ICH Harmonised Guideline (GCP) E6(R3) – Jan. 24, 2024

Session Description

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This event is part of the Research Connect webinars hosted by the Hamilton Health Sciences.

The launch of the 2024 webinar series with a focus on “ICH HARMONISED GUIDELINE (GCP) E6(R3) New Data Governance Insights for Clinical Trials”. Lisbeth Bregnhøj, an expert DKMA & EMA Inspector, will be joining the event and helping us dive into the renovation (R3) of the ICH E6 (GCP) guideline with a focus on the expectations related to data governance. The draft R3 contains a new chapter on data governance and substantial changes are planned in the sections on sponsor and investigator responsibilities. Lisbeth’s presentation will contain an update of the most significant changes.

Lisbeth Bregnhøj, MSc Pharmacy, PhD. Medicines Inspector, GCP-Danish Medicines Agency, Medicines Control & Inspection. Lisbeth has been a GCP inspector at the Danish Medicines Agency (DKMA) since 2006, performing numerous national and international GCP and GVP inspections, on behalf of the DKMA and EMA in various settings such as sponsor sites, CRO/vendor sites and investigator sites. She has previously worked as a clinical trial assessor and as a regulatory affairs project lead. She has experience from a research and clinical practice perspective from working in a clinical pharmacology unit at a University Hospital in Copenhagen and has also worked as an auditor in the medical industry. 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 computerized systems and electronic data in clinical trials and is EC topic lead on the ICH E6 (R3).

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