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Medical Devices in Clinical Trials
Session Chair(s)
Isabelle Clamou
Policy Officer, DG SANTE Unit D2
European Commission, Belgium
Olga Tkachenko, PhD
Policy Officer
European Commission, Belgium
This session will present the COMBINE project on the interface between the EU regulations on clinical trials, in vitro diagnostics and medical devices. Combined studies can be understood as studies that involve the simultaneous investigation of a medicinal product, an IVD and/or medical device. The COMBINE project aims to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and to identify possible solutions to these challenges. The project involves representatives of competent authorities, the European Commission, medical research ethics committees, the European Medicines Agency, and relevant stakeholders from both the medicinal product and the medical device sectors. This is a first of kind collaboration across the clinical trials and medical devices sectors looking into the challenges faced by sponsors and authorities in the assessment and authorisation of combined studies.
Speaker(s)
COMBINE Project: Background and Scope
Olga Tkachenko, PhD
European Commission, Belgium
Policy Officer
COMBINE Project : Issue list (1)
Lucia D'Apote, DrSc, RAC
Amgen, Switzerland
Executive Director Global Regulatory and R&D Policy (ELMAC and JAPAC)
![Jana Russo](/_Images/member/Generic_Image_Missing-Profile.jpg)
COMBINE Project: Issue list (2)
Jana Russo
MedTech Europe, Belgium
Manager Medical Devices
![Gearoid O'Connor, MD, MSc](/_Images/member/Generic_Image_Missing-Profile.jpg)
COMBINE Project: Mapping of the EU landscape
Gearoid O'Connor, MD, MSc
HPRA, Ireland
Medical Officer, Medical Devices
COMBINE Project: Proposals for Solutions and Next Steps
Ditte Zerlang Andersen, PhD, MSc
Danish Medicines Agency (DKMA), Denmark
Senior EU Project Lead
![Marianne Carson](/_Images/member/Generic_Image_Missing-Profile.jpg)
Panelist
Marianne Carson
University of Oslo (UiO), Norway
Senior Advisor
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