Stakeholder participation in information management

The European Medicines Agency (EMA) provides information for stakeholders such as national competent authorities and pharmaceutical industry associations on how they can participate in the Agency's Agile way of working and governance.

Governance of the Network Portfolio

EMA has put in place a bespoke Agile governance model to ensure balanced and effective representation of EMA’s key partners and stakeholders. Its governance bodies, listed below, actively participate in regular ceremonies, which define the Agile way of working.

Portfolio Board

This board is the main prioritisation body. It owns the Network Portfolio roadmap and backlog.

Network Portfolio Advisory Group 

This advisory group represents the Management Board and Heads of Medicines Agencies (HMA) within IT portfolio management. 

It attends relevant ceremonies jointly with the Portfolio Board, ensures oversight of progress and provides input on strategic decisions. 

Architecture Board

This board formulates the Agile governance's longer-term IT vision and policy. 

It provides the architecture framework that value streams need to develop new technology . 

It also ensures that data architecture standards are maintained, and reviews and endorses architecture and technology proposals. 

Network ICT Advisory Committee

This advisory committee provides insight on technical issues and technology, and interoperability considerations of the European medicines regulatory network. 

It represents the IT directors and experts communities from national competent authorities and the European Commission.

More details on the Agile portfolio governance structure are available in the documents below:

EMA Agile governance model

Network Portfolio Advisory Group (NPAG) - Terms of reference

Reference Number: EMA/535331/2021

Network Portfolio Advisory Group (NPAG) - Membership and role

Nominations to the Network Portfolio Advisory Group

Reference Number: EMA/593340/2021 Rev. 2

Network ICT Advisory Committee (NICTAC) - Updated Terms of reference

Reference Number: EMA/261670/2023

Network ICT Advisory Committee (NICTAC) - Membership and role

Network ICT Advisory Committee (NICTAC) - List of nominated members

Stakeholder participation in the execution of the Network Portfolio

The network participates in carrying out the Network Portfolio as part of Agile product teams.

Members of the network can take on the role of product owner and / or subject matter expert (SME) on product teams. They act as delegates representing and defending the interests of their respective communities, in accordance with Agile principles.

Network product owner

The network product owner is a member of the Agile team who represents the network.

It is responsible for collaborating closely with the product owner in developing a business solution or product of shared interest with the network.

The network nominates its product owner.

Subject matter experts

SMEs provide product teams with knowledge and expertise about a specific business solution or product.

They are temporary members of product teams and only stay in their roles as long as the teams need them.

The network or EMA's stakeholders (e.g. pharmaceutical industry representatives) can nominate SMEs at the request of product owners. 

EMA sends out the calls for nominations to national competent authorities and / or relevant stakeholder organisations (e.g. industry associations).

Stakeholders can also take the role of SMEs and get involved in portfolio execution.

SMEs can contribute at different levels to the development and implementation of a business solution or product, as shown in the table below:

Level	SME roles
Portfolio	Help define the minimum viable product Draft documents
Value stream	Participate and advise product teams in draft sessions for dedicated features (upon request)
Execution	Participate in development activities, when guidance is requested Collaborate with the business analyst to formulate related requirements that support the development of features Support user acceptance testing
Agile ceremonies	Participate in programme planning upon request of product owner and when expert insight is required Support feature estimations and mappings

 

For more information on Agile ceremonies, see:

• Network Portfolio - Agile way of working

More details on the selection process and ways of working of SMEs are available in the following documents:

Network product owner and subject matter experts in EMA Agile way-of-working - Terms of Reference (ToR)

Reference Number: EMA/198482/2022

Confidentiality undertaking for network product owner and subject matter experts (SMEs) in European Medicines Agency’s agile way-of-working

Reference Number: EMA/250671/2022

Guidance on the interpretation of document - Confidentiality undertaking for network product owner and subject matter experts (SMEs) in European Medicines Agency’s agile way-of-working (EMA/250671/2022)

Reference Number: EMA/28183/2023

To consult the list of active industry SMEs in product teams and planned calls for nominees for industry SMEs, see:

List of industry subject matter experts and list of planned calls for industry subject matter experts

European Medicines Agency’s data protection notice for publication of contact details of industry representatives in Agile teams

Reference Number: EMA/282298/2023