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Eunethta JA3 To view drawing guides 1.Right-click on slide and select ’Grid and Guides...’ 2.Check ’Display drawing guides on screen’ 3.Select ’OK’ Presentation title maximum three lines Press ‘Caps locked’ for title in Caps EUnetHTA JA3 an update and future initiatives Presentation subtitle maximum three lines of text Wim Goettsch Director EUnetHTA JA3 Directorate Brussel, February 15, 2018 1 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Outline • Update on WP activities • Interaction with stakeholders/EMA • Future perspectives/developments in EUnetHTA o Regional initiatives o Towards a permanent model 2 European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu Summary of Activities in EUnetHTA JA3 Maximum two lines in header Press ‘Caps locked’ • WP4 Joint Production for title in Caps o To produce rapid REA on pharmaceuticals and other technologies; Text starts with no-bullet o To provide a system for topic selection and prioritization, e.g. horizon scanning. To add pre-formatted bullet text please use the Increase/Decrease Indent • WP5 Evidence Generation buttons found in the Top-PowerPoint menu o To conduct Early Dialogues (joint HTA or parallel/joint with regulators); o To cooperate on additional post-launch data collection to be used in various contexts (such as MEAs, CED). Change fact box colour Click on box, choose between • WP6 Quality Management the five highlighted colours under Shape fill o To provide quality management for EUnetHTA joint products; o To further develop methodologies and tools for joint work if necessary. • WP7 National implementation and impact o To facilitate the reuse and implementation of joint products at the national/local level; o To measure the impact of joint work in collaboration with other work packages. • WP1 Coordination • WP2 Dissemination • WP3 Evaluation European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu 3 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu WP4 Status Joint and Collaborative Assessments Other technologies planned ongoing published 2 CA 2 JA 4 CA 13 5 CA Pharma technologies published 3 JA 3 European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 4 Status REA Other technologies Future relevant activities for WP4 Maximum two lines in header Press ‘Caps locked’ for title in Caps • Changes to the pharma JA o Simplify the production process (no draft submission file, focus on PICO) Text starts with no-bullet To add pre-formatted bullet text please use the o Adapt EUnetHTA JA templates (readability), simplify process Increase/Decrease Indent buttons found in the o More actively contacting manufacturers on products of interest for HTA bodies Top-PowerPoint menu • Working group for Topic Identification, Selection and Prioritisation (TISP) o Both on pharma and non-pharma activities o Also links to horizon scanning activities • Additional activities on Medical devices o EUnetHTA Task Force on HTA and medical device regulation (first meeting May 29) • Interaction with regional initiatives (discussed later) European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 5 WP5A - Early Dialogues – Status since JA3 start Maximum two lines in header Press ‘Caps locked’ for title in Caps 20 Letters of Intent Text starts with no-bullet To add pre-formatted • 8 Oncology bullet text please use the Increase/Decrease Indent • 2 Neurology buttons found in the Top-PowerPoint menu • 2 Immuno-inflammation • 1 Ophthalmology • 1 Vaccine 3x withdrawn • 1 Metabolic disorder 10x EDWP • 1 ophthalmology • 1 infectious disease • 1 oncology • 2 Hematology 3 multi-HTA EDs + 7 PCC • 1 vaccine • 4 oncology • 1 neurology • 1 metabolic disorder 7x individual • 2 Hematology PCI (~2-3 HTABs) • 1 infectious disease • 4 oncology • 1 immuno-inflammation • 1 neurology • 1Immuno- 4 Completed inflammation • 1 infectious disease 4 Completed European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu European network for Health Technology Assessment | JA2 2012- 2015 | www.eunethta.eu WP5B: Post Launch Evidence Generation (PLEG) Maximum two lines in header Press ‘Caps locked’ for title in Caps • B1- PLEG Pilots: Text starts with no-bullet To add pre-formatted bullet text please use the o Disease specific pilots : Increase/Decrease Indent buttons found in the . Two ongoing: two qualification of registries, in collaboration with EMA Top-PowerPoint menu o Product-specific pilots: . Calls for pilots on drugs about to be launched (two topics proposed by AIFA and TLV) . Calls for pilots on medical devices expected in March • B2 - Quality standards tool to evaluate registries o Second draft of the tool currently tested by three HTA bodies (AQuAS, avalia- t, INFARMED) o Third draft of the tool together with first draft of the Vision paper for independently accrediting or assuring registers: expected March 2018 European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu Maximum two WP 6 - Quality management, guidance lines in header Press ‘Caps locked’ for title in Caps and tools Change or edit chart 1. Right click on chart 2a. Select Change Type and choose a new chart type from the viewed selection 2b. Select Edit Data and fill in the new data Pre-designed chart 1. Click Chart icon or chart 2. Insert pre-designed chart from Templates European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 8 The EUnetHTA Companion Guide - status European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 9 European network for Health Technology Assessment | JA3 2016- 2020 | www.eunethta.eu WP 7 Status of activities Activity Due date Status Activity 1: Final report Nov ’17 • Final report is publically available on the EUnetHTA website Research and (deliverable) analysis Activity 2: Case Ongoing throughout • Year 1 case studies published in the activity 1 report studies JA3 • Year 2 case studies to take place in April and May so as to include discussion of the EC proposal for a regulation on HTA • 4 countries have volunteered for year 2 Activity 3: Delayed to account • Activity to be initiated following liaison with WP1 Technical to for publication of the support EC proposal for a development of regulation on HTA the model of HTA cooperation Activity 4: Implementation • Data collection procedures to gather experiences of using the Implementation reports to be EUnetHTA assessments in place Network published May • The first implementation report will include: 2018, Nov 2018, • a baseline to measure assessment use in JA3 May 2019, Nov • first implementation data from JA3 assessments 2019 European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 10 Maximum two lines in header Press ‘Caps locked’ for title in Caps Future work Text starts with no-bullet To add pre-formatted • Ongoing collection and publication of data (quantitative and bullet text please use the Increase/Decrease Indent qualitative) about use of the JA3 EUnetHTA assessments; buttons found in the Top-PowerPoint menu • Collaborative work with WP6B among HTA users about incorporating EUnetHTA tools and guidelines in their national procedures; • Develop resources and run activities to support implementation of EUnetHTA outputs; • Support the development of the model of HTA cooperation. European network for Health Technology Assessment | JA3 2016 - 2020 | www.eunethta.eu 11 WP1 Output and Milestones in 2017 Participation, Contribution and Coordination Products Reporting and Services Increased Technical Publication and Network Capabilities European network for Health Technology Assessment | www.eunethta.eu Assembly and Forum, HTA Synergy, EUnetHTA-EFPIA Technical Meeting, Maximum two EUnetHTA-EMA bilaterals, Executive Board/Project Management Group Face-to- lines in header Press ‘Caps locked’ Face, involvement and contribution to European-wide symposiums and for title in Caps organizations Text starts with no-bullet To add pre-formatted bullet text please use the Increase/Decrease Indent Submission of Interim Technical and Financial Report (81 partner organisations and buttons found in the Top-PowerPoint menu institutions) Change fact box colour EUnetHTA-EMA Parallel Consultation Process (Early Dialogues) and continued Click on box, choose between the five highlighted colours production of REAs under Shape fill Internal monthly summaries and quarterly EUnetHTA magazine; interview and publication pieces in journals and web New Intranet infrastructure (400+ users): development of Project Management Tool (PMT), Advanced Address Book (AAB); 30% increase in social media base; launch of rebuilt website is imminent European network for Health Technology Assessment | www.eunethta.eu 13 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu WP2 activities Maximum two lines in header Press ‘Caps locked’ for title in Caps • Involvement in communication activities • Dissemination registry • Training: o Training Strategy o A virtual classroom with training materials for partners o A Welcome Package for newcomers • Stakeholder Involvement activities o Overall Stakeholder Involvement SOP o Stakeholder Registry European network for Health Technology Assessment | www.eunethta.eu 14 Maximum two lines in header Press ‘Caps locked’ for title in Caps Text starts with no-bullet To add pre-formatted bullet text please use the Increase/Decrease Indent buttons found in the Top-PowerPoint
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