Clinical Trial Regulation Information Day for CEE Countries

Agenda

Day 1 Sep 18, 2020

8:30 AM — 9:00 AM

Log-in and Connect

9:00 AM — 9:30 AM

Welcome and Keynote from the Polish Medical Research Agency

9:30 AM — 10:30 AM

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

10:30 AM — 11:00 AM

Coffee Break

11:00 AM — 11:45 AM

Session 2: Procedure for Initial Authorization and Substantial Modifications

11:45 AM — 1:00 PM

Session 3: Industry Preparedness and View - Panel Discussion

1:00 PM — 2:00 PM

Lunch Break

2:00 PM — 3:45 PM

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

3:45 PM — 4:15 PM

Coffee Break

4:15 PM — 5:30 PM

5:30 PM — 6:30 PM

Speed Networking

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