Lisbeth Bregnhoj
Danish Medicines Agency (DKMA), Denmark
Medicines Inspector, GCP
Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth has performed numerous GCP and GVP inspections for the last 18+ years on behalf of the Danish Medicines Agency and the European Medicines Agency in various settings such as sponsor sites, QPPV sites, CRO/vendor sites and investigator sites. She is part of the GCP IWG and the e-sub group who has authored the EU Guideline on computerised systems and electronic data in clinical trials. She is also part of the EWG currently drafting ICH E6 R3