Clinical Trials Workshop

This session aims to cover a lot of topics relating to the ongoing development of the CT Portal and database which includes obtaining an update from the EMA on the status and current development of the database aiming to provide Workshop attendees with an oversight of what to expect and when covering the EMA’s thinking on submission of CTAs, notifications and user registration. It includes the responses from key stakeholders including industry, non-commercial/academic sponsors and (if possible) a Member State, as well as the public availability of CT data including transparency in EU database and initiatives to facilitate public availability of results to include: • Overview of the EMA’s proposals for transparency of data from the EU database and a response from a stakeholder. • Outline of how to meet the requirements to provide end of study results (including clinical study reports and summaries). Perspective on whether the level of transparency from the CTReg will meet the public desire for information on Clinical Trials.