On June 6-7th, 2018, the European Medicines Agency (EMA) held the 100th meeting of its Management Board. Former chairs of the Board, plus all former Executive Directors of the Agency came to EMA to mark the occasion.
At the meeting, the Board was informed that EMA and the Netherlands have signed the Seat Agreement which describes the relationship among the Dutch Government and the Agency, its bodies and its employees once they start operating in the Netherlands.
The Board has assessed the Executive Director’s annual activity report for 2017. Areas of work highlighted by the Board include the Agency’s new framework and action plan for academia, the launch of the new EudraVigilance system and the first anniversary of PRIME (PRIority MEdicines), EMA’s initiative to enhance support to medicines that target unmet medical needs.
The Board also highlighted the Agency’s first public hearing in September 2017 where EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) invited patients, doctors and other stakeholders to share their experience with valproate and thus contribute to the safety review of this medicine. During the meeting, the Board heard about lessons learned from the public hearing, just one week ahead of the second public hearing on quinolones and fluoroquinolones which will take place on 13 June 2018.
The annual activity report describes the management and control systems in place at the Agency. Every year it is submitted to the Management Board that assesses whether the Agency has carried out its activities in accordance with the principles of good governance.
The Board was updated on the quality and progress of the ongoing development of the EU Clinical Trial and Portal and Database, both of which are being carefully monitored. The Board heard that development of the auditable release of the portal and database (release 0.7) is nearing completion. The release is now in an intensive phase of testing. Where needed, the development resource is being adjusted to ensure quality and progress are maintained in line with the project plan. The Board noted that as details of the Agency’s relocation plans are being finalised, some further adjustments to the project planning may be required. The User Acceptance Testing (UAT) of release 0.7 is planned for November 2018 to allow for completion of the relocation of the development data centre, before UAT commences.
The Clinical Trial system continues to be prioritised in the context of the Agency’s relocation business continuity planning.