|
1000
|
Abstract/Summary
|
-
This article summarises a presentation from 18 April 2024 at the 40th Annual Congres from the DGPharMed as the outcome of an experience report about two years practice under the European Clinical Trials Regulation 536/2014 (EU CTR) and with the Clinical Trials Information System (CTIS) with the perspective of the Sponsor Bayer AG and of the Clinical Research Organization (CRO) ICON. The approval timeline metrics and the most current information regarding the new transparency rules in CTIS and timelines for transition studies for clinical trials (CTs) which started under the EU Clinical Trials Directive (EU CTD) and transitioned to the EU CTR were presented.
|
