SlideShare a Scribd company logo
The tripartite dimension of
interaction of patients,
regulators and industry
Setting the scene and objectives for the day
Jan Geissler & the EUPATI team
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed of financial contribution from the
European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
Better medicines for patients:
The tripartite interaction
Patients
Industry
and
Academia
Regulators
Patient involvement requires systematic
interaction of all stakeholders
 It is acknowledged* that patients’ contribution to the discovery,
development and evaluation of medicines enriches
• quality of research and development
• quality of evidence and opinion
• transparency, trust and mutual respect.
 Close cooperation and partnership between
the various stakeholders
• pharmaceutical industry,
• regulatory authorities and
health technology assessment (HTA) bodies,
• patients’ and consumers’ organisations,
• healthcare professionals’ organisations,
• academia, scientific and academic societies.
Patients
Industry and
Academia
Regulators
* Adapted from EMA Framework
Practical roadmap on
Patient Involvement in Research and Development (R&D)
Development design
and Planning
Design of Protocol
Informed Consent Study reporting
Post-study
communication
Patient Info
Leaflet
Trial steering committee
Investigators Meeting
Level of expertise in the disease area required:
mediumhigh
Data Monitoring CommitteePractical
considerations
Health Technology
Assessment
Protocol
Synopsis
Research
priorities
Setting
research
priorities:
Information to
Clinical Trial trial
participants
Development conduct and
operations
Regulatory affairs
Dissemination,
communication,
post-approval
Source: Geissler, Ryll, Leto, Uhlenhopp
EPALCO/EUPATI (2015, unpublished)
Fundraising
for research
Ethics Review
EUPATI Fellows are increasingly engaging
with industry, regulators and HTA
Involvement of our EUPATI Fellows before and after the Patient Expert Training Course
Role Before EUPATI After
Member of patient organisation, not actively involved 20% 0%
Active role in a patient organisation 60% 72%
Leadership role in a patient organisation 52% 72%
Employee of a patient organisation 20% 20%
Volunteer role in a patient organisation 68% 84%
Presenting at conferences, workshops etc. 44% 72%
Advising a pharmaceutical company 8% 52%
Advising a regulatory agency 12% 40%
Advising a reimbursement agency 4% 8%
Source: EUPATI Course 1 fellow survey, June 2016, N=25
The interaction still has challenges
 Cultivating our own garden, and lack of mutual learning
(across/between industry, regulators, patient organisations)
 Perceived or real legal barriers and conflict of interest
 Silo-thinking and finger-pointing, leading to mushrooming of
individual, non-consolidated processes, rules and codes
 Lack of standardised metrics to measure benefits and impact
 Lack of trust (amongst agencies, industry, patient organisations,
politicians, lay audience, press), absorbing energy, time and
motivation
 Lack of capacity in patient organisations,
lack of “universal patient experts in R&D”
EUPATI has impact and has come with
positive side effects, sustainability is key
 5 years ago, EUPATI was formed to develop training material and run
the Patient Expert Training Course
 The “EUPATI boat” navigated safely through some stormy seas
 EUPATI comes with positive side effects:
• Many patients and their organisations have greatly improved on their
collaboration with industry, or initiated interaction at levels not seen before
• NCA & EMA initiated or increased new collaborations and improved existing
ones. Trained patient experts knock at their doors & look for opportunities to provide
input
• HTA: Slow processes under national jurisdiction – some encouraging
developments, and more patients trained on HTA methodologies than ever before
• Ethics: Very disparate processes at national level, but increasing opportunities for
patients. Increasing awareness of value of patient involvement in ethics committees
 To date, rather little interest by public sponsors to support this
movement, even though patients act in the interest of society!
 EUPATI long-term sustainability is of major public health interest.
EUPATI will continue!
 EUPATI is the only dedicated training
institution and trusted brand on
patient involvement in medicines
R&D.
 EUPATI is hugely successful
• ~100 EUPATI Fellows
• >32.500 unique users of the Toolbox
• >16 national EUPATI platforms
 The current IMI1 funding will end in
January 2017
 EUPATI will continue as an EPF-led
tripartite programme to harvest the
fruits
 During the “bridging phase”, EUPATI
will focus on exploitation of Toolbox
and will keep content up to date.
Let’s go! Objectives for today
 Share views, experience and learnings in pilot projects and
evolution of processes of regulators, industry and patients,
building on our 2014 workshop
 Help ensure that the tripartite interaction is understood,
respected and trusted by all stakeholders and the public at large.
 Regulatory work stream:
• Learn from pilot projects and regular/systematic involvement of patients both on
EU and NCA level
• Support interaction of regulators with patients
 Industry work stream:
• Discuss progress on evolution of industry processes to involve patients in all
aspects of medicines R&D (e.g. clinical development plans, clinical trial design and
conduct, compliance processes, patient information)
• Encourage patient involvement earlier in a more meaningful, systematic manner
Today’s agenda
Setting the scene – patients, regulators and industry perspective
Parallel work stream:
INDUSTRY
How industry processes and “actual
implementation” has changed to involve
patients in R&D: Cases and discussion
Parallel work stream:
REGULATORS
Sharing how EMA and NCAs approach
and/or implement patient involvement in
regulatory authorities’ processes:
Cases and discussion
10:00
11:30
14:30
Discussion
How does that all fit together? Risks, independence, mishaps,
educational needs, guidance documents
16:00
Report from the two work streams
15:00
(12:30
Lunch)
How does this all fit together?
Intended outcome when we part today.
 Clear overview of regulators’, industry and patients’ respective
viewpoints.
 Shared experience and learnings of pilot projects and evolution of
processes within regulatory and industry.
 Discussed challenges and bottlenecks around potential conflicts of
interest in collaboration within the ‘triangle’ of patient organisations,
regulators and industry.
 Developed collaborative solutions and safeguards to drive and
nurture the collaboration.
 Provided input into EUPATI guidance documents on interaction of
patients/organisations with regulators, HTA, industry, ethics committees
Let’s go!

More Related Content

What's hot

Patients’ voice in access decisions
Patients’ voice in access decisionsPatients’ voice in access decisions
Patients’ voice in access decisions
EUPATI
 
0201b rachford using qualitative and quantitative data how to structure you...
0201b rachford   using qualitative and quantitative data how to structure you...0201b rachford   using qualitative and quantitative data how to structure you...
0201b rachford using qualitative and quantitative data how to structure you...
Workgroup of European Cancer Patient Advocacy Networks
 
Drug development and treatment strategies may go hand in hand.
Drug development and treatment strategies may go hand in hand.Drug development and treatment strategies may go hand in hand.
Drug development and treatment strategies may go hand in hand.
EUPATI
 
Good practices in patient involvement in HTA
Good practices in patient involvement in HTAGood practices in patient involvement in HTA
Good practices in patient involvement in HTA
EUPATI
 
Patient involvement in clinical research and long term conditions -what can b...
Patient involvement in clinical research and long term conditions -what can b...Patient involvement in clinical research and long term conditions -what can b...
Patient involvement in clinical research and long term conditions -what can b...
Nowgen
 
Jornadas #PatientInHTA · Tamas Bereczky
Jornadas #PatientInHTA · Tamas BereczkyJornadas #PatientInHTA · Tamas Bereczky
Jornadas #PatientInHTA · Tamas Bereczky
Instituto Aragonés de Ciencias de la Salud - IACS
 
0307 Mary Wang - Biobanks and registries
0307 Mary Wang - Biobanks and registries0307 Mary Wang - Biobanks and registries
0307 Mary Wang - Biobanks and registries
Workgroup of European Cancer Patient Advocacy Networks
 
Don't just talk about patient centricity - put meaningful patient engagement ...
Don't just talk about patient centricity - put meaningful patient engagement ...Don't just talk about patient centricity - put meaningful patient engagement ...
Don't just talk about patient centricity - put meaningful patient engagement ...
jangeissler
 
0107 Jan Geissler - How drug development works and elements of trial protocols
0107 Jan Geissler - How drug development works and elements of trial protocols0107 Jan Geissler - How drug development works and elements of trial protocols
0107 Jan Geissler - How drug development works and elements of trial protocols
Workgroup of European Cancer Patient Advocacy Networks
 
Jornadas #PatientInHTA · Jesús González
Jornadas #PatientInHTA · Jesús GonzálezJornadas #PatientInHTA · Jesús González
Jornadas #PatientInHTA · Jesús González
Instituto Aragonés de Ciencias de la Salud - IACS
 
Patient engagement in clinical trials
Patient engagement in clinical trials Patient engagement in clinical trials
Patient engagement in clinical trials
Martin Kelly
 
Jornadas #PatientInHTA · François Houyez
Jornadas #PatientInHTA · François Houyez Jornadas #PatientInHTA · François Houyez
Jornadas #PatientInHTA · François Houyez
Instituto Aragonés de Ciencias de la Salud - IACS
 
Cadth 2015 e6 husereau rwe cadth
Cadth 2015 e6 husereau rwe cadthCadth 2015 e6 husereau rwe cadth
Cadth 2015 e6 husereau rwe cadth
CADTH Symposium
 
Jornadas #PatientInHTA ·Ruth Ubago
Jornadas #PatientInHTA ·Ruth UbagoJornadas #PatientInHTA ·Ruth Ubago
Jornadas #PatientInHTA ·Ruth Ubago
Instituto Aragonés de Ciencias de la Salud - IACS
 
Jornadas #PatientInHTA · Valentina Strammiello
Jornadas #PatientInHTA · Valentina StrammielloJornadas #PatientInHTA · Valentina Strammiello
Jornadas #PatientInHTA · Valentina Strammiello
Instituto Aragonés de Ciencias de la Salud - IACS
 
EUPATI guidances for interaction between Patient organisations and other stak...
EUPATI guidances for interaction between Patient organisations and other stak...EUPATI guidances for interaction between Patient organisations and other stak...
EUPATI guidances for interaction between Patient organisations and other stak...
EUPATI
 
Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...
Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...
Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...
EURORDIS - Rare Diseases Europe
 
0205 David Haerry - How and why does access to treatment and care differ
0205 David Haerry - How and why does access to treatment and care differ0205 David Haerry - How and why does access to treatment and care differ
0205 David Haerry - How and why does access to treatment and care differ
Workgroup of European Cancer Patient Advocacy Networks
 
Jornadas #PatientInHTA · Tammy Clifford
Jornadas #PatientInHTA · Tammy CliffordJornadas #PatientInHTA · Tammy Clifford
Jornadas #PatientInHTA · Tammy Clifford
Instituto Aragonés de Ciencias de la Salud - IACS
 
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...
Office of Health Economics
 

What's hot (20)

Patients’ voice in access decisions
Patients’ voice in access decisionsPatients’ voice in access decisions
Patients’ voice in access decisions
 
0201b rachford using qualitative and quantitative data how to structure you...
0201b rachford   using qualitative and quantitative data how to structure you...0201b rachford   using qualitative and quantitative data how to structure you...
0201b rachford using qualitative and quantitative data how to structure you...
 
Drug development and treatment strategies may go hand in hand.
Drug development and treatment strategies may go hand in hand.Drug development and treatment strategies may go hand in hand.
Drug development and treatment strategies may go hand in hand.
 
Good practices in patient involvement in HTA
Good practices in patient involvement in HTAGood practices in patient involvement in HTA
Good practices in patient involvement in HTA
 
Patient involvement in clinical research and long term conditions -what can b...
Patient involvement in clinical research and long term conditions -what can b...Patient involvement in clinical research and long term conditions -what can b...
Patient involvement in clinical research and long term conditions -what can b...
 
Jornadas #PatientInHTA · Tamas Bereczky
Jornadas #PatientInHTA · Tamas BereczkyJornadas #PatientInHTA · Tamas Bereczky
Jornadas #PatientInHTA · Tamas Bereczky
 
0307 Mary Wang - Biobanks and registries
0307 Mary Wang - Biobanks and registries0307 Mary Wang - Biobanks and registries
0307 Mary Wang - Biobanks and registries
 
Don't just talk about patient centricity - put meaningful patient engagement ...
Don't just talk about patient centricity - put meaningful patient engagement ...Don't just talk about patient centricity - put meaningful patient engagement ...
Don't just talk about patient centricity - put meaningful patient engagement ...
 
0107 Jan Geissler - How drug development works and elements of trial protocols
0107 Jan Geissler - How drug development works and elements of trial protocols0107 Jan Geissler - How drug development works and elements of trial protocols
0107 Jan Geissler - How drug development works and elements of trial protocols
 
Jornadas #PatientInHTA · Jesús González
Jornadas #PatientInHTA · Jesús GonzálezJornadas #PatientInHTA · Jesús González
Jornadas #PatientInHTA · Jesús González
 
Patient engagement in clinical trials
Patient engagement in clinical trials Patient engagement in clinical trials
Patient engagement in clinical trials
 
Jornadas #PatientInHTA · François Houyez
Jornadas #PatientInHTA · François Houyez Jornadas #PatientInHTA · François Houyez
Jornadas #PatientInHTA · François Houyez
 
Cadth 2015 e6 husereau rwe cadth
Cadth 2015 e6 husereau rwe cadthCadth 2015 e6 husereau rwe cadth
Cadth 2015 e6 husereau rwe cadth
 
Jornadas #PatientInHTA ·Ruth Ubago
Jornadas #PatientInHTA ·Ruth UbagoJornadas #PatientInHTA ·Ruth Ubago
Jornadas #PatientInHTA ·Ruth Ubago
 
Jornadas #PatientInHTA · Valentina Strammiello
Jornadas #PatientInHTA · Valentina StrammielloJornadas #PatientInHTA · Valentina Strammiello
Jornadas #PatientInHTA · Valentina Strammiello
 
EUPATI guidances for interaction between Patient organisations and other stak...
EUPATI guidances for interaction between Patient organisations and other stak...EUPATI guidances for interaction between Patient organisations and other stak...
EUPATI guidances for interaction between Patient organisations and other stak...
 
Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...
Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...
Workshop 6 - "Sharing expertise: transfer of experience from patient organiza...
 
0205 David Haerry - How and why does access to treatment and care differ
0205 David Haerry - How and why does access to treatment and care differ0205 David Haerry - How and why does access to treatment and care differ
0205 David Haerry - How and why does access to treatment and care differ
 
Jornadas #PatientInHTA · Tammy Clifford
Jornadas #PatientInHTA · Tammy CliffordJornadas #PatientInHTA · Tammy Clifford
Jornadas #PatientInHTA · Tammy Clifford
 
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...
How can HTA’s in Asia respond to Increased Clinical Uncertainty: the potentia...
 

Viewers also liked

Interview with: Carlos Gómez Plaza Director Tripartite Foundation for Trai...
Interview with:Carlos Gómez PlazaDirector Tripartite Foundation for Trai...Interview with:Carlos Gómez PlazaDirector Tripartite Foundation for Trai...
Interview with: Carlos Gómez Plaza Director Tripartite Foundation for Trai...
network_trainers
 
Circle of Protection Signatories
Circle of Protection SignatoriesCircle of Protection Signatories
Circle of Protection Signatories
Bread for the World
 
Teleportation of a Tripartite Entangled Coherent State
Teleportation of a Tripartite Entangled Coherent StateTeleportation of a Tripartite Entangled Coherent State
Teleportation of a Tripartite Entangled Coherent State
Vasudha Pande
 
Case Signatories ESPH
Case Signatories ESPHCase Signatories ESPH
Case Signatories ESPH
floresmichaeltangog
 
Freedomridersandsitins
FreedomridersandsitinsFreedomridersandsitins
Freedomridersandsitins
The Grange School & Sports College
 
ECOSOCSpratlyIslandsConflict
ECOSOCSpratlyIslandsConflictECOSOCSpratlyIslandsConflict
ECOSOCSpratlyIslandsConflict
Liaw Jia Xuan
 
Twitter for Coalitions
Twitter for CoalitionsTwitter for Coalitions
Twitter for Coalitions
LaDonna Coy
 
Church of england views on homosexuality
Church of england views on homosexualityChurch of england views on homosexuality
Church of england views on homosexuality
Academic Research Paper Writing Services
 
Case Signatories ESPH/BH
Case Signatories ESPH/BHCase Signatories ESPH/BH
Case Signatories ESPH/BH
floresmichaeltangog
 
Ethical Issues in the Tripartite Relationship
Ethical Issues in the Tripartite RelationshipEthical Issues in the Tripartite Relationship
Ethical Issues in the Tripartite Relationship
Brian Jones
 
Assessing the Capacity of Community Coalitions to Advocate for Change
Assessing the Capacity of Community Coalitions to Advocate for ChangeAssessing the Capacity of Community Coalitions to Advocate for Change
Assessing the Capacity of Community Coalitions to Advocate for Change
Innovation Network
 
Building resposible property portfolios: a review of current practices by u...
Building resposible property portfolios:   a review of current practices by u...Building resposible property portfolios:   a review of current practices by u...
Building resposible property portfolios: a review of current practices by u...
Dr Lendy Spires
 
February 22 in Cleveland, Ohio
February 22 in Cleveland, OhioFebruary 22 in Cleveland, Ohio
February 22 in Cleveland, Ohio
Laura McShane
 
Social Media 101 for Coalitions
Social Media 101 for CoalitionsSocial Media 101 for Coalitions
Social Media 101 for Coalitions
LaDonna Coy
 
Daniel Nepstad at "Taking stock of REDD+"
Daniel Nepstad  at "Taking stock of REDD+"Daniel Nepstad  at "Taking stock of REDD+"
Daniel Nepstad at "Taking stock of REDD+"
CIFOR-ICRAF
 
2.1 freedom riders writing assignment
2.1 freedom riders writing assignment2.1 freedom riders writing assignment
2.1 freedom riders writing assignment
bravogths
 

Viewers also liked (16)

Interview with: Carlos Gómez Plaza Director Tripartite Foundation for Trai...
Interview with:Carlos Gómez PlazaDirector Tripartite Foundation for Trai...Interview with:Carlos Gómez PlazaDirector Tripartite Foundation for Trai...
Interview with: Carlos Gómez Plaza Director Tripartite Foundation for Trai...
 
Circle of Protection Signatories
Circle of Protection SignatoriesCircle of Protection Signatories
Circle of Protection Signatories
 
Teleportation of a Tripartite Entangled Coherent State
Teleportation of a Tripartite Entangled Coherent StateTeleportation of a Tripartite Entangled Coherent State
Teleportation of a Tripartite Entangled Coherent State
 
Case Signatories ESPH
Case Signatories ESPHCase Signatories ESPH
Case Signatories ESPH
 
Freedomridersandsitins
FreedomridersandsitinsFreedomridersandsitins
Freedomridersandsitins
 
ECOSOCSpratlyIslandsConflict
ECOSOCSpratlyIslandsConflictECOSOCSpratlyIslandsConflict
ECOSOCSpratlyIslandsConflict
 
Twitter for Coalitions
Twitter for CoalitionsTwitter for Coalitions
Twitter for Coalitions
 
Church of england views on homosexuality
Church of england views on homosexualityChurch of england views on homosexuality
Church of england views on homosexuality
 
Case Signatories ESPH/BH
Case Signatories ESPH/BHCase Signatories ESPH/BH
Case Signatories ESPH/BH
 
Ethical Issues in the Tripartite Relationship
Ethical Issues in the Tripartite RelationshipEthical Issues in the Tripartite Relationship
Ethical Issues in the Tripartite Relationship
 
Assessing the Capacity of Community Coalitions to Advocate for Change
Assessing the Capacity of Community Coalitions to Advocate for ChangeAssessing the Capacity of Community Coalitions to Advocate for Change
Assessing the Capacity of Community Coalitions to Advocate for Change
 
Building resposible property portfolios: a review of current practices by u...
Building resposible property portfolios:   a review of current practices by u...Building resposible property portfolios:   a review of current practices by u...
Building resposible property portfolios: a review of current practices by u...
 
February 22 in Cleveland, Ohio
February 22 in Cleveland, OhioFebruary 22 in Cleveland, Ohio
February 22 in Cleveland, Ohio
 
Social Media 101 for Coalitions
Social Media 101 for CoalitionsSocial Media 101 for Coalitions
Social Media 101 for Coalitions
 
Daniel Nepstad at "Taking stock of REDD+"
Daniel Nepstad  at "Taking stock of REDD+"Daniel Nepstad  at "Taking stock of REDD+"
Daniel Nepstad at "Taking stock of REDD+"
 
2.1 freedom riders writing assignment
2.1 freedom riders writing assignment2.1 freedom riders writing assignment
2.1 freedom riders writing assignment
 

Similar to Tripartite dimension of interaction of patients, regulators and industry (Jan Geissler)

Changes in patient organisations - and how this changes the medical world
Changes in patient organisations - and how this changes the medical worldChanges in patient organisations - and how this changes the medical world
Changes in patient organisations - and how this changes the medical world
jangeissler
 
Alpha One Conference - IPPOSI
Alpha One Conference - IPPOSIAlpha One Conference - IPPOSI
Alpha One Conference - IPPOSI
ipposi
 
PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016
PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016
PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016
ipposi
 
EPIS meeting - Dr Derick Mitchell - October 2017
EPIS meeting - Dr Derick Mitchell - October 2017EPIS meeting - Dr Derick Mitchell - October 2017
EPIS meeting - Dr Derick Mitchell - October 2017
ipposi
 
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
EUPATI
 
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
EUPATI
 
1 engaging with ema methodology and support
1 engaging with ema methodology and support1 engaging with ema methodology and support
1 engaging with ema methodology and support
EURORDIS Rare Diseases Europe
 
Engaging with EMA methodology
Engaging with EMA methodology Engaging with EMA methodology
Engaging with EMA methodology
EURORDIS Rare Diseases Europe
 
EU Clinical Trials Regulation - IPPOSI perspective
EU Clinical Trials Regulation - IPPOSI perspectiveEU Clinical Trials Regulation - IPPOSI perspective
EU Clinical Trials Regulation - IPPOSI perspective
ipposi
 
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...
jangeissler
 
Patient-Centered Digital Health
Patient-Centered Digital HealthPatient-Centered Digital Health
Patient-Centered Digital Health
ipposi
 
Involvepresentation
InvolvepresentationInvolvepresentation
Involvepresentation
Nowgen
 
Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013
Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013
Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013
EUPATI
 
2023 ISPOR Patient Representatives Roundtable - Europe
2023 ISPOR Patient Representatives Roundtable - Europe2023 ISPOR Patient Representatives Roundtable - Europe
2023 ISPOR Patient Representatives Roundtable - Europe
ipposi
 
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
jangeissler
 
G2 report from breakout group 2
G2 report from breakout group 2G2 report from breakout group 2
G2 report from breakout group 2
EUPATI
 
EUPATI Launch Meeting - Jan Geissler
EUPATI Launch Meeting - Jan GeisslerEUPATI Launch Meeting - Jan Geissler
EUPATI Launch Meeting - Jan Geissler
jangeissler
 
F3 patient engagement-2015philadelphia
F3 patient engagement-2015philadelphiaF3 patient engagement-2015philadelphia
F3 patient engagement-2015philadelphia
Todd Berner MD
 
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the InternetJan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
patvocates
 
UCD PharmTox event on Clinical Trials
UCD PharmTox event on Clinical TrialsUCD PharmTox event on Clinical Trials
UCD PharmTox event on Clinical Trials
ipposi
 

Similar to Tripartite dimension of interaction of patients, regulators and industry (Jan Geissler) (20)

Changes in patient organisations - and how this changes the medical world
Changes in patient organisations - and how this changes the medical worldChanges in patient organisations - and how this changes the medical world
Changes in patient organisations - and how this changes the medical world
 
Alpha One Conference - IPPOSI
Alpha One Conference - IPPOSIAlpha One Conference - IPPOSI
Alpha One Conference - IPPOSI
 
PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016
PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016
PMI Masterclass - Derick Mitchell IPPOSI - October 19th 2016
 
EPIS meeting - Dr Derick Mitchell - October 2017
EPIS meeting - Dr Derick Mitchell - October 2017EPIS meeting - Dr Derick Mitchell - October 2017
EPIS meeting - Dr Derick Mitchell - October 2017
 
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
 
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
 
1 engaging with ema methodology and support
1 engaging with ema methodology and support1 engaging with ema methodology and support
1 engaging with ema methodology and support
 
Engaging with EMA methodology
Engaging with EMA methodology Engaging with EMA methodology
Engaging with EMA methodology
 
EU Clinical Trials Regulation - IPPOSI perspective
EU Clinical Trials Regulation - IPPOSI perspectiveEU Clinical Trials Regulation - IPPOSI perspective
EU Clinical Trials Regulation - IPPOSI perspective
 
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...
 
Patient-Centered Digital Health
Patient-Centered Digital HealthPatient-Centered Digital Health
Patient-Centered Digital Health
 
Involvepresentation
InvolvepresentationInvolvepresentation
Involvepresentation
 
Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013
Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013
Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013
 
2023 ISPOR Patient Representatives Roundtable - Europe
2023 ISPOR Patient Representatives Roundtable - Europe2023 ISPOR Patient Representatives Roundtable - Europe
2023 ISPOR Patient Representatives Roundtable - Europe
 
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
 
G2 report from breakout group 2
G2 report from breakout group 2G2 report from breakout group 2
G2 report from breakout group 2
 
EUPATI Launch Meeting - Jan Geissler
EUPATI Launch Meeting - Jan GeisslerEUPATI Launch Meeting - Jan Geissler
EUPATI Launch Meeting - Jan Geissler
 
F3 patient engagement-2015philadelphia
F3 patient engagement-2015philadelphiaF3 patient engagement-2015philadelphia
F3 patient engagement-2015philadelphia
 
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the InternetJan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
 
UCD PharmTox event on Clinical Trials
UCD PharmTox event on Clinical TrialsUCD PharmTox event on Clinical Trials
UCD PharmTox event on Clinical Trials
 

More from jangeissler

Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten
Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten
Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten
jangeissler
 
CML: A tiger in the cage? A (European) perspective on CML disease management
CML: A tiger in the cage? A (European) perspective on CML disease managementCML: A tiger in the cage? A (European) perspective on CML disease management
CML: A tiger in the cage? A (European) perspective on CML disease management
jangeissler
 
Sicht der Patienten auf Real World Data, Register und Versorgungsdaten
Sicht der Patienten auf Real World Data, Register und VersorgungsdatenSicht der Patienten auf Real World Data, Register und Versorgungsdaten
Sicht der Patienten auf Real World Data, Register und Versorgungsdaten
jangeissler
 
Überblick der Aktivitäten von Leukämie-Online und CML Advocates Network
Überblick der Aktivitäten von Leukämie-Online und CML Advocates NetworkÜberblick der Aktivitäten von Leukämie-Online und CML Advocates Network
Überblick der Aktivitäten von Leukämie-Online und CML Advocates Network
jangeissler
 
Andreas Willer - Rehabilitation für Patienten mit CML
Andreas Willer - Rehabilitation für Patienten mit CMLAndreas Willer - Rehabilitation für Patienten mit CML
Andreas Willer - Rehabilitation für Patienten mit CML
jangeissler
 
Umfrage zur Therapiefreien Remission (TFR) der CML-Patientengemeinschaft
Umfrage zur Therapiefreien Remission (TFR) der CML-PatientengemeinschaftUmfrage zur Therapiefreien Remission (TFR) der CML-Patientengemeinschaft
Umfrage zur Therapiefreien Remission (TFR) der CML-Patientengemeinschaft
jangeissler
 
Patientenperspektive im Studiendesign
Patientenperspektive im Studiendesign Patientenperspektive im Studiendesign
Patientenperspektive im Studiendesign
jangeissler
 
Reasonable Legal Agreements between Patient Advocates and Pharma Companies
Reasonable Legal Agreements between Patient Advocates and Pharma CompaniesReasonable Legal Agreements between Patient Advocates and Pharma Companies
Reasonable Legal Agreements between Patient Advocates and Pharma Companies
jangeissler
 
Bericht LeukaNET / leukaemie-online.de und CML Advocates Network
Bericht LeukaNET / leukaemie-online.de und CML Advocates NetworkBericht LeukaNET / leukaemie-online.de und CML Advocates Network
Bericht LeukaNET / leukaemie-online.de und CML Advocates Network
jangeissler
 
How to get the most of the EHA congress as a CML patient advocate
How to get the most of the EHA congress as a CML patient advocateHow to get the most of the EHA congress as a CML patient advocate
How to get the most of the EHA congress as a CML patient advocate
jangeissler
 
European Patient Perspective on Access and Innovation with Multiplex Genomic ...
European Patient Perspective on Access and Innovation with Multiplex Genomic ...European Patient Perspective on Access and Innovation with Multiplex Genomic ...
European Patient Perspective on Access and Innovation with Multiplex Genomic ...
jangeissler
 
European Cancer Patient Advocacy: Introduction to the community, key stakehol...
European Cancer Patient Advocacy: Introduction to the community, key stakehol...European Cancer Patient Advocacy: Introduction to the community, key stakehol...
European Cancer Patient Advocacy: Introduction to the community, key stakehol...
jangeissler
 
Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017
Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017
Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017
jangeissler
 
CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...
CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...
CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...
jangeissler
 
How to get the most of EHA as a patient advocate
How to get the most of EHA as a patient advocateHow to get the most of EHA as a patient advocate
How to get the most of EHA as a patient advocate
jangeissler
 
PCR-Info-Projekt (Cornelia Borowczak)
PCR-Info-Projekt (Cornelia Borowczak)PCR-Info-Projekt (Cornelia Borowczak)
PCR-Info-Projekt (Cornelia Borowczak)
jangeissler
 
CML-Studiendatenbank: Patienteninformationen für Studien
CML-Studiendatenbank: Patienteninformationen für StudienCML-Studiendatenbank: Patienteninformationen für Studien
CML-Studiendatenbank: Patienteninformationen für Studien
jangeissler
 
Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...
Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...
Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...
jangeissler
 
The benefits of patient involvement in research and development (RE:ACT Congr...
The benefits of patient involvement in research and development (RE:ACT Congr...The benefits of patient involvement in research and development (RE:ACT Congr...
The benefits of patient involvement in research and development (RE:ACT Congr...
jangeissler
 
Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...
Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...
Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...
jangeissler
 

More from jangeissler (20)

Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten
Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten
Relevanz von Laienzusammenfassungen von Studienergebnissen für Patienten
 
CML: A tiger in the cage? A (European) perspective on CML disease management
CML: A tiger in the cage? A (European) perspective on CML disease managementCML: A tiger in the cage? A (European) perspective on CML disease management
CML: A tiger in the cage? A (European) perspective on CML disease management
 
Sicht der Patienten auf Real World Data, Register und Versorgungsdaten
Sicht der Patienten auf Real World Data, Register und VersorgungsdatenSicht der Patienten auf Real World Data, Register und Versorgungsdaten
Sicht der Patienten auf Real World Data, Register und Versorgungsdaten
 
Überblick der Aktivitäten von Leukämie-Online und CML Advocates Network
Überblick der Aktivitäten von Leukämie-Online und CML Advocates NetworkÜberblick der Aktivitäten von Leukämie-Online und CML Advocates Network
Überblick der Aktivitäten von Leukämie-Online und CML Advocates Network
 
Andreas Willer - Rehabilitation für Patienten mit CML
Andreas Willer - Rehabilitation für Patienten mit CMLAndreas Willer - Rehabilitation für Patienten mit CML
Andreas Willer - Rehabilitation für Patienten mit CML
 
Umfrage zur Therapiefreien Remission (TFR) der CML-Patientengemeinschaft
Umfrage zur Therapiefreien Remission (TFR) der CML-PatientengemeinschaftUmfrage zur Therapiefreien Remission (TFR) der CML-Patientengemeinschaft
Umfrage zur Therapiefreien Remission (TFR) der CML-Patientengemeinschaft
 
Patientenperspektive im Studiendesign
Patientenperspektive im Studiendesign Patientenperspektive im Studiendesign
Patientenperspektive im Studiendesign
 
Reasonable Legal Agreements between Patient Advocates and Pharma Companies
Reasonable Legal Agreements between Patient Advocates and Pharma CompaniesReasonable Legal Agreements between Patient Advocates and Pharma Companies
Reasonable Legal Agreements between Patient Advocates and Pharma Companies
 
Bericht LeukaNET / leukaemie-online.de und CML Advocates Network
Bericht LeukaNET / leukaemie-online.de und CML Advocates NetworkBericht LeukaNET / leukaemie-online.de und CML Advocates Network
Bericht LeukaNET / leukaemie-online.de und CML Advocates Network
 
How to get the most of the EHA congress as a CML patient advocate
How to get the most of the EHA congress as a CML patient advocateHow to get the most of the EHA congress as a CML patient advocate
How to get the most of the EHA congress as a CML patient advocate
 
European Patient Perspective on Access and Innovation with Multiplex Genomic ...
European Patient Perspective on Access and Innovation with Multiplex Genomic ...European Patient Perspective on Access and Innovation with Multiplex Genomic ...
European Patient Perspective on Access and Innovation with Multiplex Genomic ...
 
European Cancer Patient Advocacy: Introduction to the community, key stakehol...
European Cancer Patient Advocacy: Introduction to the community, key stakehol...European Cancer Patient Advocacy: Introduction to the community, key stakehol...
European Cancer Patient Advocacy: Introduction to the community, key stakehol...
 
Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017
Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017
Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017
 
CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...
CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...
CML: What's New at EHA? Tim Brümmendorf, EHA Capacity Building Session, EHA c...
 
How to get the most of EHA as a patient advocate
How to get the most of EHA as a patient advocateHow to get the most of EHA as a patient advocate
How to get the most of EHA as a patient advocate
 
PCR-Info-Projekt (Cornelia Borowczak)
PCR-Info-Projekt (Cornelia Borowczak)PCR-Info-Projekt (Cornelia Borowczak)
PCR-Info-Projekt (Cornelia Borowczak)
 
CML-Studiendatenbank: Patienteninformationen für Studien
CML-Studiendatenbank: Patienteninformationen für StudienCML-Studiendatenbank: Patienteninformationen für Studien
CML-Studiendatenbank: Patienteninformationen für Studien
 
Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...
Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...
Schulung von Patientenvertreter ueber klinische Forschung. EUPATI und Arbeit ...
 
The benefits of patient involvement in research and development (RE:ACT Congr...
The benefits of patient involvement in research and development (RE:ACT Congr...The benefits of patient involvement in research and development (RE:ACT Congr...
The benefits of patient involvement in research and development (RE:ACT Congr...
 
Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...
Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...
Messen wir mit den gängigen QoL-Instrumenten noch das, was den Patienten bela...
 

Recently uploaded

Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024
Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024
Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024
Anindya Das Adhikary
 
THE MANAGEMENT OF PROSTATE CANCER . pptx
THE MANAGEMENT OF PROSTATE CANCER . pptxTHE MANAGEMENT OF PROSTATE CANCER . pptx
THE MANAGEMENT OF PROSTATE CANCER . pptx
Bright Chipili
 
General Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormonesGeneral Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormones
MedicoseAcademics
 
Text Book of Critical Care Nursing ICU NURSING
Text Book of Critical Care Nursing  ICU NURSINGText Book of Critical Care Nursing  ICU NURSING
Text Book of Critical Care Nursing ICU NURSING
BP KOIRALA INSTITUTE OF HELATH SCIENCS,, NEPAL
 
PICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptx
PICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptxPICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptx
PICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptx
Aloy Okechukwu Ugwu
 
SA Gastro Cure(pancreatic cancer treatment in india).pptx
SA Gastro Cure(pancreatic cancer treatment in india).pptxSA Gastro Cure(pancreatic cancer treatment in india).pptx
SA Gastro Cure(pancreatic cancer treatment in india).pptx
VinothKumar70905
 
STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...
STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...
STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...
Niranjan Chavan
 
Article - Design and evaluation of novel inhibitors for the treatment of clea...
Article - Design and evaluation of novel inhibitors for the treatment of clea...Article - Design and evaluation of novel inhibitors for the treatment of clea...
Article - Design and evaluation of novel inhibitors for the treatment of clea...
Trustlife
 
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptxProstatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
AmandaChou9
 
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
PVI, PeerView Institute for Medical Education
 
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
FFragrant
 
MEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate careMEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate care
Debre Berhan University
 
ONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. AmruthaONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. Amrutha
Amrutha Gudimetla
 
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
CarriePoppy
 
Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...
Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...
Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...
NephroTube - Dr.Gawad
 
Interpretation of ECG - Cardiac Arrhythmias
Interpretation of ECG - Cardiac ArrhythmiasInterpretation of ECG - Cardiac Arrhythmias
Interpretation of ECG - Cardiac Arrhythmias
MedicoseAcademics
 
How to Relieve Prostate Congestion- Here are some Effective Strategies.pptx
How to Relieve Prostate Congestion- Here are some Effective Strategies.pptxHow to Relieve Prostate Congestion- Here are some Effective Strategies.pptx
How to Relieve Prostate Congestion- Here are some Effective Strategies.pptx
AmandaChou9
 
Text Book of Nursing Concepts - Fundamental of Nursing
Text Book of Nursing Concepts - Fundamental of NursingText Book of Nursing Concepts - Fundamental of Nursing
Text Book of Nursing Concepts - Fundamental of Nursing
BP KOIRALA INSTITUTE OF HELATH SCIENCS,, NEPAL
 
PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...
PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...
PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...
Sarthi Life Sciences
 
Hand Book of Oncology Nursing - Cancer Nursing Book
Hand Book of Oncology Nursing - Cancer Nursing BookHand Book of Oncology Nursing - Cancer Nursing Book
Hand Book of Oncology Nursing - Cancer Nursing Book
BP KOIRALA INSTITUTE OF HELATH SCIENCS,, NEPAL
 

Recently uploaded (20)

Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024
Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024
Amygdala Medi-Trivia Quiz (Prelims) | FAQ 2024
 
THE MANAGEMENT OF PROSTATE CANCER . pptx
THE MANAGEMENT OF PROSTATE CANCER . pptxTHE MANAGEMENT OF PROSTATE CANCER . pptx
THE MANAGEMENT OF PROSTATE CANCER . pptx
 
General Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormonesGeneral Endocrinology and mechanism of action of hormones
General Endocrinology and mechanism of action of hormones
 
Text Book of Critical Care Nursing ICU NURSING
Text Book of Critical Care Nursing  ICU NURSINGText Book of Critical Care Nursing  ICU NURSING
Text Book of Critical Care Nursing ICU NURSING
 
PICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptx
PICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptxPICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptx
PICTURE TEST IN OBSTETRICS AND GYNAECOLOGY-Aloy Okechukwu Ugwu.pptx
 
SA Gastro Cure(pancreatic cancer treatment in india).pptx
SA Gastro Cure(pancreatic cancer treatment in india).pptxSA Gastro Cure(pancreatic cancer treatment in india).pptx
SA Gastro Cure(pancreatic cancer treatment in india).pptx
 
STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...
STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...
STRATEGIES FOR RATIONALISING/REDUCING CAESAREAN SECTION RATE BY USE OF "SION ...
 
Article - Design and evaluation of novel inhibitors for the treatment of clea...
Article - Design and evaluation of novel inhibitors for the treatment of clea...Article - Design and evaluation of novel inhibitors for the treatment of clea...
Article - Design and evaluation of novel inhibitors for the treatment of clea...
 
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptxProstatitis Severity- How to Determine if You Have Mild Symptoms.pptx
Prostatitis Severity- How to Determine if You Have Mild Symptoms.pptx
 
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
Stepping Forward to Transform MCL Management: Guidance on the Selection and U...
 
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
Safeguarding Reproductive Health- Preventing Fallopian Tube Blockage After a ...
 
MEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate careMEDICAL PROFESSIONALISM Class of compassionate care
MEDICAL PROFESSIONALISM Class of compassionate care
 
ONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. AmruthaONYDA XR clonidine liquid preparation by Dr. Amrutha
ONYDA XR clonidine liquid preparation by Dr. Amrutha
 
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
2024 07 12 Do you share my autistic traits_ - Google Sheets.pdf
 
Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...
Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...
Hemodialysis: Chapter 9, Arteriovenous Fistula and Graft: Basics, Creation, U...
 
Interpretation of ECG - Cardiac Arrhythmias
Interpretation of ECG - Cardiac ArrhythmiasInterpretation of ECG - Cardiac Arrhythmias
Interpretation of ECG - Cardiac Arrhythmias
 
How to Relieve Prostate Congestion- Here are some Effective Strategies.pptx
How to Relieve Prostate Congestion- Here are some Effective Strategies.pptxHow to Relieve Prostate Congestion- Here are some Effective Strategies.pptx
How to Relieve Prostate Congestion- Here are some Effective Strategies.pptx
 
Text Book of Nursing Concepts - Fundamental of Nursing
Text Book of Nursing Concepts - Fundamental of NursingText Book of Nursing Concepts - Fundamental of Nursing
Text Book of Nursing Concepts - Fundamental of Nursing
 
PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...
PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...
PCD Pharma Franchise For Gynae Products | Infertility Range - Sarthi Life Sci...
 
Hand Book of Oncology Nursing - Cancer Nursing Book
Hand Book of Oncology Nursing - Cancer Nursing BookHand Book of Oncology Nursing - Cancer Nursing Book
Hand Book of Oncology Nursing - Cancer Nursing Book
 

Tripartite dimension of interaction of patients, regulators and industry (Jan Geissler)

  • 1. The tripartite dimension of interaction of patients, regulators and industry Setting the scene and objectives for the day Jan Geissler & the EUPATI team The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
  • 2. Better medicines for patients: The tripartite interaction Patients Industry and Academia Regulators
  • 3. Patient involvement requires systematic interaction of all stakeholders  It is acknowledged* that patients’ contribution to the discovery, development and evaluation of medicines enriches • quality of research and development • quality of evidence and opinion • transparency, trust and mutual respect.  Close cooperation and partnership between the various stakeholders • pharmaceutical industry, • regulatory authorities and health technology assessment (HTA) bodies, • patients’ and consumers’ organisations, • healthcare professionals’ organisations, • academia, scientific and academic societies. Patients Industry and Academia Regulators * Adapted from EMA Framework
  • 4. Practical roadmap on Patient Involvement in Research and Development (R&D) Development design and Planning Design of Protocol Informed Consent Study reporting Post-study communication Patient Info Leaflet Trial steering committee Investigators Meeting Level of expertise in the disease area required: mediumhigh Data Monitoring CommitteePractical considerations Health Technology Assessment Protocol Synopsis Research priorities Setting research priorities: Information to Clinical Trial trial participants Development conduct and operations Regulatory affairs Dissemination, communication, post-approval Source: Geissler, Ryll, Leto, Uhlenhopp EPALCO/EUPATI (2015, unpublished) Fundraising for research Ethics Review
  • 5. EUPATI Fellows are increasingly engaging with industry, regulators and HTA Involvement of our EUPATI Fellows before and after the Patient Expert Training Course Role Before EUPATI After Member of patient organisation, not actively involved 20% 0% Active role in a patient organisation 60% 72% Leadership role in a patient organisation 52% 72% Employee of a patient organisation 20% 20% Volunteer role in a patient organisation 68% 84% Presenting at conferences, workshops etc. 44% 72% Advising a pharmaceutical company 8% 52% Advising a regulatory agency 12% 40% Advising a reimbursement agency 4% 8% Source: EUPATI Course 1 fellow survey, June 2016, N=25
  • 6. The interaction still has challenges  Cultivating our own garden, and lack of mutual learning (across/between industry, regulators, patient organisations)  Perceived or real legal barriers and conflict of interest  Silo-thinking and finger-pointing, leading to mushrooming of individual, non-consolidated processes, rules and codes  Lack of standardised metrics to measure benefits and impact  Lack of trust (amongst agencies, industry, patient organisations, politicians, lay audience, press), absorbing energy, time and motivation  Lack of capacity in patient organisations, lack of “universal patient experts in R&D”
  • 7. EUPATI has impact and has come with positive side effects, sustainability is key  5 years ago, EUPATI was formed to develop training material and run the Patient Expert Training Course  The “EUPATI boat” navigated safely through some stormy seas  EUPATI comes with positive side effects: • Many patients and their organisations have greatly improved on their collaboration with industry, or initiated interaction at levels not seen before • NCA & EMA initiated or increased new collaborations and improved existing ones. Trained patient experts knock at their doors & look for opportunities to provide input • HTA: Slow processes under national jurisdiction – some encouraging developments, and more patients trained on HTA methodologies than ever before • Ethics: Very disparate processes at national level, but increasing opportunities for patients. Increasing awareness of value of patient involvement in ethics committees  To date, rather little interest by public sponsors to support this movement, even though patients act in the interest of society!  EUPATI long-term sustainability is of major public health interest.
  • 8. EUPATI will continue!  EUPATI is the only dedicated training institution and trusted brand on patient involvement in medicines R&D.  EUPATI is hugely successful • ~100 EUPATI Fellows • >32.500 unique users of the Toolbox • >16 national EUPATI platforms  The current IMI1 funding will end in January 2017  EUPATI will continue as an EPF-led tripartite programme to harvest the fruits  During the “bridging phase”, EUPATI will focus on exploitation of Toolbox and will keep content up to date.
  • 9. Let’s go! Objectives for today  Share views, experience and learnings in pilot projects and evolution of processes of regulators, industry and patients, building on our 2014 workshop  Help ensure that the tripartite interaction is understood, respected and trusted by all stakeholders and the public at large.  Regulatory work stream: • Learn from pilot projects and regular/systematic involvement of patients both on EU and NCA level • Support interaction of regulators with patients  Industry work stream: • Discuss progress on evolution of industry processes to involve patients in all aspects of medicines R&D (e.g. clinical development plans, clinical trial design and conduct, compliance processes, patient information) • Encourage patient involvement earlier in a more meaningful, systematic manner
  • 10. Today’s agenda Setting the scene – patients, regulators and industry perspective Parallel work stream: INDUSTRY How industry processes and “actual implementation” has changed to involve patients in R&D: Cases and discussion Parallel work stream: REGULATORS Sharing how EMA and NCAs approach and/or implement patient involvement in regulatory authorities’ processes: Cases and discussion 10:00 11:30 14:30 Discussion How does that all fit together? Risks, independence, mishaps, educational needs, guidance documents 16:00 Report from the two work streams 15:00 (12:30 Lunch)
  • 11. How does this all fit together? Intended outcome when we part today.  Clear overview of regulators’, industry and patients’ respective viewpoints.  Shared experience and learnings of pilot projects and evolution of processes within regulatory and industry.  Discussed challenges and bottlenecks around potential conflicts of interest in collaboration within the ‘triangle’ of patient organisations, regulators and industry.  Developed collaborative solutions and safeguards to drive and nurture the collaboration.  Provided input into EUPATI guidance documents on interaction of patients/organisations with regulators, HTA, industry, ethics committees