The Cancer Drug Development Forum (CDDF) will hold a live webinar on “EU Clinical Trial Regulations.” on 12 November at 17:00 CET. This webinar will feature two lectures given by Dr Tarec Christoffer El-Galaly (Aahrus University, DK) and Stéphanie Kromar (EORTC, BE) and will be followed by a panel discussion moderated by Prof. Ruth Plummer (CDDF) and Dr Catarina Edfjäll (CDDF).
WEBINAR OUTLINE
The EU CTR was introduced in January 2022 and aims to harmonise the procedures for assessment, approval and supervision of clinical trials throughout the EU. Following a one year transition period all studies are submitted under this new regulation. In this webinar two experts who have been closely involved during its implementation will discuss some of the challenges and benefits of the new procedure.
Professor Tarec El-Galaly (Aahrus University, DK), a consultant haematologist and chair of one of the Danish National Ethics Committees, will discuss how they have worked to implement the new system, exploring some of the challenges, benefits and also opportunities for use of novel trial designs under the new legislation to enable acceleration of drug development to patient benefit.
Stéphanie Kromar, head of Regulatory Affairs at the EORTC, will reflect on the CTR implementation process from an academic sponsors perspective and the practicalities of changes to the regulatory set up of studies across Europe.
Agenda: (CET time zone)
17:00 – 17:05 Introduction – Prof. Ruth Plummer (CDDF, UK)
17:05 – 17:20 Lecture by Dr Tarec Christoffer El-Galaly (Aahrus University, DK)
17:20 – 17:35 Lecture by Stéphanie Kromar (EORTC, BE)
17:35 – 18:00 Panel discussion – moderated by Prof. Ruth Plummer (CDDF, UK) and Dr Catarina Edfjäll (CDDF, SE)
Dr Tarec Christoffer El-Galaly
Dr. Tarec Christoffer El-Galaly is a consultant hematologist and professor of hematology at Aarhus University Hospital and Aarhus University. He holds additional professorships at Aalborg University and the University of Southern Denmark. His primary clinical focus is lymphoma, and he serves as the chair of the Danish Lymphoma Group and the guideline committee for diffuse large B-cell lymphoma.
Dr. El-Galaly’s main research interests include epidemiology and real-world data studies. He has published over 150 peer-reviewed papers in these areas. He also has a strong interest in clinical trials, clinical trial methodology, and regulatory aspects, drawing on his previous experience in the pharmaceutical industry where he worked in late-stage development, and from his tenure at the Danish Medicines Agency.
In addition to his research and clinical duties, Dr. El-Galaly is actively involved in ethics and regulatory committees. He is currently the chair of a national ethics committee and serves as the vice-chair of the Scientific Advice Group for Oncology at the European Medicines Agency.
Stéphanie Kromar
Stéphanie Kromar joined the European Organisation For Research And Treatment Of Cancer (EORTC) in 2013. Since September 2022, she is the Head of the Regulatory Affairs department. She has experience in the preparation, submission, and follow-up of Clinical Trials Applications from the development until the end of the trial, on complex trial designs and she provides regulatory advice. She has an in-depth knowledge of the CT Regulation, was involved in the CTIS project almost since the beginning and she also took part to the review of the CTIS training material.