Kick off meeting objectives
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- Audra Patrick
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1 Kick off meeting objectives 1. Understand the overall aims and strategic objectives of Euro Histio net 2. Appreciate how you will contribute to the project s success 3. Develop a greater understanding of the Commission systems and processes Today s agenda Euro histio net, Overall objective, strategy and project management (Jean Donadieu, Anne Skrobot, APHP) Web portal (Jean Donadieu, APHP) WP4 International euro histio net Data base (Nicole Grois, St Anna Kinderspital) WP5 Meet the expert (Itziar Astigarraga,Basque Foundation for Health Research and Innovation) WP6 Guidelines in Langerhans cell histiocytosis therapy work up tissue banking (Ricardo Haupt, Gaslini institute) WP7 Web site for patients and parents (Richard Price, HR trust) WP7 Financial reporting (Anne Skrobot, APHP) Future meetings Other business 1
2 Context: Rare diseases and EU Context: Rare diseases and EU Between 1990 and 2006: Awareness of public health impact of rare diseases is growing Due to patients-parents association Due to Internet technology and «transversal» web site (Orphanet ) or specific disease web site like HS For RD several countries start public health plan to coordinate efforts at national level EMEA and COMP orphan drugs system EU court decision about «cross border» expertise and care Two directions are committed at EU level DG sanco DG research 2
3 In 2004: DG Sanco appointed a task force for Rare diseases (RDTF) Rare Diseases are now a priority in EU public health policy Today: several rare diseases networks have been supported Wilson disease / Rare bleeding disorders / Porphyria Cystic fibrosis / SCN / Myasthenia /Devlpt disorders Two generic projects: ORPHANET - EURORDIS Histiocytosis and EU Two projects funded this year European initiative to improve knowledge, treatment and survival of haemophagocytic syndromes in children (CUREHLH) FP7 about 2 millions Euro Histio Net DG Sanco EAHC about
4 DG sanco projects - organisation Three levels of participation Coordination : management of the budget / distribution to associated partners re imbursement of collaborative partners / reporting Associated partners / Responsible of a work package Collaborative partners / participants to the projects DG sanco projects - financial issue The budget is established between associated partners and DG sanco Each associated partners are asked to take into account its participation (the time given to the project) which is converted in following a daily rate DG sanco give money for extra costs of the project but never reimbursed the contribution of the partners. 3-year project: We have to respect the initial budget The budget will be given in 4 parts: At the start 30% then 3 parts (start year 2, start year 3 and end of project) on the basis of financial reports institutions will make payment in advance. Associated partners had signed a contract with DG Sanco and EAHC Additional contributions could be associated and the initial contract could amended. 4
5 Euro Histio Net Generalities Euro Histio Net Objectives 1 To facilitate the access to information in LCH and associated syndromes For the patients and the families For the doctors 2 To increase the knowledge about epidemiology / risk factors / sequelae to determine better therapeutic measures by setting up a international database 3 To share expertise in difficult case / meet the expert 4 To disseminate guidelines for the diagnosis work up the therapy AND tissue banking 5 To stimulate the links between support association 5
6 What is NOT Euro Histio net 2008 An organisation for clinical trials A help for data monitoring A help for tissue banking It is ONLY a tool to facilitate the communication and researchs about the diseases. The main perspective is public health Key word: A network of referent centers etablished at national level 6
7 Who are the partners ? Associate partners 4 public hospitals with 4 representatives Donadieu / AP HP Paris / Leader Grois / Kinderspital Wien Haupt / Gaslini institute Astiragaga / Fundacion vasca de innovaccione e investigaccion sanitarias 1 Patients/parents association : HR trust Collaborative partners 15 in the project BUT the list is still open for participants Participants from new state members are strongly encouraged From EU or not (but no re imbursement outside EU) Initial Budget : What amount and for what purpose? 420 k are requested About 180 ~k are asked for IT Web portal 40 k Web data base 105 K Web meet the expert session 17 k Web parents Patients 17 k About 60 k is asked for meeting / travels About 180 k is asked for human forces = coordination & organisation 500 K are already our contribution and a total of 900 k as the overall budget 7
8 Answer from PHEA: The project is worth but they give 38% of expected budget Budget Total Request/ obtained Initial proposal nov-07 Distribution of expenses / may - nov 2007 by task (in relative %) 100% 90% 80% 70% 60% 50% IT Coordination Meeting Overhead 40% 30% 20% 10% 0% Initial proposal nov-07 Distribution May Nov 2007 by task in amount in IT Coordination Meeting Overhead Initial proposal nov-07 8
9 Euro Histio Net budget The challenge: to do the same with 38 % of the amount Annex I and Annex II was due Nov 1 st -- final version in may 2008 Initially, agreement to keep all the WP Finally, No, because JI Henter refused SO now: 3 mandatory WP: coordination evaluation dissemination 5 technical WP: 4 around IT (web portal / data base / meet the expert / patients) 1 guideline in LCH M Arico / substitution by R Haupt Timing and organisation more Histiocyte american association grants in march 2008 Histiocyte society Histiocyte society clinical trials (HSCT) Overlapping between the two projects The networks overlapped St Anna is the same coordinator of the HSCT and of the WP Data base of Euro Histio net Overlapping in data collected Differences in legal issue in aims in networks >>>>>> agreement between HS and associated partners july 1 st. Euro histio net official start: Sept 1st, 2008 First income: this week! 9
10 Timing and organisation The IT part: one budget = 72 K in the hand of the CCRI A project manager to help in the organisation of the work (technical specifications/ guidelines/ web entry in several languages) 80 K for the 3 years Profile defined and disseminate 2 CV received to date As to be hired ASAP Travel 36 K for the 3 years Other general task Appointement of a external auditary committee 3 persons S Aymé director Orphanet and coordinator RDTF M Egeler President SIOP former president HS Y Le Cam secretary EURODIS Consortium agreement - Which has to define the relation between all partners - Which could help to add new partners - Communications between partners 10
11 Partners: WP 4: Web Portal AP HP (leader) CCRI-S2IRP BIOEF IGG HRT WP 4: Web Portal A common entry point for several services developed in the project The first task will be to develop web portal content management system in order to be able to manage the development and maintenance of the web site. The general architecture of the project and the project management, the content management system will be formalised in a written document (D1). Hosting, physical security, disaster recovery network security 11
12 WP 4: Web Portal Contents of the web pages will be developed in English and translated, at least in French, Spanish, Italian and German. Selection a subcontractor. All guidelines and documents validated in the different work packages will be issued on the web site by the subcontractor according to specified procedures. WP 4: Web Portal http address already booked A first page could be opened soon just to disseminate a summary of the projects General architecture in the fall draft finalized early 2009 Call for tenders for a IT company early
13 Future meeting and milestones Project manager has to be appointed as soon as possible Consortium agreement has to be draft and approved in the first 6 months Dec th, 2008, Paris: Seminar on data base Technical specifications for web site architecture and web data base has to be written in the first 6 months Opening a preliminary version of the Web site is possible very soon consortium 13
14 Collaborating partners Financial and administrative issues rules of the European commission 14
15 Grant agreement Grant from EC - Total amount: ,00 Euros - Grant of 41.88% = ,00 Euros equivalent to 41,88% of the estimated total eligible costs Duration of the project: 36 months from 01/09/2008 Administrative and financial tasks Deliverables and scientific reports, including the technical and financial intermediate report related to the reporting period Respect the deadlines Advice: to keep regularly updated the accountability of your EU expenditures 15
16 Financing rules and reports (financial and scientifique) 1st pre-financing October % ,20 Euros 2nd pre-financing (after the first year) End % If the consumption of the 1st pre-financing is over 70% after the approval of the interim report covering the period to rd pre-financing (after the second year) End 2010 Final payment (at the end of the project) End % Balance (30% or less) After the approval of the Interim reports covering the period to It could be 30% or less,if depend of the real cost of the project Final reports within 2 months following the closing date of the action 16
17 Eligible costs versus no eligible costs Eligible costs The cost of staff assigned to the action Travel and subsistence allowances (per diem) Equipment Consumables Subcontracting : need a formal contract and a copy should be requested by the EC Overheads : indirect costs (linked to the activities performed within the project) it means for example office supplies, phone, fax, mail services..(no more than 7% of the the total eligible direct costs) =>incurred during the duration of the action, connected with the subject of the GA and indicated in the estimated budget, necessary for the implementation of the action, identifiable and verifiable, reasonable, justified and comply with the requirements of sound of financial management. No eligible costs Return on capital Debt and debt service charges Provisions for losses or potential futur liabilities Interest owed Doubtful debts Exchange losses VAT Costs declared by a beneficiary and covered by an other action of work programme receiving a community grant Excessive or reckless expenditure Contributions in kind Role of project manager Collecting the different scientific information to report to the european commission The go between the partner, the co-ordinator and the european commission Coordination with the AP-HP administrator for the financial statement Delivering different support documents (time sheet/ financial report etc..) Convene meetings and writte minutes Ensure that material on the web-site is up-to-date and relevant 17
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