Chris Bamford has a PhD in molecular oncology and over 20 years of experience working in clinical trial regulatory affairs. He has represented the IQVIA Regulatory Affairs team in EMA Stakeholder groups relating to the development of the EU Clinical Trial Information System (CTIS) since 2014, contributing from the perspective of both Sponsors and CROs as a representative of the Association of CROs. This has enabled him to support pharmaceutical companies and clinical trial sites in developing processes and adapting roles and responsibilities in relation to the new Regulation. To date IQVIA has submitted over 80 new clinical trial applications via the CTIS, and Chris will therefore be able to share thoughts on the experiences during the development of the EMA system from 2014-2023 and incorporate the perspectives of Sponsors, sites and the impact on authorities and ethics committees, framing the situation we find ourselves in today.