The Network Portfolio facilitates EMA's mission of promoting and protecting public and animal health in the European Union (EU), and includes both internal EMA systems and those used by the network and stakeholders.

EMA is responsible for developing and maintaining IT systems that enable, among others, the implementation of European pharmaceutical policy and legislation.

These services should be cost-effective, efficient and interoperable, helping to optimise support to the European medicines regulatory network in regulating medicines for the protection of human and animal health.

Network Portfolio work

The Network Portfolio is the collective term for all network systems and services either being developed or already in operational use by the network and its stakeholders.

Information on IT plans for the forthcoming period is available below in EMA's overall programming document (see point 8, Pillar III of the Network Portfolio).

EMA works with the network in the European medicines regulatory network to develop and maintain IT systems.

The Agency contacts any partners or stakeholders affected by its plans to ensure the successful adoption of new technology.

Agile transformation

EMA is phasing in an Agile way of working and governance model for IT systems and services, to better meet the needs of the European medicines regulatory network. 

The Agency's Management Board endorsed the Agile transformation in June 2021, following a review of EMA's previous governance and delivery model for its IT portfolio. 

EMA is implementing the Scaled Agile Framework (SAFe) governance, delivery and operations according to a five-year roadmap due to be completed in 2027.

The Agile transformation covers both the development of new IT systems and the maintenance of IT systems in production.

EMA’s Agile ambition is to shift from the previous model of rigidity to an agile approach of adaptability, to achieve the following benefits:  

  • Greater transparency on how decisions are made and their outcomes 
  • Clear ownership of decision-making 
  • Improved business and IT alignment 
  • Highly-focused portfolio-management practices 
  • Better communication within the European medicines regulatory network and with industry 
  • Greater focus on value

The Agile Transformation is supported by EMA's CIO Office, the Portfolio Management Office and the Lean Agile Centre for Excellence. More information on EMA structures is available in Who we are

Agile way of working

In line with the Scaled Agile Framework (SAFe), regular ceremonies govern the delivery of the Network Portfolio.

Each ceremony performs a specific function, and the participants are tailored to ensure the right representation and Agile implementation.

The ceremonies should enable the four core values of SAFe: 

  • Transparency
  • Alignment
  • Respect for people
  • Relentless improvement

The Strategic Portfolio Review is responsible for:

  • providing continuous strategic alignment;
  • looking at the horizon and checking for strategic alignment;
  • having a forward-looking focus;
  • collecting input on large internal and external influences that might change strategic direction.

It is the responsibility of the Strategic Portfolio Sync to:

  • review how the portfolio is progressing towards meeting strategic objectives;
  • include reviewing value stream performance at portfolio level;
  • focus on looking backwards.

The main goals of the System Demo are to:

  • provide an integrated view of new features delivered in a value stream; 
  • give stakeholders an objective measure of progress during a programme increment; 
  • receive stakeholder feedback on what is delivered;
  • being open to all stakeholders, including industry participants.

For more information on System Demo events:

The PI defines the overall release plan for epics in the forthcoming period (e.g. quarter) and identifies dependencies across teams.

Value streams

The Network Portfolio is organised in value streams. They should:

  • reflect the main goals and values of the Agency;
  • help create sub-portfolios that are independent and can support long-term strategic goals;
  • be stable and long-lived, with a fixed budget, leadership, resources, and capacity.

EMA has implemented five value streams, each one focused on a set of capabilities:

  • Research and development (R&D) - to support the development of new medicines and generation of scientific evidence.
  • Product lifecycle management - to manage the authorisation and lifecycle of medicines and certain medical devices.
  • Monitoring - to monitor the availability and safety of products.
  • Managing the Agency - to help manage EMA, and coordinate and support the European medicines regulatory network.
  • Technology lifecycle management and information security - to manage information technology and security.

Inclusion of EU Network and stakeholders

The network and stakeholders are part of the Agile product teams and attend Agile ceremonies. In this way, they participate directly in the delivery of the Network Portfolio.

More information on the network and the involvement of stakeholders in EMA’s Network Portfolio delivery is available:

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