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Work programme 2017

WC500221614

Theme 3: Optimising the

Theme 3: Optimising the operation of the network Objective 1: Reinforce the scientific and regulatory capacity and capability of the network Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Regulatory capability and capacity Ensure 'fit-for-purpose' scientific capability of the network Ensure optimal organisation of the available expertise within the network for services provided to EMA 3.1-1 Conduct horizon-scanning to ensure understanding of and preparedness for emerging technologies in medicines, 2016 Contin uous High - inventory of needs available - mapping of expertise versus needs available and identify gaps in expertise 3.1-2 Deliver curricula for competence development on the basis of the 2016 2017 Medium - action plan available - number of curricula drafted identified needs 3.1-3 Develop a catalogue of training material through the EU Network Training Centre 2016 2019 Medium - training material catalogue developed - number of training courses - number of NCAs that have opened their training for inclusion in EU NTC 3.1-4 Provide continuous training through the EU Network Training Centre in accordance with an agreed action plan 2014 Contin uous Medium - training programme available and implemented - number of training sessions provided - number of experts trained, including in specific (gap) areas 3.1-5 Monitor and improve implementation of 2016 2020 Medium - increase in the number of MNAT the multinational assessment team procedures (MNAT) approach pre-authorisation - implementation level of the identified improvements 3.1-6 Implement the multinational 2016 2019 Medium - increase in the number of MNAT assessment team approach postauthorisation procedures in a phased approach - implementation level of the identified improvements 3.1-7 Enhance outreach for academic 2017 2019 Medium - implementation of the framework of Work programme 2017 EMA/583016/2016 Page 30/123

Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) expertise for services provided to EMA, interaction with academia in particular as regards innovation of medicines Scientific and regulatory expertise Strike an optimal balance between ensuring impartiality/independence of experts and securing the best possible scientific expertise 3.1-8 Undertake annual review of the EMA independence policies to identify room for improvement to strike such balance 2016 2020 Medium - annual review of all policies prepared and discussed by the Management Board - agreed improvements implemented Objective 2: Strive for operational excellence Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Optimise the current regulatory 3.2-1 Undertake a continuous review and 2016 2020 High - processes maintained /updated using framework by ensuring improvement of the centralised an agreed methodology Sustainability of the regulatory system efficiency of the existing regulatory operations procedural management 3.2-2 Undertake a continuous review and improvement of the EMA support to scientific committees/working parties/expert groups 3.2-3 Undertake a revision of the operation of the EU pharmacovigilance system - key interfaces with network and industry enhanced (as demonstrated using surveys, workshops, etc.) - increased efficiency of the processes 2016 2020 High - increased productivity of the committees - optimised product support and guideline generation activities, following revision of the working party utilisation 2017 2020 High - process improvements/efficiency gains implemented in the areas of ADR Work programme 2017 EMA/583016/2016 Page 31/123

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