Helmut SchützBEBAC Consultancy Services for Bioequivalence & Bioavailability, Austria
Helmut Schütz is a chemical engineer by training and worked in the generic industry as well as for twenty years in Austria’s first Contract Research Organization, where he established a Laboratory Information Management System certified according to the rules of Good Automated Laboratory Practices, holding senior management positions, most recently as head of the biostatistical department. Since 2004 he is an independent consultant in the domain of comparative bioavailability studies and since 2022 he is a lecturer at the Institute of Medical Statistics of the Medical University of Vienna.
He has extensive experience with GCP/GLP, bioanalytics, pharmacokinetics, and biostatistics. His professional career spans 43 years and more than six hundred bioavailability studies. He participated in the BioInternational conferences (1989 – 2005), Global Bioequivalence Harmonisation workshops (2015 – 2022), is a co-organizer of the BioBridges conferences (since 2016), and maintains the global BEBA Internet Forum (since 2004). He gave more than 300 presentations on topics related to bioequivalence.
Amongst others, he is a member of the European Federation for Pharmaceutical Sciences (EUFEPS), the International Pharmaceutical Federation (FIP), the American Association of Pharmaceutical Scientists (AAPS), the International Biometric Society (IBS), the International Society for Clinical Biostatistics (ISCB), the European Network for Business and Industrial Statistics (ENBIS), the Österreichiche Pharmazeutische Gesellschaft (ÖPhG)  and the Arbeitsgemeinschaft für angewandte Humanpharmakologie (AGAH) . Since 2015 he is a member of the editorial board of »Drugs in R&D«.
Helmut Schütz is associated with the following events / presentations:
Event: »Bioequivalence: New trends and recent discussions« Presentation: »ICH M13A: Testing for multi-group and multi-center – effects in BE trials: Statistical considerations and consequences for interpretation«