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Novotel Bucharest City Centre
22 oct 2019 8:00 a.m. - 22 oct 2019 7:00 p.m.
Calea Victoriei 37B Sector 1, Bucharest, Romania, 010061
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.
8:00 AM — 8:15 AM
8:15 AM — 8:45 AM
9:30 AM — 10:30 AM
Session 2: Industry Preparedness and View: Panel Discussion10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 3: Procedure for Initial Authorization and Substantial Modifications12:30 PM — 1:30 PM
3:00 PM — 3:30 PM
3:00 PM — 5:00 PM
Session 5: Update on ICH Guidelines EU portal and database5:15 PM — 7:00 PM
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