Lisbeth Bregnhøj

MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP, Danish Health and Medicines Authority

Lisbeth has been a GCP and pharmacovigilance inspector at the Danish Health and Medicines Authority

since 2006. Prior to that, she has experience from the authority perspective on regulatory affairs and as an assessor of clinical trial protocols (1993-1999), from a research and hospital perspective (Clinical pharmacology at a University Hospital in Denmark 1999-2005) and from working in the medicinal industry (GCP auditor 2005-2006).

Lisbeth has for the last 14 years performed numerous GCP and GVP inspections, both national inspections on behalf of the Danish Medicines Authority and international inspections on behalf of the European Medicines Agency in various settings such as sponsor sites, QPPV sites, CRO/vendor sites and investigator sites.

Lisbeth is part of the GCP Inspectors Working Group and of the sub group who authored the European GCP Reflection paper (and the upcoming guidance) on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.