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Work programme 2017

WC500221614

Objective 3: Ensure best

Objective 3: Ensure best use of resources through promoting mutual reliance and work-sharing Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Expand work-sharing and 4.3-1 Support the Commission with the 2016 2018 High - principles of mutual recognition agreed mutual-reliance initiatives establishment of a Mutual Recognition and implemented for certain group of Agreement with the US medicines 4.3-2 Increase information-sharing between regulators responsible for the conduct Contin uous Contin uous High - GCP initiative with PMDA established - pharmacovigilance inspection initiative of clinical trials and pharmacovigilance with FDA established activities Increase reliance of other 4.3-3 Extend cooperation on the evaluation 2017 2019 Medium - document on good-reliance practices Efficient use of global resources regulators on European assessments and outputs of generic medicines, to promote leveraging regulatory authorities' collective resources 4.3-4 Improve existing mechanisms for sharing and exchanging information with other regulators on products throughout their lifecycle 4.3-5 Explore opportunities to leverage resources in other areas and increase reliance of other regulators on European assessments and outputs 2017 2019 Medium - agreement on template for sharing confidential information 2017 2019 Medium - number of areas identified where reliance on European assessments can be increased Work programme 2017 EMA/583016/2016 Page 40/123

Objective 4: Support training and capacity building and promote the EU regulatory model Area Medium-term objective No Initiative(s) Start End Priority Performance indicator(s) Training and capacity-building for non-EU regulators Support capacity-building of non-EU regulators 4.4-1 Organise regular training courses for GXP inspectors, with participation of non-EU regulators 4.4-2 Extend the Network Training Centre to involve non-EU regulators Contin uous Contin uous High - number of training sessions organised with non-EU regulator participation - number of non-EU regulators' representatives trained 2016 2018 Medium - increased number of participants from developing countries / non-EU regulators Work programme 2017 EMA/583016/2016 Page 41/123

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