The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ Fit for Health is funded by the European Commission Legal & financial issues in FP7-Health 6 September ’11 | Virtual Training Martijn de Jager | AgentschapNL Carla Chibidziura | FFG Fit for Health Support to SMEs & Researchers in FP7 Health-oriented projects

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ 6 September ’11 | Virtual Training Two parts: General hints for the HEALTH-2012 call ~ 20 minutes Financial & legal issues ~ 60 minutes Questions: after each part Training material: a record of the virtual training will soon be available at

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ Fit for Health is funded by the European Commission General hints for the HEALTH-2012 call 6 September ’11 | Virtual Training Martijn de Jager | AgentschapNL Fit for Health Support to SMEs & Researchers in FP7 Health-oriented projects

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ What is the 2012-call about? Some keywords: 2-step procedure number of topics contribute to EIP active and healthy ageing medical technologies rare diseases dissemination actions overall expected impact sme-relevant research specific support for clinical trials international cooperation cross-thematic approaches

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ What is the 2012-call about? Some keywords: 2-step procedure number of topics contribute to EIP active and healthy ageing medical technologies rare diseases dissemination actions overall expected impact sme-relevant research specific support for clinical trials international cooperation cross-thematic approaches see workprogramme this part of the training

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ overall expected impact projects will contribute to social innovations in the health sector, this year among others through: support to EIP active and healthy ageing (new technologies, new drugs, new therapies) support to SMEs

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ sme-relevant research (1) What is a sme? less than 250 employees annual turnover ≤ €50 million or balance sheet ≤ €43 million specific rules for autonomy me/facts-figures-analysis/smedefinition/ index_en.htm

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ sme-relevant research (2) SME participation ensures usage of project results  good for societal impact and economic impact in many call topics of the 2012-call ‘Innovation-1’ 15-30% of budget should go to SMEs sometimes asked for ‘leading role’ of SMEs but it can be more…

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ sme-relevant research (3) but it can be more… ‘Innovation-2’ call: large budget (6 million euro) small consortium (3 - 5 partners) short duration (≤ 3 years) large part of budget for SMEs (≥ 50%) SMEs have ‘leading role’ detailed exploitation stage 2

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ sme-relevant research (3) but it can be more… ‘Innovation-2’ call: large budget (6 million euro) small consortium (3 - 5 partners) short duration (≤ 3 years) large part of budget for SMEs (≥ 50%) SMEs have ‘leading role’ detailed exploitation stage 2 tip A leading role does not necessarily mean coordination. But make sure they have a very strong influence!

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ sme-relevant research (3) but it can be more… ‘Innovation-2’ call: large budget (6 million euro) small consortium (3 - 5 partners) short duration (≤ 3 years) large part of budget for SMEs (≥ 50%) SMEs have ‘leading role’ detailed exploitation stage 2 tip SME participation is always a benefit. Even if not asked for explicitly. It is a way to ensure impact. tip A leading role does not necessarily mean coordination. But make sure they have a very strong influence!

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ specific support for clinical trials (1) investigator-driven clinical trials [initiated by academic investigators] topics: optimization of treatment in the elderly paediatric/adolescent diabetes medicines orphan drugs for treatment of rare diseases

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ specific support for clinical trials (1) investigator-driven clinical trials [initiated by academic investigators] topics: optimization of treatment in the elderly paediatric/adolescent diabetes medicines orphan drugs for treatment of rare diseases tip Pay special attention to: - ethical issues - patient involvement - statistics

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ specific support for clinical trials (2) Finance Carried out internally: actual costs or average cost per patient / test / type of test Outsourced to a third party: commercial basis best value for money

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ specific support for clinical trials (2) Finance Carried out internally: actual costs or average cost per patient / test / type of test Outsourced to a third party: commercial basis best value for money warning When outsourced only part of costs will be reimbursed to the project partner by EC

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ international cooperation Basic rule: minimally 3 partners from different member states or associated countries Special cases: SICA: 2 partners MS or AC, 2 partners from international cooperation partner country coordination / support action: 1 or 3 partners Special case for Health call ‘Innovation-1’ call: participants from USA are eligible for funding

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ international cooperation Basic rule: minimally 3 partners from different member states or associated countries Special cases: SICA: 2 partners MS or AC, 2 partners from international cooperation partner country coordination / support action: 1 or 3 partners Special case for Health call ‘Innovation-1’ call: participants from USA are eligible for funding tip Take only the best partners along in your consortium! Excellence, efficiency, and impact are the key!

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ cross-thematic approaches The research part of the EIP active and healthy ageing will be established by the FP7 themes ICT, Health, ‘Food’, and socio-economic sciences. FP7 Health is complemented by several topics from the FP7 themes ICT, ‘Food’, and ‘Nanosciences’.

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ cross-thematic approaches The research part of the EIP active and healthy ageing will be established by the FP7 themes ICT, Health, ‘Food’, and socio-economic sciences. FP7 Health is complemented by several topics from the FP7 themes ICT, ‘Food’, and ‘Nanosciences’. tip Also check the workprogrammes from those themes for possibilities to fund your research.

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ timing Innovation-1 deadline step 1: October 4, 2011 results evaluation: mid December 2011 deadline step 2: February 2012 results evaluation: May 2012 indicative project start: Q Innovation-2 deadline step 1: September 27, 2011 results evaluation: deadline step 2: mid December 2011 results evaluation: February 2012 indicative project start: mid 2012

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ timing Innovation-1 deadline step 1: October 4, 2011 results evaluation: mid December 2011 deadline step 2: February 2012 results evaluation: May 2012 indicative project start: Q Innovation-2 deadline step 1: September 27, 2011 results evaluation: deadline step 2: mid December 2011 results evaluation: February 2012 indicative project start: mid 2012 tip There is not much time between the deadlines. Have your project outline already completely in mind!

The copyright © is owned by the author of this document. Please do not duplicate. Disclaimer: the „Fit for Health project partners do not assume any legal liability or responsibilities for the information provided in this document.“ Martijn de Jager AgentschapNL | find your National Contact Point at: Contact details Thank you!