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.

Agenda

Day 1 Oct 22, 2019

8:00 AM — 8:15 AM

REGISTRATION

8:15 AM — 8:45 AM

Welcome Note

8:45 AM — 9:30 AM

Session 1: Clinical Trials Regulation Overview, Objectives and why the Replacement of EU Directive is needed

9:30 AM — 10:30 AM

Session 2: Industry Preparedness and View: Panel Discussion

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:30 PM

Session 3: Procedure for Initial Authorization and Substantial Modifications

12:30 PM — 1:30 PM

LUNCH BREAK

1:30 PM — 2:30 PM

Session 4: Implementation and Readiness Status at the Local Level Member States and Ethic Committees

3:00 PM — 3:30 PM

COFFEE BREAK

3:00 PM — 5:00 PM

Session 5: Update on ICH Guidelines EU portal and database

5:15 PM — 7:00 PM

Networking Reception

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Clinical Trial Regulation Information Day for CEE Countries

Agenda

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