Title of Presentation
“Clinical trial requirements for medicinal products and medical devices – When does your project fall under these legal requirements?”
Date and Place
Ilona Reischl joined the Austrian Medicines and Medical Devices Agency AGES/MEA in March 2006 and is head of the clinical trials department, which is responsible for clinical trials with medicinal products, clinical investigations with medical devices and GCP inspections.
Her regulatory focus is thus on all procedures in early development, while her scientific expertise is the quality assessment of biological medicinal products including Advanced Therapy Medicinal products.
She is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies.
Starting in academic research in immunology she transitioned to the regulation of medicines at the US Food and Drug Administration (FDA) assessing the quality of biological investigational new drug applications and conducting research on T cell signalling.
Her initial training comprises a degree in pharmacy, a PhD in immunology/allergology and postdoctoral experience at an industrial research institute, the University of Southampton (UK) and the National Institutes of Health (USA).
What are the legal definitions and requirements for medicinal products and medical devices to be on the market and when is your undertaking considered as a clinical trial and reportable to the National agency? The presentation will aim at answering these questions and further illustrate specific issues pertaining to projects investigating medicinal products and medical devices in parallel (combination trials). An outlook on the requirements of the Clinical trials Regulation for medicinal products and the Regulation for Medical devices and IVDs (as relevant to clinical trials) will be provided.