IMI2 PROPOSAL TEMPLATE FIRST STAGE PROPOSAL

Transcription

1 IMI2 PROPOSAL TEMPLATE FIRST STAGE PROPOSAL IN TWO-STAGE PROCEDURE (TECHNICAL ANNEX) RESEARCH AND INNOVATION ACTIONS & INNOVATION ACTIONS Nte: This is fr infrmatin nly. The definitive template fr yur call will be available in the submissin system, which yu can then use when writing yur prpsal. Please fllw the structure f this template when preparing yur prpsal. It has been designed t ensure that the imprtant aspects f yur planned wrk are presented in a way that will enable the experts t make an effective assessment against the evaluatin criteria. Sectins 1, 2 and 3 each crrespnd t an evaluatin criterin fr a shrt prpsal. Please be aware that prpsals will be evaluated as they were submitted, rather than n their ptential if certain changes were t be made. This means that nly prpsals that successfully address all the required aspects will have a chance f being funded. There will be n pssibility fr significant changes t cntent, budget and cnsrtium cmpsitin during stage tw ther than changes resulting frm the merger with the industry cnsrtium. Page limit: Fr first stage prpsals, the cver page, and sectins 1, 2, 3 and 4 tgether shuld nt be lnger than 30 pages, with n mre then 5 pages fr sectin 4 (Participants). All tables in these sectins must be included within this limit. The minimum fnt size allwed is 11 pints. The page size is A4, and all margins (tp, bttm, left, right) shuld be at least 15 mm (nt including any fters r headers). The page limit will be applied autmatically; therefre yu must remve this instructin page befre submitting. If yu attempt t uplad a prpsal lnger than the specified limit befre the deadline, yu will receive an autmatic warning and will be advised t shrten and re-uplad the prpsal. After the deadline, excess pages (in ver-lng prpsals/applicatins) will be autmatically made invisible, and will nt be taken int cnsideratin by the experts. The prpsal is a self-cntained dcument. Experts will be instructed t ignre hyperlinks t infrmatin that is specifically designed t expand the prpsal, thus circumventing the page limit. Please d nt cnsider the page limit as a target. It is in yur interest t keep yur text as cncise as pssible, since experts rarely view unnecessarily lng prpsals in a psitive light. IMI/INT/ Versin Nvember 2017 Tel +32 (0) Fax +32 (0) infdesk@imi.eurpa.eu Pstal address: IMI JU TO Brussels Belgium Visiting address: Ave de la Tisn d Or Brussels Belgium

2 COVER PAGE Title f Prpsal List f participants Participant N * Participant rganisatin name Cuntry 1 (Crdinatr) 2 3 * Please use the same participant numbering as that used in the administrative prpsal frms. Table f Cntents IMI2 RIA & IA PROPOSAL TEMPLATE Page 2 f 6

3 1. EXCELLENCE Yur prpsal must address an IMI2 JU Annual Wrk Plan tpic fr this call fr prpsals. This sectin f yur prpsal will be assessed nly t the extent that it is relevant t that tpic. 1.1 Objectives Describe the specific bjectives fr the prject, which shuld be clear, measurable, realistic and achievable within the duratin f the prject. Objectives shuld be cnsistent with the expected explitatin and impact f the prject (see sectin 2). 1.2 Relatin t the call tpic text. Indicate the call tpic t which yur prpsal relates, and explain hw yur prpsal addresses the specific challenge and scpe f that tpic; meet all key bjectives as set ut in the tpic text. 1.3 Cncept and apprach Describe and explain the verall cncept underpinning the prject. Describe the main ideas, mdels r assumptins invlved. Identify any trans-disciplinary cnsideratins. Describe the psitining f the prject e.g the unmet medical need addressed, where it is situated in the medicines develpment cycle (frm early discvery t access), the cntributin t the IMI2 JU bjectives; Describe any natinal r internatinal research and innvatin activities which will be linked with the prject, especially where the utputs frm these will feed int the prject; Describe and explain the verall apprach and methdlgy, distinguishing, as apprpriate, activities indicated in the relevant sectin f the IMI2 JU Annual Wrk Plan, e.g. fr research, demnstratin, pilting, first market replicatin, etc. Describe hw the necessary expertise have been mbilised t achieve the bjectives f the tpic, t ensure engagement f all relevant key stakehlders and t cmplement the industry cnsrtium. Where relevant, describe hw sex and/r gender analysis is taken int accunt in the prject s cntent. When relevant elabrate n any ethics strategy that may be linked t the credibility f the prpsed apprach. 1.4 Ambitin Sex and gender refer t bilgical characteristics and scial/cultural factrs respectively. Fr guidance n methds f sex / gender analysis and the issues t be taken int accunt, please refer t: Describe the advance yur prpsal wuld prvide beynd the state-f-the-art, and the extent the prpsed wrk is ambitius. Yur answer culd refer t the grund-breaking nature f the bjectives, cncepts invlved, issues and prblems t be addressed, and appraches and methds t be used. Describe the innvatin ptential which the prpsal represents n hw this culd translate t the advantage f patients. Where relevant, refer t prducts and services already available n the market. Please refer t the results f any patent search carried ut. IMI2 RIA & IA PROPOSAL TEMPLATE Page 3 f 6

4 2. IMPACT 1 Expected impacts Please be specific, and prvide nly infrmatin that applies t the prpsal and its bjectives. Wherever pssible, use quantified indicatrs and targets. Describe hw yur prject will cntribute t: the expected impacts f the prpsed apprach as indicated in the Call text and in relatin t the prblem statement and bjectives; if relevant describe the expected impact t advance regulatry, clinical and healthcare practice; achieving a greater impact with respect t research and innvatin by cmbining Hrizn 2020 and private sectr funds in a public-private partnership. strengthening the cmpetitiveness and industrial leadership r addressing specific scietal challenges; imprving Eurpean citizens' health and wellbeing and cntribute t the IMI2 JU bjectives; Describe any barriers/bstacles, and any framewrk cnditins (such as regulatin and standards), that may determine whether and t what extent the expected impacts will be achieved. 3. IMPLEMENTATION 3.1 Outline f prject plan Wrk packages, and majr deliverables Please prvide the fllwing: Brief presentatin f the verall structure f the prject plan; Timing f the different wrk packages and their cmpnents (Gantt chart r similar); Brief wrk descriptin, i.e.: a brief descriptin f each wrk package, including apprximate use f the IMI budget; a prpsed list f majr deliverables; the rles and cntributin f the partners; Hw it is envisaged the cllabratin with industrial partners, in particular hw the integratin f their expertise and assets, as described in the call text, will happen in the future public-private cnsrtium which will be established under this tpic. Base yur accunt n the lgical structure f the prject and the stages in which it is t be carried ut. Include preliminary resurce allcatin t each wrk package. The number f wrk packages shuld be prprtinate t the scale and cmplexity f the prject. Yu are advised t include a distinct wrk package n management (see sectin 3.2) and t give due visibility in the prject plan t data management, disseminatin and explitatin and cmmunicatin activities, either with distinct tasks r distinct wrk packages. If relevant cnsider including strategy fr: IMI2 RIA & IA PROPOSAL TEMPLATE Page 4 f 6

5 Definitins: Please refer t submissin system fr the definitive template fr yur call implementatin f the prjects results in the drug develpment, regulatry setting, clinical and healthcare practices and/r decisin making prcesses; interactin with regulatrs/hta bdies (e.g thrugh Qualificatin advice /pinin, etc..) t achieve the uptake f these results; engagement with ther relevant stakehlders (e.g patients, prescribers, payers etc..) that wuld need t be invlved in translatin prcess. Wrk package means a majr sub-divisin f the prpsed prject. Deliverable means a distinct utput f the prject, meaningful in terms f the prject's verall bjectives and cnstituted by a reprt, a dcument, a technical diagram, a sftware etc. These can be further divided int meaningful interim utputs, particularly if the final deliverables are few and can nly be achieved ver several years. 3.2 Management structure and prcedures Outline the rganisatinal, the decisin-making structures and partnership with industry. Explain why the rganisatinal structure and decisin-making mechanisms are apprpriate t the cmplexity and scale f the prject as well as the manageability f the cnsrtium. Describe, where relevant, hw effective innvatin management will be addressed in the management structure and prject plan. Innvatin management is a prcess which requires an understanding f bth market and technical prblems, with a gal f successfully implementing apprpriate creative ideas. A new r imprved prduct, service r prcess is its typical utput. It als allws a cnsrtium t respnd t an external r internal pprtunity. 3.3 Cnsrtium as a whle The individual members f the cnsrtium are described in a separate sectin 4. There is n need t repeat that infrmatin here. Describe the cnsrtium. Hw will it match the prject s bjectives? Hw d the members cmplement ne anther (and cver the value chain, where apprpriate)? In what way des each f them cntribute t the prject? Hw will they be able t wrk effectively tgether? Hw is the partnership with the industry cnsrtium envisaged? 3.4 Table 3.4a: List f wrk packages Wrk package number Wrk Package Title Participants invlved (Shrt Names) Table 3.4b: List f Deliverables Wrk package number Deliverable (number) Deliverable name IMI2 RIA & IA PROPOSAL TEMPLATE Page 5 f 6

6 4. PARTICIPANTS 4.1. Participants (applicants) Please prvide, fr each participant, the fllwing (if available): A brief descriptin f the legal entity and its main tasks, with an explanatin f hw its prfile matches the tasks in the prpsal; A brief curriculum vitae r descriptin f the prfile f the persns, including their gender wh will be primarily respnsible fr carrying ut the prpsed research and/r innvatin activities; A list f up t 5 relevant publicatins, and/r prducts, services (including widely-used datasets r sftware), r ther achievements relevant t the call cntent; A list f up t 5 relevant previus prjects r activities, cnnected t the subject f this prpsal; A brief descriptin f any significant infrastructure and/r any majr items f technical equipment, relevant t the prpsed wrk; Any ther supprting dcuments specified in the IMI2 JU Annual Wrk Plan fr this call. IMI2 RIA & IA PROPOSAL TEMPLATE Page 6 f 6