SlideShare ist ein Scribd-Unternehmen logo
1 von 19
Downloaden Sie, um offline zu lesen
Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.
Governance in DRIVE
Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.
Laurence Torcel-Pagnon – Sanofi Pasteur
on behalf of WP1
DRIVE Annual Forum
17th-18th September 2018, Rome
From IMI Governance to DRIVE adaptation
IMI structure
Public-private
partnership
 Shared decision making
 Co-lead for activities
 Joint contribution
 Transparency of
interactions
 External Independant
advice
 Large participatory forum
DRIVE
Generation of brand specific
Vaccine Effectiveness
 One work package under public
health institutes oversight (studies
conduct)
 Limited EFPIA contribution providing
written comments on studies
through Independent Scientific
committee
 Independent Scientific Committee
responsible for review & approval of
studies documents
 EFPIA part of Quality Control and
Audit Committee to fulfill regulatory
obligations
From IMI structure to DRIVE project
IMI
DRIVE
Steering committee
Composition
50/50 parity between public
consortium and EFPIA
 16 members (work
package leaders and
coordinators)
Composition, members , Role and responsibilities, voting rights
Roles and Responsibilities
 Ensure alignment of activities
between the WPs and progress
towards common goal of success in
the Project
 Review and approve the WP1 to WP6
deliverables
 Recommend and approve changes
(work, budget…) for endorsement by
the General Assembly
 Prepare Project activity reports,
periodic reports, risk management
procedures, quality assurance plans,
prior to submission to the IMI2 JU
 Ensure effective external
communication
Voting rights
Each member has one vote
Decisions will be taken by
75% attending or represented
members
One chairperson = the public
coordinator
Independent Scientific Committee
Composition
Independent external experts
 5 members
 Public coordinator as an
observer
Composition, members , Role and responsibilities
Roles and Responsibilities
 Review WP7 studies
documents (protocol, SAP,
report)
 Receive written feedback
from EFPIA
 Decide on integration of
EFPIA comments or organize
point by point response with
WP7
 Advise on the independence
and transparency of the
scientific review
Compensation
Only travel accomodations
Quality Control and Audit Committee
Composition
Independent external experts
and EFPIA qualified
representatives
 4 members
 Public coordinator as an
observer
Composition, members , Role and responsibilities
Roles and Responsibilities
 Ensure that adequate quality
control in performed on sites
and supervise auditing for
the WP7 studies to allow
EFPIA fulfilling regulatory
obligations
 Develop check list for overall
quality assessment to
improve sites quality of the
data
 Oversight sites audits
conducted by CRO (when
needed)
 Advice on compliance and
conflict of interest
management
Compensation
Only travel accomodations
Independent
Scientific Committee
Hector Izurieta
Liz Miller
Mark Miller
Stefania Salmaso
Marianne van der Sande
Advisory committee members
Quality Control and
Audit committee
Jaime Ballester
Coree Forman
Ann-Marie Kirby
Nathalie Lavis
Workpackage 7
studies
Public health institutes
leadership
Several contributors from
public consortium
Develop generic protocols
Collect sites data
Develop statistical analysis
plan
Perform pooled analysis
Write brand specific influenza
vaccine effectiveness report
Work packages: role and way of working
Workpackages 1 to 6 /8
Guidelines tools framework
Joint public and private
leadership
Several contributors from public
and private consortium
Develop study tools for
improvement
Define framework for brand
specificities
Develop communication plan
Work on governance guidance
and necessary adaptation
Identify research topics for call
for tender
Study platform governance
Quality Control &
Audit Committee
Independent external
experts and vaccine
manufacturers
Independent Scientific
Committee
Scientific oversight
Independent external experts
Work package 7
Studies conduct
Public action
Public
consortium
Steering Committee
Shared decision making
with equal voting rights
50% public-50% vaccine manufacturers
Public
consortium
Vaccine
manufacturers
Public health
professionals and
health providers
Competent
regulatory
authorities
Work package 5
Communication
Joint action
Public
consortium
Vaccine
manufacturers
Public
consortium
Work package
8
Ethics
Joint action
Public
consortium
Vaccine
manufacturers
• Provide yearly robust brand-specific influenza vaccine
effectiveness estimates in Europe, covering different
settings and target populations, communicating the
results to various stakeholders (mainly public health
professionals) and submitting the results to the
regulatory agencies as per EMA guidelines requirements.
Study platform objective
• Study design is carried out by public partners in Work Package
7 (WP7).
• Data collection is carried out at several independently
operating study sites. They remain owners of the data they
collect and are free to perform site analyses and to publicise
their own results.
• New collaborators are selected by the Steering Committee on
a yearly basis through a public call with pre-defined criteria.
• Pan-European pooled analyses are performed by
statisticians and data analysts at P95, a small-medium sized
enterprise.
Way of working
• Study documents (protocols, statistical analyses, reports and
publications) are assessed by the Independent Scientific
Committee (ISC). Vaccine manufacturers provide written
comments on these documents to the ISC. They are not
permitted access to the data or involvement in the conduct of
the studies.
Way of working
• The Quality Control and Audit Committee advises on
compliance and quality of the studies.
• Data quality control and audits are performed, if required,
by a third party on behalf of the vaccine manufacturers to meet
their regulatory requirements.
• Ethics requirements for the study platform are set by public
and private partners in Work Package 8 (WP8).
• A pan-European pooled analysis report is produced at the
end of each season by public partners in WP7, with brand-
specific influenza vaccine effectiveness estimates. This is jointly
submitted by all vaccine manufacturers to competent
authorities to fulfil their regulatory obligations.
Way of working
• Results are presented in scientific meetings and in peer-
reviewed publications by public partners and a summary is
published on the DRIVE website. Public and private partners in
Work Package 5 (WP5) communicate this to public health
professionals and health care providers.
Way of working
• Consortium of 15 partners committed to provide
project outputs to IMI and fulfilling expected
contributions along 5 years
• Research Agenda developed to address knowledge
gaps on influenza vaccine effectiveness
• Identify on what DRIVE should work on
• Develop synergies with other projects/initiatives/groups
• Identify gaps for call for tender
-> DRIVE invites Public health institutes and study sites
capable of researching influenza vaccine effectiveness to
join the network
Expansion of the Consortium
Public health institutes are welcome to join the DRIVE
project at any time to increase the data platform capacity
 Yearly, a public call for tenders is open (Mar–>Aug)
 open to any European organization, institution or network
 aims to fill in identified data gaps (settings, countries, populations,
brands) and to develop novel and innovative approaches
New comers will be invited
to participate in scientific and methodological discussions on studies
(lead by WP7)
to attend the Annual Forum meeting and contribute to the
discussions on innovative and approaches to influenza vaccine
effectiveness (lead by consortium)
Funding is coming from IMI not from Vaccines manufacturers
Governance for new comers
From a prototype to a sustainable platform
• Starting with one governance model (based on
ADVANCE guidelines)
• Yearly evaluation after each season
• collecting insights from DRIVE partners and perceptions from
external stakeholders
• Reviewing efficiency of governance process in place
 governance adaptation when needed implemented for
the next season
• After the 5 years project, propose a sustainable public-
private platform to generate brand specific influenza
vaccine effectiveness data
Governance evaluation and adaptation
Any questions?
www.drive-eu.org
Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.

Weitere ähnliche Inhalte

Was ist angesagt?

International regulatory cooperation: more important than ever
International regulatory cooperation: more important than everInternational regulatory cooperation: more important than ever
International regulatory cooperation: more important than everTGA Australia
 
EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...
EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...
EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...EUnetHTA
 
Drive communication plan and debate - Sharon McHale & Riia Järvenpää
Drive communication plan and debate - Sharon McHale & Riia JärvenpääDrive communication plan and debate - Sharon McHale & Riia Järvenpää
Drive communication plan and debate - Sharon McHale & Riia JärvenpääDRIVE research
 
Creating collaborative systems to address orphan drugs in a sustainable way –...
Creating collaborative systems to address orphan drugs in a sustainable way –...Creating collaborative systems to address orphan drugs in a sustainable way –...
Creating collaborative systems to address orphan drugs in a sustainable way –...Dutch Orphan Drug Network
 
Opening clinical trial data
Opening clinical trial dataOpening clinical trial data
Opening clinical trial dataEFSA EU
 
Evoulution Summit_November_2015_Sundgren
Evoulution Summit_November_2015_SundgrenEvoulution Summit_November_2015_Sundgren
Evoulution Summit_November_2015_SundgrenMats Sundgren
 
DEC 3 2015 Mats Sundgren
DEC 3 2015 Mats SundgrenDEC 3 2015 Mats Sundgren
DEC 3 2015 Mats SundgrenGBX Events
 
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...OECD Environment
 
TGA Presentation: Using the online Clinical Trial Notification (CTN) form
TGA Presentation: Using the online Clinical Trial Notification (CTN) formTGA Presentation: Using the online Clinical Trial Notification (CTN) form
TGA Presentation: Using the online Clinical Trial Notification (CTN) formTGA Australia
 
Data collection by public bodies: joint EFSA - Member State activities
Data collection by public bodies: joint EFSA - Member State activitiesData collection by public bodies: joint EFSA - Member State activities
Data collection by public bodies: joint EFSA - Member State activitiesEFSA EU
 
201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share
201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share
201706 medtech mdr_clinical_evaluation_investigation_ep_slide_shareVoisin Consulting Life Sciences
 
The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...
The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...
The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...HTAi Bilbao 2012
 
Implementation of the International Health Regulations (2005) in the WHO Euro...
Implementation of the International Health Regulations (2005) in the WHO Euro...Implementation of the International Health Regulations (2005) in the WHO Euro...
Implementation of the International Health Regulations (2005) in the WHO Euro...WHO Regional Office for Europe
 
PharmaLedger Press Release #3 December 2020
PharmaLedger Press Release #3 December 2020 PharmaLedger Press Release #3 December 2020
PharmaLedger Press Release #3 December 2020 PharmaLedger
 
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...EUPATI
 

Was ist angesagt? (20)

International regulatory cooperation: more important than ever
International regulatory cooperation: more important than everInternational regulatory cooperation: more important than ever
International regulatory cooperation: more important than ever
 
EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...
EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...
EUnetHTA Training course for Stakeholders - Key principles of Health Technolo...
 
Drive communication plan and debate - Sharon McHale & Riia Järvenpää
Drive communication plan and debate - Sharon McHale & Riia JärvenpääDrive communication plan and debate - Sharon McHale & Riia Järvenpää
Drive communication plan and debate - Sharon McHale & Riia Järvenpää
 
CBA on reference laboratories human pathogens
CBA on reference laboratories human pathogensCBA on reference laboratories human pathogens
CBA on reference laboratories human pathogens
 
Creating collaborative systems to address orphan drugs in a sustainable way –...
Creating collaborative systems to address orphan drugs in a sustainable way –...Creating collaborative systems to address orphan drugs in a sustainable way –...
Creating collaborative systems to address orphan drugs in a sustainable way –...
 
Opening clinical trial data
Opening clinical trial dataOpening clinical trial data
Opening clinical trial data
 
Evoulution Summit_November_2015_Sundgren
Evoulution Summit_November_2015_SundgrenEvoulution Summit_November_2015_Sundgren
Evoulution Summit_November_2015_Sundgren
 
Chapter 3: Putting patients first
Chapter 3: Putting patients firstChapter 3: Putting patients first
Chapter 3: Putting patients first
 
DEC 3 2015 Mats Sundgren
DEC 3 2015 Mats SundgrenDEC 3 2015 Mats Sundgren
DEC 3 2015 Mats Sundgren
 
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...
 
HCF 2017 closing day 2 Jukka Malm
HCF 2017 closing day 2 Jukka MalmHCF 2017 closing day 2 Jukka Malm
HCF 2017 closing day 2 Jukka Malm
 
TGA Presentation: Using the online Clinical Trial Notification (CTN) form
TGA Presentation: Using the online Clinical Trial Notification (CTN) formTGA Presentation: Using the online Clinical Trial Notification (CTN) form
TGA Presentation: Using the online Clinical Trial Notification (CTN) form
 
Data collection by public bodies: joint EFSA - Member State activities
Data collection by public bodies: joint EFSA - Member State activitiesData collection by public bodies: joint EFSA - Member State activities
Data collection by public bodies: joint EFSA - Member State activities
 
201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share
201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share
201706 medtech mdr_clinical_evaluation_investigation_ep_slide_share
 
The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...
The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...
The EUnetHTA Planned and Ongoing Projects Database: Content and Use. Marisa W...
 
Implementation of the International Health Regulations (2005) in the WHO Euro...
Implementation of the International Health Regulations (2005) in the WHO Euro...Implementation of the International Health Regulations (2005) in the WHO Euro...
Implementation of the International Health Regulations (2005) in the WHO Euro...
 
Osp meeting EDCTP
Osp meeting EDCTPOsp meeting EDCTP
Osp meeting EDCTP
 
PharmaLedger Press Release #3 December 2020
PharmaLedger Press Release #3 December 2020 PharmaLedger Press Release #3 December 2020
PharmaLedger Press Release #3 December 2020
 
Health Technology Assessment (HTA): a tool for evidence-informed decision mak...
Health Technology Assessment (HTA): a tool for evidence-informed decision mak...Health Technology Assessment (HTA): a tool for evidence-informed decision mak...
Health Technology Assessment (HTA): a tool for evidence-informed decision mak...
 
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
 

Ähnlich wie Governance in DRIVE - Laurence Torcel-Paignon Sanofi Pasteur

Croi Galway - Derick Mitchell - July 2016
Croi Galway - Derick Mitchell - July 2016Croi Galway - Derick Mitchell - July 2016
Croi Galway - Derick Mitchell - July 2016ipposi
 
APOTECAcommunity paper project review (Feb 2015)
APOTECAcommunity paper project review (Feb 2015)APOTECAcommunity paper project review (Feb 2015)
APOTECAcommunity paper project review (Feb 2015)Loccioni Group
 
WHO international drug monitoring programme.pptx
WHO international drug monitoring programme.pptxWHO international drug monitoring programme.pptx
WHO international drug monitoring programme.pptxashharnomani
 
Evaluating the value of research-by-consortium: Science of Team Science
Evaluating the value of research-by-consortium: Science of Team ScienceEvaluating the value of research-by-consortium: Science of Team Science
Evaluating the value of research-by-consortium: Science of Team ScienceMark David Lim
 
Introduction to the workshop and EUPATI update
Introduction to the workshop and EUPATI updateIntroduction to the workshop and EUPATI update
Introduction to the workshop and EUPATI updateEUPATI
 
Brand specificities and study tools developed by DRIVE
Brand specificities and study tools developed by DRIVE Brand specificities and study tools developed by DRIVE
Brand specificities and study tools developed by DRIVE DRIVE research
 
Connected health data meets the people: Diversity, Standards, and Trust
Connected health data meets the people: Diversity, Standards, and TrustConnected health data meets the people: Diversity, Standards, and Trust
Connected health data meets the people: Diversity, Standards, and Trustchronaki
 
Introduction to DRIVE - Cedric Mahe
Introduction to DRIVE - Cedric MaheIntroduction to DRIVE - Cedric Mahe
Introduction to DRIVE - Cedric MaheDRIVE research
 
Evaluating research consortium
Evaluating research consortiumEvaluating research consortium
Evaluating research consortiumMark David Lim
 
1st eStandards conference: next steps for standardization in large scale eHea...
1st eStandards conference: next steps for standardization in large scale eHea...1st eStandards conference: next steps for standardization in large scale eHea...
1st eStandards conference: next steps for standardization in large scale eHea...chronaki
 
Alpha One Conference - IPPOSI
Alpha One Conference - IPPOSIAlpha One Conference - IPPOSI
Alpha One Conference - IPPOSIipposi
 
Good Clinical Practice Inspections - Consultation to introduce a pilot progra...
Good Clinical Practice Inspections - Consultation to introduce a pilot progra...Good Clinical Practice Inspections - Consultation to introduce a pilot progra...
Good Clinical Practice Inspections - Consultation to introduce a pilot progra...TGA Australia
 
Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014
Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014
Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014Sathish Vemula
 
PROCESS OF ICH (International Council for Harmonisation)
PROCESS OF ICH (International Council for Harmonisation)PROCESS OF ICH (International Council for Harmonisation)
PROCESS OF ICH (International Council for Harmonisation)Swathi P
 

Ähnlich wie Governance in DRIVE - Laurence Torcel-Paignon Sanofi Pasteur (20)

European Clinical Research Infrastructure Network
European Clinical Research Infrastructure NetworkEuropean Clinical Research Infrastructure Network
European Clinical Research Infrastructure Network
 
Croi Galway - Derick Mitchell - July 2016
Croi Galway - Derick Mitchell - July 2016Croi Galway - Derick Mitchell - July 2016
Croi Galway - Derick Mitchell - July 2016
 
APOTECAcommunity paper project review (Feb 2015)
APOTECAcommunity paper project review (Feb 2015)APOTECAcommunity paper project review (Feb 2015)
APOTECAcommunity paper project review (Feb 2015)
 
WHO international drug monitoring programme.pptx
WHO international drug monitoring programme.pptxWHO international drug monitoring programme.pptx
WHO international drug monitoring programme.pptx
 
Evaluating the value of research-by-consortium: Science of Team Science
Evaluating the value of research-by-consortium: Science of Team ScienceEvaluating the value of research-by-consortium: Science of Team Science
Evaluating the value of research-by-consortium: Science of Team Science
 
International council for harmonization by akshay trivedi
International council for harmonization by akshay trivediInternational council for harmonization by akshay trivedi
International council for harmonization by akshay trivedi
 
Introduction to the workshop and EUPATI update
Introduction to the workshop and EUPATI updateIntroduction to the workshop and EUPATI update
Introduction to the workshop and EUPATI update
 
Brand specificities and study tools developed by DRIVE
Brand specificities and study tools developed by DRIVE Brand specificities and study tools developed by DRIVE
Brand specificities and study tools developed by DRIVE
 
Connected health data meets the people: Diversity, Standards, and Trust
Connected health data meets the people: Diversity, Standards, and TrustConnected health data meets the people: Diversity, Standards, and Trust
Connected health data meets the people: Diversity, Standards, and Trust
 
Introduction to DRIVE - Cedric Mahe
Introduction to DRIVE - Cedric MaheIntroduction to DRIVE - Cedric Mahe
Introduction to DRIVE - Cedric Mahe
 
Contribution of a world-class regulatory system to the future of the pharmace...
Contribution of a world-class regulatory system to the future of the pharmace...Contribution of a world-class regulatory system to the future of the pharmace...
Contribution of a world-class regulatory system to the future of the pharmace...
 
Evaluating research consortium
Evaluating research consortiumEvaluating research consortium
Evaluating research consortium
 
ichguidelines-200529100336.pptx
ichguidelines-200529100336.pptxichguidelines-200529100336.pptx
ichguidelines-200529100336.pptx
 
1st eStandards conference: next steps for standardization in large scale eHea...
1st eStandards conference: next steps for standardization in large scale eHea...1st eStandards conference: next steps for standardization in large scale eHea...
1st eStandards conference: next steps for standardization in large scale eHea...
 
Alpha One Conference - IPPOSI
Alpha One Conference - IPPOSIAlpha One Conference - IPPOSI
Alpha One Conference - IPPOSI
 
ICH Guidelines
ICH GuidelinesICH Guidelines
ICH Guidelines
 
Role of ADR monitoring centre
Role of ADR monitoring centreRole of ADR monitoring centre
Role of ADR monitoring centre
 
Good Clinical Practice Inspections - Consultation to introduce a pilot progra...
Good Clinical Practice Inspections - Consultation to introduce a pilot progra...Good Clinical Practice Inspections - Consultation to introduce a pilot progra...
Good Clinical Practice Inspections - Consultation to introduce a pilot progra...
 
Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014
Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014
Pharma Uptoday Monthly Magazine - Volume 6 Issue Sep 2014
 
PROCESS OF ICH (International Council for Harmonisation)
PROCESS OF ICH (International Council for Harmonisation)PROCESS OF ICH (International Council for Harmonisation)
PROCESS OF ICH (International Council for Harmonisation)
 

Mehr von DRIVE research

Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5
Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5
Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5DRIVE research
 
DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...
DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...
DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...DRIVE research
 
DRIVE season 2018/2019
DRIVE season 2018/2019 DRIVE season 2018/2019
DRIVE season 2018/2019 DRIVE research
 
Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...
Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...
Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...DRIVE research
 
The Challenges of Pooling IVE estimates - Jos Nauta, Abbott
The Challenges of Pooling IVE estimates - Jos Nauta, AbbottThe Challenges of Pooling IVE estimates - Jos Nauta, Abbott
The Challenges of Pooling IVE estimates - Jos Nauta, AbbottDRIVE research
 
Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018
Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018
Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018DRIVE research
 
Getting involved in DRIVE - Topi Turunen FISABIO
Getting involved in DRIVE - Topi Turunen FISABIOGetting involved in DRIVE - Topi Turunen FISABIO
Getting involved in DRIVE - Topi Turunen FISABIODRIVE research
 
Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95
Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95
Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95DRIVE research
 
Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDC
Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDCInfluenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDC
Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDCDRIVE research
 
Regulatory requirements for influenza vaccines - Marco Cavaleri EMA
Regulatory requirements for influenza vaccines - Marco Cavaleri EMARegulatory requirements for influenza vaccines - Marco Cavaleri EMA
Regulatory requirements for influenza vaccines - Marco Cavaleri EMADRIVE research
 

Mehr von DRIVE research (10)

Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5
Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5
Dissemination of Pilot Year Outcomes - Communications Workshop, Work Package 5
 
DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...
DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...
DRIVE CENTRAL STUDY PLATFORM: Data flow, data quality and statistical analysi...
 
DRIVE season 2018/2019
DRIVE season 2018/2019 DRIVE season 2018/2019
DRIVE season 2018/2019
 
Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...
Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...
Roundtable discussion: Relevance of the DRIVE study platform and sustainabili...
 
The Challenges of Pooling IVE estimates - Jos Nauta, Abbott
The Challenges of Pooling IVE estimates - Jos Nauta, AbbottThe Challenges of Pooling IVE estimates - Jos Nauta, Abbott
The Challenges of Pooling IVE estimates - Jos Nauta, Abbott
 
Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018
Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018
Previous exposure to natural infection matters, Ulrike Baum - ESCAIDE 2018
 
Getting involved in DRIVE - Topi Turunen FISABIO
Getting involved in DRIVE - Topi Turunen FISABIOGetting involved in DRIVE - Topi Turunen FISABIO
Getting involved in DRIVE - Topi Turunen FISABIO
 
Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95
Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95
Novel and innovative approaches for measuring influenza VE - Anke Stuurman P95
 
Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDC
Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDCInfluenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDC
Influenza vaccine effectiveness studies in Europe - Pasi Penttinen ECDC
 
Regulatory requirements for influenza vaccines - Marco Cavaleri EMA
Regulatory requirements for influenza vaccines - Marco Cavaleri EMARegulatory requirements for influenza vaccines - Marco Cavaleri EMA
Regulatory requirements for influenza vaccines - Marco Cavaleri EMA
 

Kürzlich hochgeladen

Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisSujoy Dasgupta
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismusChandrasekar Reddy
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationMedicoseAcademics
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsMedicoseAcademics
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.aarjukhadka22
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondSujoy Dasgupta
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologyDeepakDaniel9
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfHongBiThi1
 
historyofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusanguhistoryofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusangu Medical University
 
MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.whalesdesign
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024EwoutSteyerberg1
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentsaileshpanda05
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE Mamatha Lakka
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdfHongBiThi1
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyMedicoseAcademics
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfMedicoseAcademics
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communicationskatiequigley33
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdfHongBiThi1
 

Kürzlich hochgeladen (20)

Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosis
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismus
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functions
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and Beyond
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacology
 
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
 
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdfSGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
SGK LEUKEMIA KINH DÒNG BẠCH CÂU HẠT HAY.pdf
 
historyofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusanguhistoryofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusangu
 
MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing student
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before Pregnancy
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdf
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communications
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
 

Governance in DRIVE - Laurence Torcel-Paignon Sanofi Pasteur

  • 1. Acknowledgement DRIVE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777363, This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Governance in DRIVE Acknowledgement DRIVE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777363, This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Laurence Torcel-Pagnon – Sanofi Pasteur on behalf of WP1 DRIVE Annual Forum 17th-18th September 2018, Rome
  • 2. From IMI Governance to DRIVE adaptation IMI structure Public-private partnership  Shared decision making  Co-lead for activities  Joint contribution  Transparency of interactions  External Independant advice  Large participatory forum DRIVE Generation of brand specific Vaccine Effectiveness  One work package under public health institutes oversight (studies conduct)  Limited EFPIA contribution providing written comments on studies through Independent Scientific committee  Independent Scientific Committee responsible for review & approval of studies documents  EFPIA part of Quality Control and Audit Committee to fulfill regulatory obligations
  • 3. From IMI structure to DRIVE project IMI DRIVE
  • 4. Steering committee Composition 50/50 parity between public consortium and EFPIA  16 members (work package leaders and coordinators) Composition, members , Role and responsibilities, voting rights Roles and Responsibilities  Ensure alignment of activities between the WPs and progress towards common goal of success in the Project  Review and approve the WP1 to WP6 deliverables  Recommend and approve changes (work, budget…) for endorsement by the General Assembly  Prepare Project activity reports, periodic reports, risk management procedures, quality assurance plans, prior to submission to the IMI2 JU  Ensure effective external communication Voting rights Each member has one vote Decisions will be taken by 75% attending or represented members One chairperson = the public coordinator
  • 5. Independent Scientific Committee Composition Independent external experts  5 members  Public coordinator as an observer Composition, members , Role and responsibilities Roles and Responsibilities  Review WP7 studies documents (protocol, SAP, report)  Receive written feedback from EFPIA  Decide on integration of EFPIA comments or organize point by point response with WP7  Advise on the independence and transparency of the scientific review Compensation Only travel accomodations
  • 6. Quality Control and Audit Committee Composition Independent external experts and EFPIA qualified representatives  4 members  Public coordinator as an observer Composition, members , Role and responsibilities Roles and Responsibilities  Ensure that adequate quality control in performed on sites and supervise auditing for the WP7 studies to allow EFPIA fulfilling regulatory obligations  Develop check list for overall quality assessment to improve sites quality of the data  Oversight sites audits conducted by CRO (when needed)  Advice on compliance and conflict of interest management Compensation Only travel accomodations
  • 7. Independent Scientific Committee Hector Izurieta Liz Miller Mark Miller Stefania Salmaso Marianne van der Sande Advisory committee members Quality Control and Audit committee Jaime Ballester Coree Forman Ann-Marie Kirby Nathalie Lavis
  • 8. Workpackage 7 studies Public health institutes leadership Several contributors from public consortium Develop generic protocols Collect sites data Develop statistical analysis plan Perform pooled analysis Write brand specific influenza vaccine effectiveness report Work packages: role and way of working Workpackages 1 to 6 /8 Guidelines tools framework Joint public and private leadership Several contributors from public and private consortium Develop study tools for improvement Define framework for brand specificities Develop communication plan Work on governance guidance and necessary adaptation Identify research topics for call for tender
  • 9. Study platform governance Quality Control & Audit Committee Independent external experts and vaccine manufacturers Independent Scientific Committee Scientific oversight Independent external experts Work package 7 Studies conduct Public action Public consortium Steering Committee Shared decision making with equal voting rights 50% public-50% vaccine manufacturers Public consortium Vaccine manufacturers Public health professionals and health providers Competent regulatory authorities Work package 5 Communication Joint action Public consortium Vaccine manufacturers Public consortium Work package 8 Ethics Joint action Public consortium Vaccine manufacturers
  • 10. • Provide yearly robust brand-specific influenza vaccine effectiveness estimates in Europe, covering different settings and target populations, communicating the results to various stakeholders (mainly public health professionals) and submitting the results to the regulatory agencies as per EMA guidelines requirements. Study platform objective
  • 11. • Study design is carried out by public partners in Work Package 7 (WP7). • Data collection is carried out at several independently operating study sites. They remain owners of the data they collect and are free to perform site analyses and to publicise their own results. • New collaborators are selected by the Steering Committee on a yearly basis through a public call with pre-defined criteria. • Pan-European pooled analyses are performed by statisticians and data analysts at P95, a small-medium sized enterprise. Way of working
  • 12. • Study documents (protocols, statistical analyses, reports and publications) are assessed by the Independent Scientific Committee (ISC). Vaccine manufacturers provide written comments on these documents to the ISC. They are not permitted access to the data or involvement in the conduct of the studies. Way of working
  • 13. • The Quality Control and Audit Committee advises on compliance and quality of the studies. • Data quality control and audits are performed, if required, by a third party on behalf of the vaccine manufacturers to meet their regulatory requirements. • Ethics requirements for the study platform are set by public and private partners in Work Package 8 (WP8). • A pan-European pooled analysis report is produced at the end of each season by public partners in WP7, with brand- specific influenza vaccine effectiveness estimates. This is jointly submitted by all vaccine manufacturers to competent authorities to fulfil their regulatory obligations. Way of working
  • 14. • Results are presented in scientific meetings and in peer- reviewed publications by public partners and a summary is published on the DRIVE website. Public and private partners in Work Package 5 (WP5) communicate this to public health professionals and health care providers. Way of working
  • 15. • Consortium of 15 partners committed to provide project outputs to IMI and fulfilling expected contributions along 5 years • Research Agenda developed to address knowledge gaps on influenza vaccine effectiveness • Identify on what DRIVE should work on • Develop synergies with other projects/initiatives/groups • Identify gaps for call for tender -> DRIVE invites Public health institutes and study sites capable of researching influenza vaccine effectiveness to join the network Expansion of the Consortium
  • 16. Public health institutes are welcome to join the DRIVE project at any time to increase the data platform capacity  Yearly, a public call for tenders is open (Mar–>Aug)  open to any European organization, institution or network  aims to fill in identified data gaps (settings, countries, populations, brands) and to develop novel and innovative approaches New comers will be invited to participate in scientific and methodological discussions on studies (lead by WP7) to attend the Annual Forum meeting and contribute to the discussions on innovative and approaches to influenza vaccine effectiveness (lead by consortium) Funding is coming from IMI not from Vaccines manufacturers Governance for new comers
  • 17. From a prototype to a sustainable platform • Starting with one governance model (based on ADVANCE guidelines) • Yearly evaluation after each season • collecting insights from DRIVE partners and perceptions from external stakeholders • Reviewing efficiency of governance process in place  governance adaptation when needed implemented for the next season • After the 5 years project, propose a sustainable public- private platform to generate brand specific influenza vaccine effectiveness data Governance evaluation and adaptation
  • 19. www.drive-eu.org Acknowledgement DRIVE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777363, This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.