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Novotel Bucharest City Centre

Oct 22, 2019 8:00 AM - Oct 22, 2019 7:00 PM

Calea Victoriei 37B Sector 1, Bucharest, Romania, 010061

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.

Back to Agenda

Session 5: Update on ICH Guidelines EU portal and database

Session Chair(s)

Mihaela David

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)

Camelia Mihaescu

Overview and update on the CT Information System

Camelia Mihaescu

European Medicines Agency, Netherlands

GCP, GLP and PhV Inspections

Steffen Thirstrup, MD, PhD

Overview of EU Regulation Related Guidelines

Steffen Thirstrup, MD, PhD

European Medicines Agency, Netherlands

Chief Medical Officer

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