Clinical Trial Regulation Conference

Join experts from regulatory, ethics bodies, sponsors and patients to discuss latest developments of Clinical Trial Regulation and ensure its successful launch.

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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)

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

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