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Work programme 2017

WC500221614

Human resources (FTEs)

Human resources (FTEs) 14 2017 3.5. Information management Activity area Information-management activities aim to establish and manage information as a key asset to support sound decisions and provide reliable information on medicines for the promotion and protection of human and animal health in compliance with European pharmaceutical legislation. This involves the delivery and operation of efficient and effective data and information-management services and increasing the Agency's information-processing capacity. The main activity areas in this domain include the following: • Information services to support the work of the network and the Agency, and to provide data and information to the public. Information services involve the management of data and information in a disciplined and coordinated manner to optimise the value of investments in data/information assets, support effective and efficient operations, mitigate legal and regulatory risks, and improve the delivery of services to stakeholders. Activities cover the entire information lifecycle from data creation to data processing, information dissemination and archiving. Information services rely on the integrated management of information (content) and the delivery and maintenance of information technology. • Data analytics on information services involves the discovery and communication of meaningful patterns for the purpose of describing and predicting the efficacy and safety of medicines, as well as for regulatory activities and operational performance. This activity covers statistical data analysis, data warehousing and business intelligence. • EU Telematics aims to put in place and maintain common, effective information-technology services that add value and optimise support to the network in the evaluation and supervision of medicines. It is a joint endeavour of the European Commission, the EMA and medicines regulatory authorities in Member States. This activity covers the support and coordination of the Telematics governance and the delivery and maintenance of shared data, IT systems and infrastructure. The EMA currently delivers and maintains 23 EU Telematics services: − − − − − − − − EU electronic application form (eAF), eSubmission portal, Common Repository for Centrally Authorised Products for electronic regulatory submissions, and PSUR repository to facilitate the exchange of information on the safety of authorised medicines; SIAMED dashboard (centrally maintained procedure management tracking database); Eudra Common Directory (ECD), EU Controlled Terminology (EUTCT), EudraPharm for Human medicinal products, EudraPharm for veterinary medicinal products), Art 57 database (product database of EudraVigilance system) for storing master data; EudraCT for clinical trials; EudraVigilance systems for human and veterinary medicines, Medical Literature Monitoring services for collection of adverse drug reactions; the EudraVigilance and clinical trials data warehouses for analysis; EudraGMDP for the management of GMP inspections in the EU; EudraLink (secure file sharing) and EudraMail (e-mail services) for collaboration; Work programme 2017 EMA/583016/2016 Page 96/123

− EudraNet (secure network for the EU regulatory network) and submission gateway (for transmission of submissions and adverse drug reactions) infrastructure components; − Referential Management Service and Organisations Management Service. The portfolio will be further expanded in the future with the delivery of projects such as the EU portal and database for clinical trials as well as the Product and Substance Management Services for human and veterinary medicines. Drivers Increasingly, digital technologies are becoming key enablers for the regulation of medicines. The EU, for example, requires centralised information technology for pharmacovigilance and clinical trials. Further demands are expected from the upcoming revision of EU legislation on veterinary medicines. Generally, there is a growing need for establishing interconnected information systems to manage and share information on medicines among regulators within the EU and globally. This relies on unequivocal identification of medicinal products according to international standards enforced by EU law. To fulfil its role, the EMA provides information and information systems to numerous partners and stakeholder groups with growing and different needs and demands. For instance, the work of EU medicines agencies and the Commission requires new or extended information-technology services; individually, EU agencies operate differently, which needs to be taken into account when implementing the EU Telematics strategy; the EU network of experts needs the right information at the right time and solutions that facilitate their work; the pharmaceutical industry is facing rising costs of regulation and expects information systems that help them meet their regulatory requirements more efficiently; cost-efficiency is particularly important for promoting the availability of veterinary medicines; patients and healthcare professionals demand timely access to information on medicines so they can make their own decisions. Globalisation of medicines requires that we share more information with regulatory authorities worldwide; academic sponsors also rely on EMA's information services, and this information is also important to further academic research. Therefore, the need to cater for a wide range of needs has an impact on how the EMA's information services are designed and provided. The ever-increasing role of information technology in health-related matters, including growing use of e-health records and databases, mobile communication and social media by consumers and healthcare professionals, demands that surveillance and analytics methods evolve accordingly. New approaches to allow timely access to novel medicines will rely on real-time post-authorisation monitoring and datadriven decision-making based on patient outcomes. Methods to gain insights from data and information technology are progressing at an exponential pace. A robust and agile information-technology infrastructure, partnered with new capabilities to manage data, is required to allow the Agency to reap the benefits of this growing presence and role of technology. To date, EMA has developed, hosted and curated its information-management estate on an infrastructure owned by EMA in London. In the context of the potential relocation of the Agency to another country, EMA will consider moving towards the use of cloud services 4 , following a robust impact assessment shared with the Management Board. Taking due account of the necessity for data protection and information security, this could mean outsourcing some services and activities to external suppliers, and could include data centre operations, hosting and maintenance of systems and data, etc. 4 Cloud services in this context are defined as IT services provided to multiple customers, over the internet, on a pay-asyou-go basis. This includes, for example, private, public or hybrid cloud, as well as Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS). Work programme 2017 EMA/583016/2016 Page 97/123

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