戻る Agenda
In Vitro Diagnostic Regulation (IVDR) In The Context of Clinical Trials and Upcoming Clinical Trial Regulation (CTR)
Session Chair(s)
Claudia Dollins, PhD, RAC
Vice President, Precision Medicines, Global Regulatory Affairs
GlaxoSmithKline, United States
A major challenge to personalised medicine development is the complexity of clinical trial conduct. Acceptability to regulators and ethics committees of (complex) clinical trial designs with small patient populations are key. The session will give the opportunity to discuss with key stakeholders the future of clinical development of personalised medicine under the in vitro diagnostic Regulation.
Speaker(s)
Panelist
Ilona Reischl, PhD, MPharm
Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Biologics Quality Assessor
Panelist
Edit Szepessy
European Commission - DG SANTE, Belgium
Policy Officer
Panelist
Rolf Thermann
TÜV Rheinland, Germany
Section Manager IVD, Companion Diagnostics lead
Panelist
Sven Hoffmann
TÜV Rheinland, Germany
Panelist
Kirsty Macleod
QIAGEN Ltd, United Kingdom
Associate Director, Clinical Affairs