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Work programme 2017

WC500221614

Programme / Legal basis

Programme / Legal basis Start End Deliverables 2017 Project date date Corporate website publish Article 57 database online n/a Q1 2014 2019 • Analyse feasibility of outsourced development, build and hosting of the corporate website Standalone projects Identity and access management 2 SIAMED systems integration phase I Publication of clinical data for medicinal products for human use Rationalising working parties n/a 2017 2017 • Analysis and design documentation for the on-boarding of selected applications • Configuration of the identity governance solution to integrate with the selected applications and roll-out in production • Communication and knowledge transfer material n/a 2017 2018 • Functional and non-functional specifications defined • System and business use cases developed • Data architecture defined • SIAMED architecture designed • Implementation plan • Change management and communication plan n/a 2014 2017 • Develop workflow and case management tool n/a Q1 2015 2017 • Redesign the architecture and governance • Revise the work plan development process • Revise the guidelines lifecycle process • Revise the rules of engagement with interested parties • Continue with operations harmonisation • Develop and roll out a communication plan Work programme 2017 EMA/583016/2016 Page 100/123

4. Support and governance activities Activity areas This area covers all the general functions and activities performed at the Agency that are necessary to ensure continuous operations of the Agency, but are not business-specific. These include the following: • Corporate governance. These activities cover management of the Agency and corporate planning, including support to the Management Board and senior management of the Agency. • Planning and monitoring. These activities encompass the corporate planning cycle, including the planning processes (strategy, annual work programmes, link to the budget) and the subsequent monitoring and reporting activities. • Finance. Finance refers to budget processes (planning, monitoring and reporting), maintenance of accounts, payment management and collection of revenue, as well as management of cash resources and ex ante verification of transactions. • Human resources. Human resources deal with all staff-related matters, including developing and maintaining HR strategy and policy, conducting recruitment and procurement, managing personnel administration and payments, running a trainee programme, managing staff declarations of interests, providing staff support and training, and dealing with staff complaints and appeals. • Information technology. IT provides and maintains required IT solutions to support the EMA's corporate activities and services of the network (i.e. Telematics systems). IT activities include design and delivery of IT solutions through the Agency's portfolio of programmes and projects, IT infrastructure services (including running two data centres), maintainability of IT services, internal and external user support, and IT security/risk-management. • Legal services. Legal activities refer to legal advice on matters such as pharmaceutical law, contracts and procurement, staff-related matters, data protection and corporate governance, as well as on anti-fraud issues. These also include dealing with complaints submitted to the European Ombudsman and representing the Agency before the European Court of Justice, General Court or Civil Service Tribunal. The EMA's legal service deals regularly with European Commission representatives on the Agency's core activities, and also provides advice and support, among other things, on the implementation of new legislation and legal scrutiny of scientific opinions. • Quality- and risk-management, and internal-control coordination. Quality-management includes both the integrated quality-management activities and risk-management within the Agency. Riskreview is conducted annually, with risks being assessed at a residual level, i.e. taking into account controls and mitigations already in place. Conducting self-assessments (as part of the EU Agencies benchmarking programme), annual reviews of sensitive functions and ex post controls also falls within this area, as does maintaining a register of exceptions. • Internal audit. Internal audit reviews and evaluates risk-management, governance and internalcontrol processes at the Agency, to provide to the Executive Director and the Management Board independent and objective assurance and consulting services designed to add value and improve the Agency's operations. • Infrastructure services. These cover activities related to the Agency's premises and office accommodation, security, business continuity, health and safety, environment management, reception and switchboard, mail management, reprographics and offsite archives, as well as catering. Work programme 2017 EMA/583016/2016 Page 101/123