1 year ago

Work programme 2017


1 these include any

1 these include any interaction that a patient, consumer, carer or healthcare professional may have with the agency, such as, acting as a committee/working party member, reviewing a package leaflet or being invited to a SAG meeting or any other activity which entail engagement from both sides. The figures represent number of interactions (not patients, as the same patient may be involved several times, within different activities at the Agency 2 sharp increase in 2016 due to high demand for graphic representation of reports, for posters and infographics Performance indicators Results Targets 2014 2015 2016 2017 Satisfaction level of Patient and Consumers' Organisations 95% n/a n/a 1 n/a Satisfaction level of SMEs 80% 92% 94% 80% Response to ATD within set timelines 94% 97% 90% Response to RFI within set timelines 97% 100% 97% Satisfaction level from patients and healthcare professionals who received a response from the Agency to their RFI Number of NCAs that have opened their training for inclusion in EU NTC Learning Management System Number of users registered to the EU NTC Learning Management System Number of NCA experts registered to the EU NTC Learning Management System 81.7% 77% 70% n/a 6 14 20 n/a n/a 2,117 3,000 n/a n/a 1,225 1,600 Satisfaction level of partners/stakeholders with EMA n/a 80% n/a 80% communications as per “EMA perception survey for communication” Key messages included in media articles generated by EMA press releases: At least 1 key message 100% 100% 95% At least 2 key messages 100% 51% 70% Quote included 60% 0% 2 60% Average rating given to pages on corporate website during 3.6 3.0 the year 1 the results not yet available, but will be finalised during Q1 2017 2 no monitoring was done for quotes Additional objectives and activities Medium-term objective MAWP initiative Activity description Timeframe Start End Enhance cooperation within European medicines regulatory network 3.1-1 Conduct horizon-scanning to identify 2015 2017 emerging trends at an early stage and to ensure appropriate expertise is available and improve regulatory preparedness, including through supporting the work undertaken by the Innovation Network and EU Network Training Centre 3.2-9 Complete the data-gathering initiative for 2016 2017 Work programme 2017 EMA/583016/2016 Page 90/123

Medium-term objective MAWP initiative Activity description Timeframe Start End Strengthen stakeholder relation focusing on patients and consumers, healthcare professionals, industry associations and academia Further develop support to and strengthen stakeholder relations with SMEs Further strengthen Agency's transparency and open data commitments non-fee generating activities 1.3-3 Implement a framework for collaboration with Q4 2017 2018 3.1-7 academia with respect to human medicines and consider the need for any specific adaptations to the framework with respect to veterinary medicines 3.4-6 Conduct a survey to monitor the interaction 2017 2017 with industry associations Publish an annual report on EMA's interaction Q4 2017 2017 with industry associations 3.4-4 Publish an annual report on EMA's interaction with patients, consumers, healthcare Q4 2017 After 2018 professionals and their organisations 3.4-5 Implement recommendations to promote GPs 2016 2018 interactions with EMA 1.2-6 Propose and agree additional processes to capture patient views and preferences within benefit/risk evaluations at CHMP, following the outcome of the pilot phase of patient involvement in CHMP oral explanations and the research projects on elicitation of patient preferences 2016 2017 Explore most optimal way to report patient input and values in the relevant assessment reports, in line with the EMA AddValue project 2016 2017 1.3-7 Implement action plan arising from 10-year 2016 2018 report on the implementation of the SME Regulation Deliver high quality guidance and systems for 2016 2017 optimal use of available regulatory tools for SMEs (EU e-SME application) to facilitate efficient and effective access to support measures 1.4-3 Complete the reflection paper on providing 2016 2018 access to individual patient data 1.4-5 Publish the clinical data under phase I of the 2017 2017 policy on publication of clinical data Assess implementation of the policy on Q3 2017 Q4 2017 publication of clinical data and publish a report Establish a technical group on anonymisation Q2 2017 2018 of patient data and hold regular discussions 1.4-5 Finalise the transparency road map following 2016 2018 1.4-6 1.4-7 public consultation on the draft roadmap Conduct public consultation and finalise the 2016 2017 Work programme 2017 EMA/583016/2016 Page 91/123

2017 Work Programme
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