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Work programme 2017

WC500221614

Area Medium-term

Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Achieve a sustainable financing model for the network Strive for adequate and interoperable IT services for human medicines reporting, signal management and incident management 3.2-4 Improve the efficiency of EMA corporate support activities 2016 2017 Medium - integrated planning and reporting system introduced 3.2-5 Ensure EMA has the right capabilities to deliver its mission 2016 2020 High - mapping of future needs versus current internal expertise completed - targeted recruitment undertaken 3.2-6 Analyse experience with the current legal provisions to identify gaps and 2017 2020 Medium - number of analyses conducted - number of contributions to the EC made provide subsequent input to the EC for any review of current legislation 3.2-7 Participate in the BEMA exercise as per the agreed BEMA cycle 2016 2020 Medium - participation undertaken as per the agreed BEMA cycle - review of quality-management framework undertaken and resulting actions implemented 3.2-8 Provide regular training to BEMA assessors 2016 2020 Medium - number of assessors trained within a BEMA cycle - number of training sessions provided 3.2-9 Complete the data-gathering initiative 2015 2017 High - data-gathering initiative conducted as per the action plan 3.2-10 Contribute to external evaluation of the 2016 2017 High - contribution available as per the agreed current fee regulation action plan 3.2-11 Deliver IT solutions in accordance with 2016 2020 High - IT systems/solutions delivered and in the Information Management Strategy operation aligned with the EU Telematics Strategy 3.2-12 Establish and improve EMA information 2016 2020 High - information services operated with services processes that are monitored and Work programme 2017 EMA/583016/2016 Page 32/123

Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) continuously improved 3.2-13 Share information on medicines within 2016 2020 High - access provided to clinical data the network and with stakeholders - European Medicines Web Portal operational - improved provision of data and analytical capability Strengthen the quality of the 3.2-14 Achieve common standards of scientific 2016 2018 High - availability of improved templates and a scientific review processes quality across the network guideline for completing the templates - availability of accepted standards against which the quality of outputs can Quality of scientific outputs 3.2-15 Develop and maintain state-of-the-art scientific guidelines 3.2-16 Improve the benefit-risk methodology and expand it to post-authorisation updates be measured 2016 2019 High - revised procedure and harmonised standards for guideline development and revision - number of new/revised guidelines 2016 2017 High - utilisation of the effects table in pilot post-authorisation procedures Objective 3: Ensure effective communication of and within the network Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Building/ maintaini Run necessary communication initiatives to support achieving strategic goals 3.3-1 Develop and implement a five-year EMA communication strategy 2016 2020 High - framework strategy for external communication approved and implemented, supported by annual communication plans Work programme 2017 EMA/583016/2016 Page 33/123

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