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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, 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)
Fergus Sweeney, PhD
Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands
CTIS – a system ready for audit and implementation of the CTR
Christopher Price, MA
Senior Manager, Global Regulatory Oncology, Global Regulatory Affairs, Merck Healthcare, Germany
CTIS – a system ready for audit and implementation of the CTR – a Sponsor view