Birthe has a background as MSc. in Pharmacy and has worked in the pharmaceutical industry for more than 25 years. She started her carrier as a research scientist working with development and validation of bio-analytical assays, but moved into the clinical research area in 1992, where she has worked with small and mid-size Biotech and Pharma companies. Birthe has been employed as Principal Quality Specialist with LEO-Pharma since 2010, and is based in Copenhagen. Since 1994 Birthe has been working as an auditor in the GCP, GLP, IT and Pharmacovigilance area and has in addition hosted local as well as FDA, MHRA and PMDA Inspections. Birthe is currently a board member in the Danish Quality Group, DKG and has been active in the group, since she joined the Quality Assurance work. In addition Birthe is member of the EF GCP Audit Working Party.