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Work programme 2017

WC500221614

ecognised as value

ecognised as value added, and will continue to be sought where applicable to best inform these decisions. In accordance with the pharmacovigilance legislation, the Agency is implementing public hearings for safety-related referrals. Workload indicators Results Forecasts 2014 2015 2016 2017 Pharmacovigilance referrals started 7 5 8 8 Non-pharmacovigilance referrals started 11 16 10 12 Performance indicators Results Targets 2014 2015 2016 2017 Referral procedures managed within the legal timelines 100% 100% 100% 100% Additional objectives and activities In addition to delivering its regular activities regarding referrals for human medicinal products, the Agency plans to undertake and progress the following additional activities: Medium-term objective MAWP initiative Activity description Timeframe Start End Provide high quality, robust, scientifically sound and consistent scientific assessments of referrals Ensure and run highly effective and efficient processes to deliver assessment of referrals 3.2-1 Develop and improve guidance and provide internal training to ensure regulatory procedural consistency 3.2-1 Optimise and embed in the Agency a process performance management system with strong customer focus on quality, simplification and regulatory procedural excellence Create a platform for collaboration with NCAs to understand level of satisfaction and identify improvement opportunities Review and rationalise the involvement of multiple Committees in the evaluation of safety issues in the post-authorisation phase Implement identified improvements to handling procedures for CAPs and NAPs 2016 2017 2016 2018 2017 2018 2017 2018 2016 2018 Resources 2017 Financial resources (cost, thousand Euro)* 2,006 Work programme 2017 EMA/583016/2016 Page 56/123

Human resources (FTEs)* 8 2017 * Excludes resources related to pharmacovigilance referrals 1.5. Pharmacovigilance and epidemiology activities Activity area Pharmacovigilance covers the science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions (ADRs) or any other medicine-related problem. The Agency coordinates the EU pharmacovigilance system that connects the systems of each national competent authority, and operates pharmacovigilance processes that support both the EU pharmacovigilance system and the recommendations and opinions of the EMA committees on the benefits and risks of medicines. Pharmacovigilance activities are integrated with many aspects of the Agency's processes, including evaluation (for centrally authorised procedures), post-authorisation referrals, inspections and data-management, and therefore related items are found also in those sections of this document. The area covers: • management of adverse drug reaction reports, periodic safety update reports (PSURs), riskmanagement plans and oversight of post-authorisation studies; • cooperation with NCAs in the management of safety signals for centrally authorised products and nationally authorised products, and of emerging safety issues and (safety) incidents; • coordination of safety communications; • publication of lists of products, including EU reference dates (for PSURs), products under additional monitoring and withdrawn products; • coordination of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which builds capacity in the delivery of post-authorisation studies; • development and maintenance of good pharmacovigilance practices (GVP) and standards for the system, as well as development and implementation of evidence-based process improvements and updates to GVP. Drivers There is increasing realisation that pharmacovigilance plays a critical role through the lifecycle of medicines. This includes the importance of early pre-authorisation planning of data collection for when products are released onto the market and the reliance placed on pharmacovigilance systems for the monitoring of products and the rapid detection of and action taken on emerging safety issues. Therefore the Agency will further support the planning and operation of pharmacovigilance and risk management to help fulfil the unmet medical needs of patients. Having finished implementing the pharmacovigilance legislation in 2017, the coordinating role of the Agency in the monitoring of all EU medicines has increased. This means the volume of data and Work programme 2017 EMA/583016/2016 Page 57/123

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