Round table
Thursday 09:00 - 10:30
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MAIN HALL (HYBRID)
“CLINICAL DATA FOR SAFETY AND PERFORMANCE OF MEDICAL DEVICES (MD) TO OBTAIN MARKET AUTHORIZATION APPROVAL”
Chair:
Ghazaleh Gouya, Priv. Doz Dr. med Cardiologist, Founder of Gouya insights, GPMed Board Member & IFAPP Board Member
Speakers:
‘Design of clinical MD investigations and approvable endpoints’
Andreas Beust, Dr, Chief Scientific Officer, GCP-Service International Ltd. & Co. KG
‘How much clinical data from Medical Device studies is enough for CE mark?’
Shayesteh Fürst-Ladani, MBA, MSc, GFMD, Senior Vice President SFL, Head of SFL Group
‘Guidance documents’
Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, School of Medicine, Trinity College Dublin
Speakers

Priv. Doz. Dr med, Cardiologist, Founder of Gouya Insights, GPMed Board Member and IFAPP Board Member
«Chair»

Associate Professor of Medical Device Regulatory Affairs, Trinity College Dublin
«Speaker»