Lisbeth has been a GCP and pharmacovigilance inspector at the Danish Medicines Agency.Since 2006. Prior to that, she has experience from an authority perspective on regulatory affairs and authorisation of clinical trial protocols, from a research and hospital perspective (Clinical pharmacology at a University Hospital in Denmark) and from working in the medicinal industry as a GCP auditor. 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. She represents EU as the topic lead in the ICH E6 R3 revision.

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.