Information Management and Digital Business Transformation

As with all public sector institutions, EMA needs to deliver a growing number of activities without a commensurate increase in staff. In this environment, the Agency is increasingly dependent on its ability to mobilise knowledge, technological skills and expertise and to improve the quality and speed of its own services. Digitalisation of interfaces, processes and services is a major tool in helping EMA to make best use of its limited resources.

Digital Innovation Lab

To accelerate digital transformation, EMA is building a Digital Innovation Lab (DigiLab) to discover, experiment and develop digital solutions that will support the core business and benefit the Agency, the network and other stakeholders.

In 2021, DigiLab designed a process to capture opportunities for digital innovation in order to prioritise the most promising ideas and business needs and turn them into potential solutions. Digital innovations that were initiated in 2021 included experimentation with virtual reality, such as a 360-degree interactive video aiming to deliver immersive training experiences.

DigiLab works closely with the Agency’s Analytics Centre of Excellence to explore how AI, machine learning and robotics can be used to build pragmatic solutions to existing EMA business needs with the main objective of gaining efficiency. Examples of successful pilots during 2021 include:

• application of AI to speed up core business processes, such as the validation of Type I and Type II variation applications to marketing authorisations;
• identification and redaction of personal data in documents;
• automation of the triage of incoming requests for information;
• a chatbot to help stakeholders find information on the EMA website faster. 

The deployment of these solutions has either started in 2021 or will start in 2022.

Information management at EMA

A major review of EMA’s information management governance model (including the governance structure formerly known as EU Telematics) was carried out from end-2020 until end-Q1 2021. The review included interviews with key EMA internal as well as external stakeholders, both NCAs and industry. The review concluded that improvements could be made to a number of points: increase transparency on decision making and priority setting; simplify the existing structure and number of governance bodies; and clear allocation of ownership of outcomes. This led to a recommendation from the Executive Board and EMA’s Management Board to change the model. In June 2021, they endorsed the adoption of an agile way of working and the implementation of agile governance principles across all layers of technology delivery (strategic, portfolio, execution) by adopting the Scaled Agile Framework (SAFe). 

Across industry, Agile and SAFe are broadly considered as best practice, with benefits ranging from a faster delivery of technology, increased transparency, better alignment between business and IT and easier management of changing priorities. For EMA specifically, it is expected to deliver:

• a holistic portfolio management with a strong business value focus and quick and incremental delivery of IT systems that focus on improving end-user satisfaction and unlocking data; 
• a reduction in steering committees and project boards, and thus reduced administrative burden and clearer accountability;
• increased transparency on how and why decisions are made and on the progress of implementation and their outcomes. 

In July 2021, the old EU Telematics governance bodies were dissolved, and a pilot to test the new way of working was launched in September 2021. EMA established two new governance bodies in autumn 2021: the Network Portfolio Advisory Group (NPAG), comprised of HMA and Management Board members, and the Network ICT Advisory Committee, which includes four IT Directors and experts from the NCAs and a representative from the European Commission. EMA is currently operating a hybrid system, in which the new agile governance model and way of working is being rolled out progressively across the full portfolio of IT projects.