ACDM26 Speakers
ACDM26 brings together leading industry experts to deliver a diverse range of presentations, panel discussions, and breakout sessions. Speakers will share their extensive knowledge and experiences on a range topics, including practical AI, technology, innovation, RBQM, soft skills, different perspectives, USDM, eCOA, ICH E6, and more.
Meet the ACDM26 Speakers below.
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.
Association for Clinical Data Management Limited
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