Lisbeth Bregnhøj

MSc Pharmacy, PhD., Medicines Inspector, GCP and PhV
Danish Medicines Agency, Control & Security of Supply

Lisbeth Bregnhøj 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 authorization 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 performed numerous GCP (and PhV) inspections, both national inspections on behalf of the Danish Health and Medicines Authority and international inspections on behalf of the European Medicines Agency in various settings such as sponsor sites, CRO sites and investigator sites.

Lisbeth is part of the EU GCP Inspectors Working Group and of the sub group who drafted the EU Guideline on computerised systems and electronic data in clinical trials. In addition, she is one of the two EU member state representatives on the ICH E6 R3 revision.

Lisbeth Bregnhøj taler på konferencen Kliniske forsøg - Insight Food & Health
Taler information
  • Jobtitel
    Lægemiddelinspektør, GCP. kontrol & forsyningssikkerhed
  • Firma
    Lægemiddelstyrelsen
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