INTERNATIONAL RELATIONS OFFICE OF RARE DISEASES
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2 INTERNATIONAL RELATIONS OFFICE OF RARE DISEASES STAFF Head Arrigo SCHIEPPATI, M.D.
3 CURRICULA VITAE Arrigo Schieppati got his degree in Medicine at the University of Milan in 1978 and the specialisation in Medical Nephrology in 1984 at the same University. He performed his training at the Mario Negri Bergamo Laboratories with Dr. Remuzzi, and completed it with stages at the laboratories of prof. Patrono (Catholic University in Rome), prof. John Gordon (Cambridge, GB), and at the Division of Renal Diseases - University of Colorado Medical School, directed by Dr. Schrier (Denver, USA). Since 1982 he works at the Division of Nephrology and Dialysis Riuniti Hospital Bergamo, where he is in charge of Outpatients Clinic and Day Hospital : Chief, Information Center for Rare Diseases : Chief, Laboratory for Coordination of Information and Diagnosis of Rare Diseases 2009 to date: Chief, International Relations Office of Rare Diseases. Areas of interest: diagnosis and therapy of chronic renal diseases, hypertension and rare kidney diseases. Affiliations: ethical committee Riuniti Hospital - Bergamo; member of the working group of the regional network for rare diseases in Lombardy; scientific committee Bolognini Hospital Seriate (BG); member of the Task Force on Rare Diseases (DG Health and Consumer Protection); International Society of Nephrology; American Society of Nephrology; Editorial Board Journal of Nephrology. Principali pubblicazioni 1. Whitfield K, Huemer KH, Winter D, Thirstrup S, Libersa C, Barraud B, Kubiak C, Stankovski L, Grählert X, Dreier G, Geismann S, Kuchinke W, Strenge-Hesse A, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, Serrano M, de Andres F, Sanz N, Hernández R, Kreis G, Asker-Hagelberg C, Johansson H, Asghar A, Husson JM, Demotes J, Gluud C. Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries. Trials Nov 12;11: Schieppati A, Henter J I, Daina E, Aperia A. Why rare diseases are an important medical and social issue. Lancet June 14; 371: Schieppati A, Remuzzi G. Chronic renal diseases as a public health problem: epidemiology, social, and economic implications. Kidney Int Suppl Sep;(98):S7-S Remuzzi G, Schieppati A, Boissel JP, Garattini S, Horton R. Independent clinical research in Europe. Lancet Nov 6-12;364(9446): Schieppati A, Perna A, Zamora J, Giuliano GA, Braun N, Remuzzi G. Immunosuppressive treatment for idiopathic membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev Oct 18;(4):CD Remuzzi G, Schieppati A, Ruggenenti P. Clinical practice. Nephropathy in patients with type 2 diabetes. N Engl J Med Apr 11;346(15): Schieppati A, Remuzzi G, Garattini S. Modulating the profit motive to meet needs of the less-developed world. Lancet Nov 10;358(9293):
4 INTRODUCTION TO THE LABORATORY S ACTIVITIES The International Relations Office of Rare Diseases has been established in It represents the evolution of the previous Laboratory mainly dedicated to information about rare diseases. The Laboratory represents also the evolution of the Mario Negri Institute activities in the field of rare diseases, with particular attention to the European collaborations.
5 FINDINGS/MAIN RESULTS Italian National Institute of Health Assessorato alla Sanità, Lombardy Region UNIAMO - Rare Diseases Italian Federation Riuniti Hospital, Bergamo BergamoScienza Association NATIONAL COLLABORATIONS INTERNATIONAL COLLABORATIONS ICORD Society - International Conference on Rare Diseases and Orphan Drugs EURORDIS Rare Diseases Europe, non-governmental patient-driven alliance ECRIN - European Clinical Research Infrastructures Network ICRDOD - Information Centre for Rare Diseases and Orphan Drugs, Bulgaria Journal of Nephrology EDITORIAL COMMITTEE MEMBERSHIP NATIONAL AND INTERNATIONAL COMMITTEE MEMBERSHIP External Advisory Board E-Rare (ERA-Net for research programs on rare diseases). Network for Rare Diseases Lombardy Region (Delibera Regione Lombardia N 7328, 11/12/2001) Scientific Committee A.O. Bolognini di Seriate Ethical Committe, A.O. Ospedali Riuniti di Bergamo EVENT ORGANIZATION PARTICIPATION IN EVENTS IN WHICH THE LABORATORY WAS INVOLVED EUROPLAN Final Conference Roma, february 25, 2011 Meeting BURQOL_RD Madrid, may 23, 2011 Riunione Tecnica Progetto BURQOL-RD Roma, september 12, 2011 Convegno Genetica e sordità, recenti acquisizioni cliniche e biologiche Varese, december 14, 2011 European Commission (DG SANCO) GRANTS AND CONTRACTS
6 SELECTION OF SCIENTIFIC PUBLICATIONS FROM 2011 Remuzzi G, Schieppati A Why rare diseases. Ann. Ist. Super Sanità 2011; 47: OTHER PRODUCTS PUBLISHED IN 2011 Arrigo Schieppati La coda lunga dell'11 settembre Pubblicato su Scienza in Rete, 14 settembre, 2011 ( Giuseppe Remuzzi, Arrigo Schieppati Ricerca scientifica e paradossi italiani Corriere della Sera Salute, 13 ottobre 2011 Arrigo Schieppati L'eclissi della scienza in Italia Pubblicato su Scienza in Rete, 14 ottobre, 2011 (
7 RESEARCH ACTIVITIES EUROPLAN - European Project for Rare Diseases National Plans Development EUROPLAN is a three-year project of the Programme of Community action in the field of Public Health, which began in April 2008, and is promoted by the DG Sanco. The main goal is to provide National Health Authorities with a supporting tools for the development and implementation of National Plans and Strategies for rare diseases (RDs) following the recently agreed European Council Recommendation on an action in the field of RDs (2009/C 151/02). This supporting tools will be composed of three documents focused on defined priority areas: the Guidance document on recommendations for the definition and implementation of National Plans and Strategies for rare diseases; the report on current practices and relevant cases in the field of rare diseases; and the document on the recommended set of indicators for monitoring and evaluating the implementation of national initiatives. The National Centre for Rare Diseases (Italian Institute of Health - Istituto Superiore di Sanità, Italy) is the leading partner that organize the contributions from 25 countries and EURORDIS (the European Organisation for rare diseases) ensuring a broad representation of different EU contexts and experiences and patients point of view. The Mario Negri Institute collaborates in the EUROPLAN Project as scientific counsellor. In addition, the project ensures an inclusive and wide engagement of stakeholders - Ministries, regional and local authorities, health care planners, programme managers, health care professionals, researchers and patients. EUROPLAN Projects is divided in seven work packages: Area 1. Plans or strategies in the field of rare diseases Area 2. Adequate definition, codification and inventorying of rare Diseases Area 3. Research on rare diseases Area 4. Centres of expertise and european reference networks for rare Diseases Area 5. Gathering the expertise on rare diseases at european level Area 6. Empowerment of patient organisations Area 7. Sustainability European Clinical Research Infrastructures Network ECRIN The European Clinical Research Infrastructures Network (ECRIN) is a sustainable, not-for-profit infrastructure supporting multinational clinical research projects in Europe. ECRIN provides information, consulting and services to investigators and sponsors in the preparation and in the conduct of multinational clinical studies, for any category of clinical research and in any disease area. This is particularly relevant for investigator-initiated or small and medium enterprise-sponsored clinical trials, and for clinical research on rare diseases where international cooperation is a key success factor. ECRIN is based on the connection of coordinating centres for national networks of clinical research centres and clinical trials units, able to provide support and services to multinational clinical research. ECRIN offers integrated support to multinational clinical research projects through information, consultancy, and a set of flexible services, for any category of clinical research, in any medical field. This support is provided by the distributed infrastructure connecting national ECRIN partners (networks of Clinical Research Centers or Clinical Trials Units). Social economic burden and health-related quality of life in patients with rare diseases in Europe - BURQOL-RD BURQOL-RD is a 3 year project under the 2nd Programme of Community Action in the Field of Public Health, that commenced in April 2010 and is promoted by the DG Sanco. The main aim of BURQOL-RD is to generate a model to quantify the socio-economic costs and Health Related Quality of Life (HRQOL), of both patients and caregivers, for up to 10 rare diseases in different European countries. This model will be adaptable and sufficiently sensitive to capture the differences in the distinct Health and Social Care Systems in the EU Member States. The information generated by the BURQOL-RD consortium will help to: design future policies in the area of rare diseases, which will ultimately have positive benefits
8 for EU citizens health, both that of patients and of their caregivers; readily transfer the protocols established to other RD and to other countries; compare the availability and access to specific health resources for specific RD in each country; explore the potential relationships between HRQL and access to healthcare resources. After a thorough selection process, a set of 10 rare diseases to be targeted was decided: cystic fibrosis, Prader-Willi sindrome, haemophilia, Duchenne muscular dystrophy, epidermolysis bullosa, fragile X syndrome, scleroderma, mucopolysaccharidosis, juvenile idiopathic arthritis, histiocytosis. The questionnaires have been implemented by FUNCIS and translated for the Italian reality by the Italian partners of the BURQOL project (Mario Negri Institute, Italian National Institute of Health, Bocconi University). Next February and March 2012, the diffusion of the questionnaires will depart among the patients associations, that will ask to their families and associates to participate in the study compiling online the questionnaires. The contacts among the Italian researchers that will participate in BURQOL project and the associations of the patients, has been supported by the Rare Diseases Italian Federation UNIAMO. Next annual meeting for participants will be organized at Bruxelles in May Mario Negri Institute partecipates in the project BURQOL-RD as associated partner.
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