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)? This information day provides a platform for discussion about the status of the implementation and further compliance with the new Regulation, as well as the associated legislation in the region.

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Session 5: Update on ICH Guidelines EU portal and database

Session Chair(s)

Mihaela David

Director Regulatory Affairs, PSI Pharma Support Romania SRL, Romania

Update on the CT Information System (CTIS) formally “EU Portal and Database” Overview of EU Regulation Related Guidelines

Speaker(s)

Overview and update on the CT Information System

Camelia Mihaescu

GCP, GLP and PhV Inspections, European Medicines Agency, Netherlands

Overview of EU Regulation Related Guidelines

Steffen Thirstrup, MD

Chief Medical Officer, European Medicines Agency, Netherlands