In 1995 Elke began her career in clinical research and initially specialized in medical devices. Working in the Clinical Research Organization environment and subsequently in industry, Elke held positions including monitoring, project- and quality-management. Elke has established standard operation procedure processes, has set-up monitoring groups and subsequently led them. As a Quality Assurance Specialist she became an industry representative to EUCOMED and was actively involved in 2009 in the review of ISO 14155. After joining Gr√ľnenthal, 6 years ago, Elke has supported drug development teams in quality related activities; including audit and inspection preparation, conduct and CAPA processes, as well as review of validation processes and process documentation of GCP IT systems.