studied medicine and specialised in pharmaceutical medicine. For almost 20 years, he has focused on global drug safety and the development of pharmacovigilance (PV) systems. As an EU QPPV and step-by-step plan officer, he oversaw compliance for multinational trials and post-marketing portfolios – ranging from orphan drugs to biosimilars. He has in-depth expertise in regulatory inspections and audit management. He is now taking on the role of a designated officer under the German Medicines Act (AMG) at TentaConsult and advises pharmaceutical companies on all GxP matters.