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Medical Devices in Medicinal Product Clinical Trials
Session Chair(s)
Tim Chesworth
Senior Director Regulatory Affairs
AstraZeneca, United Kingdom
Use of Medical Devices (both hardware and software) are becoming an increasingly prominent feature of medicinal product clinical trials. These are exciting opportunities to develop innovative therapies efficiently and safely to enhance patient outcomes. Progressing these opportunities raises a number of regulatory challenges as these combined studies bring together requirements in the CTR and MDR, in addition to those of individual Member States. This session aims to provide insight into these challenges and provide an opportunity to identify ways forward to address them.
Speaker(s)
Ilona Reischl, PhD, MPharm
Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Biologics Quality Assessor
Olga Tkachenko, PhD
European Commission, Belgium
Policy Officer
Isabelle Clamou
European Commission, Belgium
Policy Officer, DG SANTE Unit D2
Ruth Foster
Merck, Sharp and Dohme , Belgium
Director, Medical Devices, EU
Stiina Aarum
European Medicines Agency, United Kingdom
Scientific Administrator, Orphan Medicinal Products
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