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Session 1: Joint Session - Overview of the CTIS
Session Chair(s)
Rose-Marie Swallow
Senior Manager, Policy & Research
Bayer Plc., United Kingdom
Matthias Zerm, PhD
Lead Expert, Clinical Trial Disclosure and R&D Processes
Merz Therapeutics GmbH, Germany
Overview of CTIS as it is about to undergo audit to confirm that it is ready for CTR implementation. This session will demonstrate the functionality of CTIS for Sponsors and Regulators. This is an opportunity for EMA to showcase the CTIS and how far its development has progressed as it stands on the brink of being audited and found to be ready for implementation.
Speaker(s)
CTIS – a system ready for audit and implementation of the CTR
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
CTIS – a system ready for audit and implementation of the CTR – a Sponsor view
Christopher Price, MA
Merck Healthcare, Germany
Senior Manager, Global Regulatory Oncology, Global Regulatory Affairs