Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth has performed numerous GCP and GVP inspections for the last 18+ years on behalf of the Danish Medicines Agency and the European Medicines Agency in various settings such as sponsor sites, QPPV sites, CRO/vendor sites and investigator sites. She is part of the GCP IWG and the e-sub group who has authored the EU Guideline on computerised systems and electronic data in clinical trials. She is also part of the EWG currently drafting ICH E6 R3

Susanne Nørskov is a pharmacist with 30 years of experience within the industry at a global level. Her interest includes drug development focused on clinical research specifically within quality and compliance. Since 2019 she has been the deputy EFPIA topic lead on the ICH E6(R3) update. Currently, Susanne is holding a position as a scientific Vice President in the Global Clinical Compliance, R&D Quality in Novo Nordisk A/S. She is based in Copenhagen.

Gabriele Schwarz, a registered pharmacist, joined the Federal Institute for Drugs and Medical Devices (BfArM) in 2001. She is currently BfArM’s GCP Strategy Expert and represents the EU in the ICH E6(R3) EWG, which is working on a revision of the GCP guideline. She is also contributing to a number of activities of the EMA ACT-EU project. Until the end of 2022, she was Head of BfArM’s GCP Inspectorate. In parallel, she has contributed to the development of a number of European guidelines e.g. for Risk-Based Quality Management, eSource, (e)TMF and Clinical Trials with Decentralised Elements, and also to international guidelines such as the OECD Recommendation on the Governance of Clinical Trials, the ICH E6(R2) and the ICH E19 Guideline.

Rebecca Stanbrook has worked in the pharmaceutical industry, as a regulator at the MHRA and at various pharmaceutical companies for over 30 years. Her main areas of interest are clinical trials and pharmacovigilance. She is a pharmacist by profession and holds a Diploma in Research Quality Assurance. Rebecca is thrilled to be a member of the ICH E6(R3) Expert Working Group. Currently Rebecca works as GCP Strategic Lead in Process & Risk Surveillance, in the Strategy, Portfolio and Programme Operations Group of Development in Novartis Pharma AG. She is based in Basel.