The joint EU Telematics governance model

EU Telematics Management Board The EU Telematics Management Board provides the vision for, and strategic oversight of, the EU Telematics Programme and the roadmap for its implementation. Composition 3 HMA 3 EMA Management Board including EC 3 EMA IT Directors Executive for Telematics: 3 EMA (incl. CIO and IT managers) 3 NCA IT Directors 1 EMA IT Liaison Terms of Reference

IT Directors The IT Directors functions at the tactical level and has delegated decision making power to manage the EU Telematics portfolio in all its aspects within the strategic framework endorsed by the EU TMB. It oversees both project and operational activities. Composition IT Directors group All network IT Directors Chair: EMA CIO 1 EC DG SANCO EMA IT Liaison officer Terms of Reference The IT Directors Executive Committee executes the approved vision and strategy as decided upon by the EU TMB and the IT Directors and acts as kernel representation of the membership of the IT Directors group. The Executive Committee also forms part of EU TMB. Composition 3 EMA (incl. CIO and IT managers) 3 NCA IT Directors

Telematics Enterprise Architecture Board The Telematics Enterprise Architecture Board which operates on behalf of the European Medicines Regulatory Network, defines and approves the end-to-end architecture of EU Telematics. Comparing with the previous Telematics structure: This board is new to reinforce the decisions on projects at the IT Directors Composition EMA CIO (Chair) 3 EMA 4NCA 1 EC (ISA DIGIT) Terms of Reference

Projects & enance Projects and enance, where at the operational level the aim is to establish structures to assure joint project delivery and maintenance support in the most efficient manner possible Projects Individual project structures will be tailored, depending upon the project definition and scale of work, and will be based on the common template Projects will be resourced as necessary through their lifecycles Requirements gathering and consultation will be undertaken through ad-hoc groups established for the purpose in the context of the projects objectives enance enance structures focus on the delivery of appropriate service levels and the coordination of system changes and enhancements control Three Change Management Boards(CMBs) e-submissions, Human Medicines and Veterinary Medicines, will coordinate system changes, enhancements and other recurring activities Telematics Change Advisory Board (CAB) will act as the final production gateway examining each change (or release) and then approving it to be deployed Adherence to service levels will be monitored and followed up as necessary A release calendar will be established and maintained via close liaison between EMA and NCAs

Projects & enance All project structures are based on the common project structure template The IT Directors Executive Committee approves each project structure and acts as the IT Programme Board for Telematics Project may have a Steering Committee chaired by the Business Owner and an IT Director, ensuring direction and issue resolution Day-to-day project management is carried out by either an IT or business project manager, depending on the project The project team delivers the solution Advisory and/or consulting groups provide input on requirements and support implementation

Telematics Systems Life-cycle Projects & enance

Change Management Structure IT Directors Executive Committee esubmissions CMB esubmission Roadmap EMA, NCA & industry members Systems & guidelines Hum Medicines CMB Whole life cycle of medicines EMA, NCA & industry members Systems, data & guidelines Vet Medicines CMB Whole life cycle of medicines EMA, NCA & industry members Systems, data & guidelines CR management CR management CR management Syst 1 Syst 2 Syst 3 Syst 1 Syst 2 Syst 3 Syst 4 enance (EMA or NCA) Syst 1 Syst 2 Into production Telematics CAB Release calendar Operations and user support (EMA or NCA)

Support The Telematics governance is supported by: Telematics PMO assures centralized reporting and appropriate application of standards across the EU Telematics activities Telematics Secretariat provided by EMA provides organizational and administrative support acts as a central contact point

EU Network Data Board This governing body driven by the business ensures that data is appropriately managed for the Network and reports to the EU Telematics Management Board (EU TMB) The outline mandate Development of data management strategy Policy setting for the network on data: collection, management, access Assurance of coherent implementation of data management and underpinning IT systems International Standards: coordination of development and implementation, monitoring of adoption Interaction with industry Terms of Reference Composition 8 NCA members ( 2 small, 3 medium-size, 3 large countries) 6 EMA members 1 EC 1 EDQM

Contacts telematics secretariat@ema.europa.eu