Pharmaceutical industry in
transition: The importance of
AI for quality & efficiency

In the past, she held - among other things - the position of deputy head from 2015 to 2020 and until 2022 the comm. Head of the German GLP Federal Office at the Federal Institute for Risk Assessment (BfR) and was technically responsible for the accredited laboratories of the BfR including the NRLs located there. She has extensive experience from industry, the public sector, research, universities and institutions in Germany and abroad (Germany, Singapore, China). Since August 2022, Dr Hunke has been working as GLP-QA and as a consultant at DiQualis Germany with expertise in ISO and regulatory GxP requirements as well as laboratory-related computerised systems (LIMS, eSignature, ELN, eDMS).
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Program Director Artificial Intelligence Engineering Department of Computer Science Dr Knapp studied bioinformatics in Hagenberg and Heidelberg. He obtained his PhD and Habilitation in biomedical computer simulations from the Medical University of Vienna. After his Habilitation he did a research fellowship at the University of Oxford (Department of Statistics and Computer Science) where he also became Associate Director of a Doctoral Training Centre. After four years in the UK he moved as Associate Professor to the UIC Barcelona where he spent another three years leading a research group before returning to Austria into an industry position at the biotech company Symptoma.com in Vienna. As chief data scientist he managed a team of data scientists and analysts in symptoms-to-disease predictions. In August 2021 Bernhard Knapp joined the University of Applied Sciences Technikum Wien as Program Director of the master in "Artificial Intelligence Engineering". His fields of research include machine learning algorithms, AI applications, immuno/bio-informatics, data analysis, and molecular simulations. In these fields he published 49 scientific journal papers.

Hans de Raad is an independent ICT architect and senior regulatory compliance consultant with a focus on security/privacy related technical and compliance issues between "business" and ICT. Through his company OpenNovations he has in-depth experience with soft-, and hardware development (SaMD), security assessments and pentesting, training/consultancy and project management from government agencies, enterprise through SME to internet startups.

Head of Quality Assurance After studying pharmacy, obtaining his licence to practise medicine and completing his doctorate, Ronald Schmidt joined Sanofi-Aventis Deutschland GmbH in 2006 as Principal Investigator for bioanalytical phases of GLP and GcLP studies (validation of various software products and development of new electronic workflows). In addition, he writes his own software, which is used in the regulated area of Sanofi-Aventis Deutschland GmbH. In 2015, R. Schmidt moved to Quality Assurance and has been Head of GLP Quality Assurance since 2017. Since 2019, he has headed the IT working group of the GQMA (German Quality Management Association).