The latest meeting of the Management Board of the European Medicines Agency (EMA) highlights the latest developments in the key regulatory activities of the agency.
A key focus of the meeting was the development of the Clinical Trial Information System (CTIS). It was noted that many milestones in the development of the system have already been achieved such as the initiation of independent auditing, the completion of phase one and preparation for phase two. Despite this, the go-live date has been revised and pushed back from December 2021 to 31 January 2022. Given the crucial role CTIS plays in the implementation of the new Clinical Trial Regulation, the board highlights the importance of ensuring all stakeholders are engaged in the extensive and ongoing CTIS training programme to maximise the benefits of the system.
A report from the Big Data Steering Group (BDSG) was another key highlight of the meeting. Given that a crucial element of the EMA’s Network Strategy to 2025 is to implement more data-based strategies in regulatory activities, the BDSG report outlines the progress made in this field in 2020 and in turn the work done towards fulfilling the long-term strategy.
Other highlights include updates on the ongoing assessment activities for Covid-19 vaccines and treatments and a revision of the EMA’s anti-fraud strategy.
To read the meeting highlights in full, click here.