Information & Preparatory Event EU-India Call Next Generation Influenza Vaccine to protect citizens worldwide

Information & Preparatory Event
                         EU-India Call
             Next Generation Influenza Vaccine to
                  protect citizens worldwide
                         New Delhi, 28 August 2018

Guidelines for Participation – eligibility, funding modalities
                and application procedure

Ms Tania FRIEDRICHS, Head, R&I Section, EU Delegation to India
Dr Vivek DHAM, R&I Section, EU Delegation to India
Dr Shailja GUPTA, Advisor, Department of Biotechnology, India
Dr Amit P. PARIKH, Department of Biotechnology, India

OUTLINE
1.     WHERE TO FIND CALL TEXT?
2.     WHO CAN PARTICIPATE?
3.     CONSORTIUM FORMATION
     ↗ HOW TO FIND PARTNERS FOR A CONSORTIUM?
     ↗ ROLE: PROJECT COORDINATOR & LEAD SCIENTIFIC COORDINATOR
     ↗GENDER
4.     PROPOSAL PREPARATION
     ↗REGISTRATION OF APPLICANTS ON THE EC PARTICIPANT PORTAL
     ↗FUNDING RATES
5.     STRUCTURE OF THE PROPOSAL
     ↗ADMINISTRATIVE & FINANCIAL PARTS (PART A)
     ↗RESEARCH PROPOSAL (PART B)
6.     SUBMISSION OF PROPOSAL
7.      TIME LINE
8.     EVALUATION

WHERE TO FIND CALL TEXT?

•     EC – HORIZON 20202 : PARTICIPANT PORTAL
    ↗http://ec.europa.eu/research/participants/portal/desktop/en/opportuniti
     es/h2020/topics/sc1-bhc-32-2019.html
•    IND –DBT: CALL FOR PROPOSALS
    ↗http://www.dbtindia.nic.in/india-eu-research-and-innovation-action/

FIND OUT IF YOU’RE ELIGIBLE TO APPLY
                                             INDIA
• Public or Private: academia, research organisations and urban or other local bodies
   – Public and/or private universities and research organisations must have a well-established
     research support system, for basic or applied research; and
   – Submission of proof of establishment under Indian statue; recognition documents and
     registration at Government of India's Public Finance Management System (PFMS) -
     https://pfms.nic.in shall be obligatory
• Not-for-profit, NGO(s)/ VO(s)/ Trust(s)/ Research Foundations:
   – should have experience of at least 3 years in scientific research, teaching, training and extension
     activities; and
   – Proof of registration at ‘NGO DARPAN’ of NITI Aayog; Certificate of registration under Society
     Registration Act; certificate of DSIR in-house R&D recognition and registration at Government of
     India's Public Finance Management System (PFMS) shall be obligatory;
• Industry
   – Should be an Indian Company registered under the Companies Act, wherein 51% (or more) of the
     ownership/shareholding/partnerships shall be held by resident Indian citizen(s); and
   – Submission of certificate of incorporation issued under Companies Act; Shareholding/ subscriber
     Particulars; certificate of DSIR in-house R&D recognition and registration at Government of
     India's Public Finance Management System (PFMS) shall be obligatory.

FIND OUT IF YOU’RE ELIGIBLE TO APPLY
                        EUROPEAN UNION

• Any legal entity: company, big or small, research organisations,
  universities, non-governmental organisations, regardless of their place
  of residence or establishment in "Europe";

• They must possess the operational and financial viability to carry out
  the research tasks that they propose.

 • Applicants from non-European countries are also eligible to
   participate subject to Horizon 2020 rules of participation and
   funding – OPEN TO THE WORLD

MINIMUM REQUIREMENT FOR PARTICIPATION

                                           Mandatory
• INDIA: At least THREE different legal organisations from India
  with expertise in relevant and distinct disciplines. All three legal
  entities shall be independent of each other
                                AND
• EU: At least THREE legal organisations from Europe: Each of the
  three shall be established in a DIFFERENT Member State (28) or
  Horizon 2020 Associated Countries (16). All three legal entities
  shall be independent of each other.

Entities from UK: see Participant Portal
http://ec.europa.eu/research/participants/portal/desktop/en/support/about.html

As of 1 May 2018, the following countries are associated to Horizon 2020: Iceland,
Norway, Albania, Bosnia and Herzegovina, the former Yugoslav Republic of Macedonia,
Montenegro, Serbia, Turkey, Israel, Moldova, Switzerland, Faroe Islands, Ukraine, Tunisia,
Georgia, Armenia.

OPTIONAL PARTICIPATION

• Additional partners from India and Europe: as required for the
  execution of the project.
• Any      organisation       from      non-European      country
  (developed/industrial and developing countries) – in accordance
  with specific Horizon 2020 funding rules.

CONSORTIUM FORMATION
• At least 3 different legal organisations from India and 3 legal
  organisations from three different EU Member States and/or
  Associated Countries;
• Additional legal organisations depending on project requirement
  from India, Europe and other non-European countries could be
  included;
• Partners: multidisciplinary,    cross-sectoral    and   cross-border
  participation encouraged;
• Gender balance: female participation highly encouraged;
• One Project Coordinator – consortium to decide;
• One lead scientific coordinator from India.

ROLE IN CONSORTIUM
                                                Coordinator
                  ROLES                Lead scientifique coordinator
                                                  Partner

• Project Coordinator: the coordinator leads and represents all
  applicants. He or she acts as the point of contact with the
  Commission - consortium to decide.
           o Requires experience
           o Some more resources
           o Ability to manage the project
           o A clear strategy in every aspect
           o Knowledge of Horizon 2020 modalities
           o A strong network of partners

• Lead scientific coordinator: to be selected among Indian
  applicants. Needs good understanding of DBT regulations and
  experience in ethical and pre-clinical procedures of Govt. of India.

GET HELP TO FIND A PROJECT PARTNER

You will need to form a consortium with partners from other
countries.
Tools to help in finding partners:
•   Expressed Interest: H2020 – Participant Portal
•   European Commission Participation Portal partner search tool
•   European Commission CORDIS partner search tool
•   National Contact Points in Europe
•   Enterprise Europe Network
•   Knowledge Transfer Network
•   Horizon 2020 Health Partnering Day 2018, 3 to 4 September
    2018, Oslo, Norway

PROPOSAL PREPARATION

                      Minimum THREE applicants from India and minimum THREE
Eligible Applicant(s) applicants from Europe (from three different Member
                      States/Associated Countries)

     Types of action Research and Innovation Action (RIA)
    Deadline Model Single-stage
           Opening 26 July 2018

Submission deadline 16 April 2019- 17h00 - Central European Time (CET)

    Project Duration Up to Five years
                  Estimated between EUR 6 to 10 million per project from European
                  side and matched by funding from DBT covering Indian applicants.
    Award Amounts Nonetheless, this does not preclude submission and selection of
                  proposals requesting other amounts.

STRUCTURE OF PROPOSAL

ADMINISTRATIVE &FINANCIALPARTS (PART A)   RESEARCH PROPOSAL (PART B)

PART A: ADMINISTRATIVE FORMS (1)
A1: General Information:
↗Project Title
↗Acronym
↗Keywords
↗Abstract
↗Declarations

A2:Administrative data of all participating organisations
↗All beneficiary organisations need to have a valid PIC number
↗Contact person(s) for each organisation should be added

 Part A to be completed online

PART A: ADMINISTRATIVE FORMS (2)
A3: Budget
↗Budget per beneficiary
↗Indirect costs are calculated automatically

A4: Ethics Issues

  Part A to be completed online

PART B – RESEARCH PROPOSAL

1. Excellence
2. Impact
3. Quality and Efficiency of the implementation
4. Members of the Consortium
5. Ethics and Security issues

Part B (narrative part, Word template) – to be uploaded as Annex 1

PART B – RESEARCH PROPOSAL

                        1 - Excellence
1.1 Objectives =>Clear, pertinent and measurable objectives,
credibility of the scientific approach…
1.2 Relation to the work programme => addressing the call
challenge and scope
1.3 Concept and Methodology => novel approach, addresses
challenges from the call, beyond the state-of-the-art, description of
the methodology + cross-cutting issues
1.4 Ambition => Ground-breaking nature of the objectives, concept,
multi-disciplinarily considered, innovation potential…

PART B – RESEARCH PROPOSAL

                               2 - Impact
2.1 Expected impact => impact indication can be found in Work programme
and specific call text;
=> Enhancing innovation capacity and integration of new knowledge
=> Strengthening the competitiveness and growth of companies by
developing innovations and addressing global health challenge
2.2 Measures to maximize impact
a) Dissemination and exploitation (provide a draft plan for the dissemination
and exploitation of the project´s results); open research data/publication;
outline of knowledge management and protection (incl. measures to provide
open access, IPR…)
b) Communication activities (target groups and measures)

PART B – RESEARCH PROPOSAL

                       3 - Implementation
3.1 Work plan - Work packages, deliverables => overall structure of the project,
coherent and effective work plan, description of the Work package and tasks, list
of deliverables incl. appropriate of the allocation of tasks and resources
3.2 Management structure, milestones and procedures incl. critical risk and
mitigation measures, appropriate management structure
3.3. Consortium as a whole => description of the consortium, involvement of
industrial/commercial participants, involvement of other countries.
3.4 Resources to be committed => completed financial tables (per Work
Package), justification of the “other direct costs” items for each participant
(=only if the total exceeds 15% of personnel costs for that participant)

Page limit: For full proposals, the cover page, and sections 1, 2 and 3, together
should not be more than 70 pages.

PART B – RESEARCH PROPOSAL
                4 - Members of the Consortium
• => no page limit
• 4.1 Participants => short description of the participants incl.
  their expertise, involvement in tasks, short CVs, list of 5 relevant
  publications, list of 5 relevant projects
• 4.2. Third parties involved
                    5 - Ethic and Security
• => no page limit
• 5.1 Ethics => to be completed very carefully. Depending on
  research to be carried out, submission of the ethic self-
  assessment document as well as other necessary documents may
  be requested in the application.
• 5.2. Security => reply to the questions listed.

PREPARATION OF BUDGET (1)

                FUNDING PER PROJECT

 EU contribution between EUR 6 and 10 million per
  project
 Indian contribution as per requirement of project
  execution
 Funding for duration of project: up to five years.
 Budget sharing: as per the project proposal-to be
  decided by consortium

PREPARATION OF BUDGET (2)

                       DBT – FUNDING RATE
DBT support (Grant-in-aid) 100% of the approved budget to :
I.     Govt. of India supported or recognised public or private
       academic institutions or research organisation, and urban or
       other local bodies;
II. Not-for-profit,   NGO(s)/    VO(s)/   Trust(s)/Research
    foundations, having research as one of the imperative
    mandates .
DBT support Grant-in-aid to Industry up to 50%
III.      DBT's Grant-in-aid will not exceed 50% of the total project
          cost and the remaining 50% contribution shall
          mandatorily come from the Industry

PREPARATION OF BUDGET (3)

      DBT – ELIGIBLE COST FOR PUBLIC/PRIVATE/NGO
                    100% reimbursement of direct costs
            indirect costs /overhead charges: as per DBT norms
• Capital expenditure (equipment's)
• Manpower
• Consumables
• Travel (local and international travel)
• Contingency
• Overheads
• Outsourcing
Academia can factor in additional sub heads:
• Training & awareness
• Workshops
• Publications
• Review meetings

PREPARATION OF BUDGET (4)

             DBT –COST FOR INDIAN INDUSTRY

The cost breakup for the DBT component (50%) shall be:

• Capital costs not exceeding 30% of the project cost;
• Manpower costs not exceeding 30% of the project cost;
• Balance will cover consumables and travel costs.

• Contingency & overhead costs will not be permissible for Indian
  Industry.

PREPARATION OF BUDGET (5)

                     DBT – INELIGIBLE COST

• Civil Construction costs;
• Prosecution/litigation costs;
• Salary of investigators.

PREPARATION OF BUDGET (6)

         EUROPEAN COMMISSION (EC)
    RESEARCH & INNOVATION ACTION- RIA
FUNDING RATE: APPLICABLE TO ALL EUROPEAN ENTITIES

     100% direct costs + 25% indirect costs

PREPARATION OF BUDGET (7)

     EC- H2020 –COST

SUBMISSION PROCEDURE
                      STEP 1- LOGIN ECAS
European Commission Authentication Service (ECAS)

An ECAS account is needed to login to the Participation Portal and other European
Commission websites and online services. An ECAS account can be created here
            (1 ECAS account = 1 e-mail address = 1 person)

STEP 2 - PIC
Participant Identification Code (PIC), needed for all participants in H2020 projects. This is
9 digits unique identifier of your organisation and will be used as a reference by the
Commission in any interactions. More information can be found here (link is external).

HOW TO OBTAIN A PIC: REGISTER YOUR ORGANISATION

•   As soon as you have your ECAS Account you can login to the Participant Portal and
    register your organisation.
•   You can find the process on a step by step guide on Participant Portal (click here)
•   Supporting documents for registration: before you start you should have copies of the
    following documents ready:
           • Copies of the certificate on the state registration (for private organisations),
             law/decree (for public entities), Treaty (for international organisations)
           • VAT/GST Extract (if applicable)
           • Copies of Statutes (if entity declares non-profit status) etc.
•   In large organisations with multiple departments belonging to the same organisation (a
    single legal entity), units or departments cannot participate as separate entities in H2020
    projects. Therefore, all departments must use the same PIC that is assigned to the
    organisation being the legal entity.
•   At the end of your registration the system will give you a Number called PIC (Participant
    Identification Code). You can use this number only 48 hours after the registration, so
    make sure you finish the process in advance.

SUBMISSION PROCEDURE
Start submission
Go to :
http://ec.europa.eu/research/participants/portal/d
esktop/en/opportunities/h2020/topics/sc1-bhc-32-
2019.html

BUDGET SUBMISSION (1)

ADMINISTRATIVE &FINANCIALPARTS (PART A)   RESEARCH PROPOSAL (PART B)

BUDGET SUBMISSION
        PART A: ADMINISTRATIVE FORMS (2)
A3: Budget in EUR
↗ Each participant (Europe and Indian) to indicate cost of their action in EUR
↗ Note: Indian Partner need NOT to fill in requested budget from the EC
↗ The total budget corresponds to the total cost of the project (not the
 requested costs from EC budget)
↗Ineligible costs such as deductible VAT/GST, losses due to fluctuation of
 exchange rates, interest owed, provisions for future losses or debts are not
 reimbursed

  Part A to be completed online

BUDGET SUBMISSION
          PART B: RESEARCH PROPOSAL (3)
Annex 2a: additional budget details in INR

BUDGET SUBMISSION
           PART B: RESEARCH PROPOSAL (3)
Annex 2 a: additional Budget Details
• Indian participants MUST provide detailed financial plan in INR and
 upload in Part B- Annex 2a of proposal.

• To be noted: information to be provided in specific form according to
 Template provided by DBT http://www.dbtindia.nic.in/wp-
 content/uploads/Template-for-Indian-Requirements.docx

MONEY FLOW

   EU                          IND
                               DBT

Coordinator
                 Consortium
                Agreement to
               define when /
                               Partners
   Partners        how much.

REGULATORY AND ETHICAL CONSIDERATIONS
                INDIA
↗ Research using hazardous microorganisms, genetically engineered (GE)
 organisms & products thereof for R&D purpose
↗National Ethical Guidelines for Biomedical and Health Research Involving
 Human Participants, 2017
 http://www.icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf
↗ Authorizations for pre-clinical and/or human clinical trials
↗Clinical Trials Registry of India (CTRI) – India
 http://ctri.nic.in/Clinicaltrials/login.php

India PIs of the consortium should apply to their institutional review
boards (IRBs)/ institutional ethics committees (IECs) at the time of
submission of proposal to obtain necessary bioethics approvals from all
involved institutions. If selected, Indian PIs are required to submit proof of
their institution’s IRB/IECs approval to DBT by no later than
                          30 November 2019

CHECK LIST
1. Submitted in the electronic submission system by deadline 16 April 2019
   17h00 CET  Acknowledgement of Receipt

2. Complete (requested administrative forms + proposal description + supporting
   documents)
3. Readable, accessible and printable
4. Respecting page limit (RIA: 70 pages)
   o   Outside 70 page limit:
       ‒ Indian budget forms (annex 2a)
       ‒ participating organisations (operational capacity check)
       ‒ CV or profile description of staff carrying out the work
       ‒ A list of up to 5 publications and/or other research or innovation products.
       ‒ A list of up to 5 relevant previous projects/activities
       ‒ Relevant available infrastructure/equipment
       ‒ Description of additional third parties contributing to the work
       − ethics self assessment, data management plan (open access to peer-reviewed
         scientific publications)

SUBMISSION OF PROPOSAL TO DBT

• The Lead Scientific Coordinator from India must submit the
 complete proposal, Part A + Part B + administrative and financial
 form (same as submitted on the Horizon 2020 Participant Portal) as
 a single consolidated PDF file, by 19 April 2019 to

                 email ID: icone@dbt.nic.in
• Make sure Indian Budget & Financial Activities with justification are
 included!
• Please note that the proposal will be disqualified, if not submitted
 to above email ID by indicated date to DBT
• Any discrepancy found in the proposal submitted to Horizon 2020
 Participant Portal compared to DBT will be disqualified.

Time Line
                                                                June 2019: Ethics screening
16 April 2019: Closing of Call
                                                                July – August 2019 Inform applicants
                   Remote evaluations –        Central evaluations                               December 2019
                    May -June 2019              June – July 2019                                  GAP ending

Receipt of            Individual          Consensus          Panel           Finalisation              GAP
proposals             evaluation            group            Review

   Eligibility           Individual        Consensus       Panel report      Final ranked list        All Grant
     check               Evaluation          Report                                                  Agreements
                          Reports                          Evaluation            Evaluation            signed
 Allocation of                                           Summary Report        results sent to
 proposals to             (done                                                  applicants
 evaluators             remotely)                         Cross-readings
                                                                              Initiation Grant
                                                         Panel ranked list      Agreement
                                                                                Preparation

                    Time-To-Inform (TTI): 5 months

                             Time-To-Grant (TTG): 8 months

EVALUATION

 Excellence, transparency, fairness, impartiality,
  efficiency and speed
 Done by independent experts
   o Balance in terms of
        1. Skills, experience and knowledge
        2. Other factors
− geographical diversity
− gender
− where appropriate, the private and public sectors
− an appropriate turnover from year to year

   o No conflict of interest !

Thank you!
    #InvestEUresearch
www.ec.europa.eu/research
  Participant Portal www