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Venice Summer School 2009: Course Schedule

Programme 20/07/2009

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Programme

Sunday

Monday

9.00 - 10.30	Lecture 1: Innovation, HTA and Quality in Health Care. An introduction
10.30 - 11.00	Coffee break
11.00 - 12.45	High Level Policy Makers Round-table
12.45 - 14.00	Lunch
14.00 - 15.30	Lecture 2 Innovations – Expectations, Invention vs. Innovation, Drivers, Diffusion, Innovation Management
15.30 - 16.00	Coffee break
16.00 - 17.00	Country case studies on innovations (offered by participants)
17.30 - 19.00	Group Work I
20.00	Dinner

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Lecture 1: Innovation, HTA and Quality in Health Care. An introduction
Lecturer(s)	Reinhard Busse, Professor and Department Head for health care management at Technische Universität Berlin John-Arne Rottingen, Chief Executive, Norwegian Knowledge Centre for the Health Services
Abstract	A framework for improving quality in health care will be introduced with emphasis on innovation, evaluation and HTA (incl. definition and development). Utilizing a model of the health system (cf. article by Velasco Garrido et al.), three different groups of “technologies” will be used as the conceptual model for the course. These are “health technologies within” (= medical/ clinical products and services), “health technologies applied to” (= regulatory and policy measures) and “health technologies outside” (= public health interventions) the health care system.

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High Level Policy Makers Round-table
Lecturer(s)	Enis Baris, Director, Division of Country Health Systems, WHO Regional Office for Europe Nick Fahy, Head of Unit, Health Information, DG SANCO, European Commission John Davis, Head of Division, European Investment Bank Tomica Milosavljevic, Minister of Health, Serbia Sandro Sandri, Regional Minister of Health, Veneto Region Pablo Rivero, Director General of Quality, Ministry of Health, Spain Susanna Axelsson, Project Coordinator, Swedish Council on Technology Assessment in Health Care (SBU)
Abstract	This panel will give the perspectives from WHO Regional Office for Europe, European Investment Bank, European Commission, the EU Presidency (Sweden) and three countries (Serbia, Italy and Spain) on the value attached to innovation, evaluation and HTA in improving the quality of health care at European and national level. Topics to be addressed are: Who is responsible for addressing such issues? Are these topics seen as one entity? Is there one strategy for them? Who is responsible? What do international institutions expect from countries and vice versa?

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Lecture 2 : Innovations – Expectations, Invention vs. Innovation, Drivers, Diffusion, Innovation Management
Lecturer(s)	Katharina Hölzle, Dept. Technology and Innovation Management, Technische Universität Berlin
Abstract	As an introduction to the topic of “innovation” generally and in health care specifically, the following aspects will be addressed: (1) Adequate recognition of innovation incl. definition and types of innovation (e.g. product, process, social and organisational, market), (2) the innovation process, (3) innovation made by lead users and open innovation, (4) innovation promoters and barriers, (5) the role of cooperation incl. cross-functional teams, (6) innovation culture.

Tuesday

9.00 - 10.30	Lecture 3 The core dimensions for evaluating health technologies within health care
10.30 - 11.00	Coffee break
11.00 - 12.30	Lecture 4 The process for evaluating health technologies within health care
12.30 - 14.00	Lunch
14.00 - 15.30	Group Work II
15.30 - 16.00	Coffee break
16.00 - 17.00	Lecture 5 Evaluating health technologies applied to health care. Quality Enhancing Interventions
17.00	Departure for WHO office
18.15 - 19.45	Panel discussion: Role of professional and consumer organizations as well as industry in evaluating technologies and implementing decisions
19.45 - 21.00	Reception and dinner

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Lecture 3 The core dimensions for evaluating health technologies within health care
Lecturer(s)	Kristian Lampe, Senior Medical Officer, Finnish Office for Health Technology Assessment
Abstract	This lecture will focus on understanding which dimensions are currently covered, or rather should be covered, in HTA reports on technologies such as products and services, based on the recently developed “core model” by EUnetHTA. The model distinguishes also between those aspects which are easily transferable from country to country and those for which the evidence is more national. The following topics will be covered: Definitions of HTA, including a historical perspective; HTA in practice today; HTA Core Model – basic concepts and structure; Dimensions of HTA: (1) Health problem and current use of technology; (2) Description and technical characteristics of technology; (3) Safety; (4) Accuracy; (5) Clinical effectiveness; (6) Costs and economic evaluation; (7) Ethical analysis; (8) Organisational aspects; (9) Social aspects; (10) Legal aspects.

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Lecture 4: The process for evaluating health technologies within health care
Lecturer(s)	Reinhard Busse, Professor and Department Head for health care management at Technische Universität Berlin Kristian Lampe, Senior Medical Officer, Finnish Office for Health Technology Assessment John-Arne Rottingen, Chief Executive, Norwegian Knowledge Centre for the Health Services
Abstract	This lecture will look into processes, i.e. who defines which topics are evaluated, how HTA agencies organize their work. It will include: Topic selection and timing of assessments: Who can suggest topics? Formal prioritization criteria; life-cycle of technologies – when should we assess them?; horizon scanning, obsolete technologies HTA project planning: Types of HTAs; scoping of project; stakeholder participation (-> will be discussed in detail in evening panel); speed. Research methodologies: e.g. systematic literature reviews, information sources, choice of comparator, definition of patientrelevant benefits. Reporting: Full report, executive summary etc.; dissemination strat

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Lecture 4: The process for evaluating health technologies within health care
Lecturer(s)	Bernhard Gibis, Head of the Department for Service Contracts and Pharmaceuticals, Federal Association of Statutory Health Insurance Physicians (KBV), Germany Ilaria Passarani, Health Policy Officer, European Consumers' Organisation (BEUC) Pascale Brasseur (Medtronic), Chair of the HTA Group, Eucomed Participants selected from summer school participants
Abstract	This panel session will discuss the roles of important stakeholders in the HTA process: the users of the technologies to provide services (health professionals), the end-user or expected beneficiary (patients and consumers), and the developers of technologies (pharmaceutical and device industry). How should stakeholders be involved? What is the current practice? What should be the ambition on the European level?

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Welcome to the WHO Office in Venice
	Erio Ziglio, Head, WHO European Office for. Investment for Health and Development, Venice

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Lecture 5: Evaluating health technologies applied to health care. Quality Enhancing Interventions
Lecturer(s)	Nicholas Mays, Head of Health Policy in the Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine London School of Hygiene and Tropical Medicine
Abstract	While the preceding lectures have focused on technologies applied within health care, i.e. clinical interventions, this lecture will focus on the second group of technologies applied to the system and how health care management and policy can be improved through the use of research evidence. It will look at the methodological challenges of and different approaches to systematically assessing the evidence on policies and interventions related to governance, organization of care, financing mechanisms and delivery arrangements, including regulatory and quality improvement interventions. Experience from existing initiatives like the UK’s DoH “On-call facility”, the EPOC group of the Cochrane Collaboration and the Observatory policy briefs will be presented.

Wednesday

9.00 - 10.30	Lecture 6a Evaluating health technologies outside health care Lecture 6b Sharing information, cooperation etc. (EUnetHTA, INAHTA, HTAi …)
10.30 - 11.00	Coffee break
11.00 - 12.30	Group Work III
12.30 - 14.00	Lunch
14.00 - 15.30	Lecture 7a Knowledge translation in the health sector Lecture 7b HTA translation into clinical practice (guidelines etc.)
15.30 - 16.00	Coffee break
16.00 - 21.00	Group excursion Villa Contarini, Padova

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Lecture 6a Evaluating health technologies outside health care
Lecturer(s)	Kalipso Chalkidou, Associate Director of Research and Development, National Institute of Clinical Excellence (NICE), UK
Abstract	This lecture will look on the third group of health technologies, i.e. those applied outside clinical care. These are in essence public health interventions like campaigns related to health promotion (nutrition, exercise etc.) and primary prevention. The systematic assessment of such technologies has its particular evaluation challenges (e.g. usually lack of RCT data). Different approaches to do systematic reviews of public health interventions and programmes will be presented, and an emphasis will be put on the experience of NICE in evaluating such technologies and issuing public health guidance since 2006.

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Lecture 6b Sharing information, cooperation etc. (EUnetHTA, INAHTA, HTAi …)
Lecturer(s)	Finn Børlum Kristensen, Chairman of the Executive Committee, European Network for Health Technology Assessment (EUnetHTA) and Director of the Coordinating Secretariat, National Board of Health, Denmark
Abstract	Research information and knowledge are common goods. International collaboration should therefore be an efficient mechanism for improving the quality and quantity of HTA. This lecture will focus on the challenges for collaboration (e.g. all agencies evaluate the same technologies while others are not evaluated), look into specific areas (e.g. horizon scanning) and explore the opportunities and benefits of collaboration. It will introduce the relevant networks for collaboration (INAHTA, HTAi, EUnetHTA), and will explore what the EU Commission and the Member States are expecting in the future from increased collaboration within what is the 4th generation of European HTA collaboration.

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Lecture 7a Knowledge translation in the health sector
Lecturer(s)	Nicholas Mays, Head of Health Policy in the Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine London School of Hygiene and Tropical Medicine
Abstract	One major challenge in health care is the gap between what is known and what we do – the know-do gap. This lecture will present the thinking on how research evidence more effectively can be translated to inform policy making. Different approaches to knowledge translation and knowledge brokering will be explored with a particular emphasis on the health policy and management levels. Evidence from research on the effects and impact of different knowledge translation and exchange efforts will be presented and discussed.

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Lecture 7b HTA translation into clinical practice (guidelines etc.)
Lecturer(s)	Bernhard Gibis, Head of the department for service contracts and pharmaceuticals, National Association of Statutory Health Insurance physicians (KBV)
Abstract	Knowledge translation on the clinical level will be introduced in this lecture. For technologies applied within health care the end objective is that HTA should inform and improve clinical practice. Many measures have been developed to facilitate the implementation and thereby the impact of HTA; among them clinical practice guidelines are probably the most widespread mechanism for issuing clinical policies. Different approaches to the thinking on how HTA should inform clinical practice will be presented, and the effectiveness of different implementation strategies will be explored.

Thursday

9.00 - 10.30	Lecture 8a Lack of evidence – a need for policy-based evidence generation? Lecture 8b HTA-based coverage/ reimbursement decisions on drugs in EU, with possible focus of use of cost-effectiveness data
10.30 - 11.00	Coffee break
11.00 - 12.30	Lecture 9 How to design effective evaluation and decision-making processes and institutions on health system level
12.45 - 14.00	Lunch
14.00 - 16.00	HTA policy-makers round-table: HTA translation into health policy
16.00 - 16.30	Coffee break
16.30 - 18.00	Group Work IV
20.00	Dinner

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Lecture 8a Lack of evidence – a need for policy-based evidence generation?
Lecturer(s)	Kalipso Chalkidou, Associate Director of Research and Development, National Institute of Clinical Excellence
Abstract	In many instances the conclusion of an HTA report is that evidence is lacking or conflicting and that new research is needed for “evidence based policy making”. This lecture will explore the policy options when this is the case as policy makers cannot always wait, and must make decisions. Which approaches should be taken if HTAs cannot give firm evidence? Part of the solution is “policy based evidence generation”. Several countries have introduced mechanisms for facilitating the focused production of new research evidence; examples include the “only in research” decision by NICE, coverage with evidence development (CED) and conditional reimbursement decisions, and commissioning of clinical trials and the setting up of clinical registries.

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Lecture 8b HTA-based coverage/ reimbursement decisions on drugs in EU, with possible focus of use of cost-effectiveness data
Lecturer(s)	Corinna Sorenson, Research Officer, LSE Health, London School of Economics and Political Science
Abstract	Pharmaceuticals are the most highly regulated technology in health care – with harmonized criteria and mechanisms for deciding on market approval on the European level, but decisions on pricing, coverage (i.e. in the benefit basket, the national formulary or similar list of drugs) and reimbursement on the national level. This lecture will explore how HTA at present inform coverage/ reimbursement decisions in European countries, and what may be the future opportunities with increased international collaboration.

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Lecture 9 How to design effective evaluation and decision-making processes and institutions on health system level
Lecturer(s)	Reinhard Busse, Professor and Department Head for health care management at Technische Universität Berlin John-Arne Rottingen, Chief Executive, Norwegian Knowledge Centre for the Health Services
Abstract	This lecture will wrap up the different themes in the course and discuss how the processes of innovation, HTA and evaluation of research evidence may be organized and institutionalised within a health system. It will focus on the role of responsible institutions, e.g. narrow HTA agencies vs. broad-mandate institutions including quality of care; HTA recommendations vs. decision-making power; the roles of academia and professional societies etc. It will also explore the how HTA capacity can be developed within a country.

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HTA policy-makers round-table: HTA translation into health policy
Lecturer(s)	International HTA networks (Finn Børlum Kristensen, EUnetHTA) Role of EU (Nick Fahy, Europea Commission) A regional policy-maker’s view (NN, Veneto) 2 NN from participants
	This panel will focus on the challenges related to translating HTA findings into health policy and clinical practice. The perspectives of the international level (World Bank), European level (WHO Euro, European Commission and EUnetHTA), country and regional levels (participants and Italy) will be represented. Topics to be addressed are: What are the biggest challenges for effective translation? What can be done at the international, European and country levels to facilitate the translation? How can policy makers and administrators promote the use and uptake of HTA at the institutional and clinical levels?

Friday

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