been very successful – an obvious, highly relevant common interest is to perform clinical research at the best possible quality. There have been many educational events together with members of the agency where various aspects of clinical research have been addressed. But mistakes are unavoidable when performing clinical trials. It is only by exchanging experience and also expectations that we can improve and learn.
An upcoming regulatory inspection normally creates not too positive feelings by the inspectee, but rather anxiety or annoyance – although it should be seen by its real intent, i.e., to secure highest quality, most of all in the interest of the study patients.
In order to overcome this somehow negative connotation of an inspection, DI Dr. Christa Wirthumer-Hoche, Head of AGES Medicines and Medical Devices Agency and Chair of the EMA Management Board, invented together with GPMed the AGES Best Inspectee Award. This award is given every second year to the investigational site that proved the highest quality during a regulatory inspection. The site is selected by GPMed board members out of a sample of anonymized inspection reports provided by AGES. Hereby a regulatory inspection can suddenly be the starting point for winning an award for excellent performance – definitively a positive and highly rewarding experience.
In 2017, the winner was Doz. Dr. Johannes Clausen, Ordensspital Elisabethinen in Linz, department for stem cell transplantation. In his speech, he remarked the basis for being successful is a well-organized set-up, experienced staff, clear responsibilities and strong commitment – and overall a joint team willingness to strive for highest possible quality. He felt very proud that he and his team received this award, and stressed that this is an extra stimulus for even higher clinical research involvement.