ACDM26 Speakers

Lisbeth Bregnhøj

Medicines Inspector, GCP at Danish Medicines Agency

Lisbeth has been a GCP/PhV inspector at the Danish Medicines Agency since 2006. Prior to that, she has regulatory experience from working as a clinical trial assessor, and in assessing approval of marketing authorisations. She also has experience from a research and hospital perspective from working with clinical pharmacology at a University Hospital in Denmark and experience as an auditor in the medical industry.
Lisbeth has for the last 20+ years performed numerous national and international GCP and GVP inspections, on behalf of the Danish Medicines Agency and the European Medicines Agency in various settings such as sponsor sites, CRO/vendor sites and investigator sites.
Lisbeth is part of the GCP Inspectors Working Group and of the e-sub group and has chaired the drafting of the EU guideline on computerised systems and electronic data in clinical trials. She is also part of the ICH E6 revision 3 Expert Working Group and the ACT EU group 4 on GCP renovation.