LS&R 1648

EMA Management Board: highlights of October 2018 meeting

The Board was updated on the quality and status of the ongoing development of the EU clinical trial portal and database, both of which are being carefully monitored. The Board heard that the development of the auditable release of the portal and database (release 0.7) is complete. The release is now in an intensive phase of pre-testing before formal user acceptance testing (UAT7) can start in early 2019. Taking into account the rate of progress with testing and bug fixing, and the relocation of the Agency, the audit field work will take place once the Agency has settled in Amsterdam, after March 2019. Dependent on successful completion of the audit and review by the Management Board around the end of 2019, the system could be ready to go live later in 2020. Press release