Clinical Trial Regulation Information Day for CEE Countries

Are Central and Eastern European Union member states ready to implement the new EU Clinical Trial Regulation (536/2014)? Join the discussion on managing clinical trials in the face of changes coming soon in 2021.

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Session 5: Overview and Update on the Clinical Trial Information System (CTIS) in addition to the of EU Regulation Related Guidelines

Session Chair(s)

Mihaela David

Director Regulatory Affairs

PSI Pharma Support Romania SRL, Romania

Session 5: Overview and Update on the Clinical Trial Information System (CTIS) in addition to Overview of EU Regulation Related Guidelines

Speaker(s)

Overview and Update on the Clinical Trial Information System

Fia Westerholm, DVM, MSc

European Medicines Agency, Netherlands

Programme Assurance Manager

Overview of EU Regulation Related Guidelines

Steffen Thirstrup, MD, PhD