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Work programme 2017

WC500221614

Workload indicators Information Management workload indicators are directly related to those for the various business processes and data-management activities described under the specific business activities in this work programme. Results Forecasts 2014 2015 2016 2017 Number of Telematics information services provided by EMA 16 20 22 23 Number of ongoing Telematics IT projects where EMA is the 19 18 13 8 delivery organisation Number of ongoing non-Telematics IT projects where EMA is the delivery organisation 15 11 6 6 Performance indicators Results Targets 2014 2015 2016 2017 Satisfaction of external customers of Telematics information services provided by EMA (% satisfied & very satisfied) Satisfaction of EMA internal customers of information services (% satisfied & very satisfied) n/a n/a 94% 80% n/a n/a 94% 80% Additional objectives and activities In order to deliver the IT solutions required by EU law, the Agency will continue implementing a number of projects, including on master data management services, enhanced EudraVigilance system for human medicines, European clinical trial system and others. More detailed information on these can be found under the project sections of the work programme. Medium-term objective MAWP initiative Activity description Timeframe Start End Share information on medicines within the network and with stakeholders Establish and improve EMA information services 3.2-12 Improve and establish systems and processes to ensure timely access to clinical data 3.2-12 Finalise implementation of the Enterprise Architecture function, including processes and artefacts Before 2017 2016 2016 2017 Resources Information management covers a wide range of Agency activities, hence resources are allocated to the relevant activities and chapters throughout this work programme. Work programme 2017 EMA/583016/2016 Page 98/123

3.6. Projects To support the Agency's work and achievement of its set objectives, a number of programmes and projects will be undertaken. The table below details the main projects, along with their timelines and deliverables that the Agency will pursue in 2017. The main projects in 2017 will relate to the following: • Data integration. This programme aims to deliver ISO-compliant systems for substance management, product management, organisations management and referential management, supported by appropriate standards and security framework which when integrated with core regulatory processes across Europe result in operational efficiencies and excellence in the evaluation and supervision of medicines. • Clinical data publication. This is a project to implement the Agency's policy on publication of clinical data for medicines for human use in accordance with the agreed stepwise approach, as part of wider transparency initiatives. Programme / Project Legal basis Start date End date Deliverables 2017 Data integration programme Referentials management service Organisations management services Substances and products management services (including veterinary Union database) • Regulation (EC) 520/2012, art.25 and 26 • Pharmacovigilance fees regulation 658/2014 • Regulation 726/2004, art.57(2) • Regulation (EC) 520/2012, art.25 and 26 • Draft veterinary regulation, art.51 • Clinical trials regulation 536/2014, art.8193) • Pharmacovigilance fees regulation 658/2014, art.7 • Art.4 of Guideline on e- prescriptions dataset for electronic exchange under cross-border Directive 2011/24/EU ISO IDMP • Regulation (EC) 520/2012, art.25 and 26 Q1 2015 2017 • System go live Q1 2015 2017 • System go live 2017 2018 • EU implementation roadmap for ISO IDMP compliant substance and product management services and operating model for regulators and pharmaceutical industry • Design of ISO IDMP compatible data management solution for human and veterinary products • Design of a data management solution for substances Q4 2013 2017 • Contribute to the ISO process for finalisation of IDMP standards and technical specifications • Complete updating of documentation based on ISO ballot comments Online programme Extranet Q1 2014 - • Project on hold until after 2018 Intranet n/a Q1 2014 - • Project on hold until after 2018 European medicines web portal • Regulation (EC) 726/2004 • Regulation (EC) 1235/2010, art.26 Q1 2014 2018 • Develop preliminary business case for approval • Begin work on interface design • Develop implementation plan to Work programme 2017 EMA/583016/2016 Page 99/123

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