RAPS: REC Webcast: EU Clinical Trial Regulation – Are You Ready?
The new EU Clinical Trials Regulation (CTR) was published in 2014, became applicable in all member states Jan 31 2022 and from Jan 31 2023 is mandatory for all new EU clinical trials (CTs). The EU CTR harmonises clinical trial applications in Europe and aims to deliver greater public transparency around CTs in Europe and create a favourable research environment in Europe by reducing administrative requirements on CTAs and streamlining workflows. The changes introduced in the CTR are broad, and require industry CT sponsors, CROs and Regulatory Agencies to approach CT applications differently, including submission via the new Clinical Trial Information System (CTIS). CTIS is a single online portal through which clinical trial sponsors and other organisations involved in running clinical trials will submit data related to a trial and post-trial results. The session will begin with a brief overview of the changes introduced in the Clinical Trials Regulation, followed by sharing of implementation experiences of Industry CT sponsors, CROs & Agencies. The audience will then have the opportunity to exchange experiences around implementation and use of the CTIS and pose questions to the speaker panel to ensure readiness for implementation in January.