The European Medicines Agency (EMA) has published its management board highlights for October 2019.
The highlights include an update on Brexit, the adoption of a mid-year report 2019, information on EU IT systems required by the Clinical Trial Regulation and information on the ongoing access to documents cases.
On Brexit, the EMA reports that delivery of the EMA’s work programme for Q4 2019 will continue to be challenging, due to staff shortages arising from the move from London to Amsterdam and loss of UK staff engaged in interim remote-working.
In addition, the update also reports on potential organisational changes, stating:
In order to be best prepared to address future challenges with the existing workforce, Executive Director Guido Rasi announced that the Agency is reviewing its organisational structure and looking to set up task forces that will focus on areas that are also key priorities for the network such as digital business transformation, data analytics and methods, regulatory science and innovation, and clinical trials and manufacturing strategy.”
More from the management board highlights is available here.