Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Is there patient involvement in HTA? Can patients influence HTA decision making?Kathi Apostolidis
Is HTA purely technical?
drivers for patient involvement in HTA
patient participation or tokenism
medicines do not reach patients due to delays in HTA evaluation
need for harmonized HTA
Drug development and treatment strategies may go hand in hand.EUPATI
How early in the development of a new medicine should the discussion between researchers and patients occur? Can such early strategic interaction really maximize the value of the outcome? In this EUPATI webinar, a pharmaceutical industry researcher and a patient expert will present two cases describing the research questions, their interaction and the outcome of this early collaboration. Join us in listening and discussing two very interesting experiences of successful patient involvement in the development of new medicines.
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led medicines R&D, regulatory authorities, ethics committees and HTA agencies. This webinar focuses on the Patient Involvement in Industry-led R&D guidance document
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...jangeissler
"Education of patients (advocates) on R&D: European Patients’ Academy EUPATI", presented by Jan Geissler at the Careum Congress on 18 March 2014 in Basel
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
The Observatory of Innovation in Healthcare Management in Catalonia is the instrument used by the Catalan health system to catalogue the efforts made by organisations in innovating in several spheres of management. See more information at http://oigs.gencat.cat
Patient involvement in clinical research and long term conditions -what can b...Nowgen
"Patient involvement in clinical research and long term conditions -what can be achieved by working in partnership", presented by Dr. J. Paul Schofield, ABPI, at EUPATI-UK Network Conference on 6 March 2014 in Leeds, UK
Patients at the Centre for Health Research – Patient, Carer and Public Invol...Nowgen
"Patients at the Centre for Health Research –
Patient, Carer and Public Involvement in NICE Decision-Making", presented by Victoria Thomas, NICE, at the EUPATI-UK Network Conference on 6 March 2014 in Leeds, UK
Tripartite dimension of interaction of patients, regulators and industry (Jan...jangeissler
Tripartite dimension of interaction of patients, regulators and industry, presented by Jan Geissler as a scene-setting presentation at the EUPATI Workshop on the interaction of patients, regulators and industry on 20 July 2016 in Berlin
EUPATI 2013 Conference: Patient involvement in medicines R&D: Bringing to li...EUPATI
"Patient involvement in medicines R&D: Bringing to life with EUPATI", presented by Jan Geissler, EUPATI Director, at the EUPATI 2013 Conference on 19 April 2013
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
Is there patient involvement in HTA? Can patients influence HTA decision making?Kathi Apostolidis
Is HTA purely technical?
drivers for patient involvement in HTA
patient participation or tokenism
medicines do not reach patients due to delays in HTA evaluation
need for harmonized HTA
Drug development and treatment strategies may go hand in hand.EUPATI
How early in the development of a new medicine should the discussion between researchers and patients occur? Can such early strategic interaction really maximize the value of the outcome? In this EUPATI webinar, a pharmaceutical industry researcher and a patient expert will present two cases describing the research questions, their interaction and the outcome of this early collaboration. Join us in listening and discussing two very interesting experiences of successful patient involvement in the development of new medicines.
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led medicines R&D, regulatory authorities, ethics committees and HTA agencies. This webinar focuses on the Patient Involvement in Industry-led R&D guidance document
Education of patients (advocates) on R&D: European Patients’ Academy EUPATI...jangeissler
"Education of patients (advocates) on R&D: European Patients’ Academy EUPATI", presented by Jan Geissler at the Careum Congress on 18 March 2014 in Basel
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
The Observatory of Innovation in Healthcare Management in Catalonia is the instrument used by the Catalan health system to catalogue the efforts made by organisations in innovating in several spheres of management. See more information at http://oigs.gencat.cat
Patient involvement in clinical research and long term conditions -what can b...Nowgen
"Patient involvement in clinical research and long term conditions -what can be achieved by working in partnership", presented by Dr. J. Paul Schofield, ABPI, at EUPATI-UK Network Conference on 6 March 2014 in Leeds, UK
Patients at the Centre for Health Research – Patient, Carer and Public Invol...Nowgen
"Patients at the Centre for Health Research –
Patient, Carer and Public Involvement in NICE Decision-Making", presented by Victoria Thomas, NICE, at the EUPATI-UK Network Conference on 6 March 2014 in Leeds, UK
Tripartite dimension of interaction of patients, regulators and industry (Jan...jangeissler
Tripartite dimension of interaction of patients, regulators and industry, presented by Jan Geissler as a scene-setting presentation at the EUPATI Workshop on the interaction of patients, regulators and industry on 20 July 2016 in Berlin
EUPATI 2013 Conference: Patient involvement in medicines R&D: Bringing to li...EUPATI
"Patient involvement in medicines R&D: Bringing to life with EUPATI", presented by Jan Geissler, EUPATI Director, at the EUPATI 2013 Conference on 19 April 2013
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015jangeissler
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EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...EUPATI
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EUPATI’s framework on Informing the “health-interested” public about medicine...Nowgen
"EUPATI's framework on Informing the “health-interested” public objectively and comprehensively about medicines R&D", presented by Jan Geissler at the EUPATI 2014 Workshop in Warsaw
European Patients’ Academy on Therapeutic Innovation:Shifting paradigms in ...patvocates
"European Patients’ Academy on Therapeutic Innovation: Shifting paradigms in empowering patients on medical R&D": Presentation by Jan Geissler (Twitter @jangeissler) at the Belgian Association of Clinical Research Professionals (ACRP.be) meeting on 25 Oct 2012
EU Clinical Trials Regulation - IPPOSI perspectiveipposi
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EUPATI guidances for interaction between Patient organisations and other stak...EUPATI
David Haerry
Increasing patient involvment
EUPATI guidances for interaction between Patient organisations and other stakeholders in medicines development
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1. 28 April 2017
The European Patients’ Academy
(EUPATI)
HTA involvement
2. What this presentation covers:
Why EUPATI?
What is EUPATI?
What has EUPATI delivered?
EUPATI and HTA guidance
3. Health research & policy is changing
at a fast pace
Innovation transforms the lives of
patients with serious, lifelong conditions:
Molecular targets/pathways
Genome sequencing,
Translational research
Personalized medicine
• Small trial populations
• Biomarkers, companion diagnostics
Need for post-marketing data
Health Technology Assessment,
QoL, endpoints, comparators
BUT long term pressure on health budgets
– here to stay
Window of
opportunity
trial design
relationship
between
researchers,
regulators,
industry,
patients
3
4. Public
Research Ethics
Committees
Competent
authorities
Policy makers
/Research Policy
HTA agencies
& committees
Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
Clinical
Research
Patients have a key role in all aspects of
health-related research
Trial protocol design,
informed consent, ethical
review, marketing
authorization, value
assessment, health policy
5. Patient involvement in practice
within the R&D life cycle
Source: Geissler, Ryll, Leto, Uhlenhopp – www.eupati.eu
Source: Geissler, Ryll, Uhlenhopp, Leto (2016): www.eupati.eu
6. Public
Research Ethics
Committees
Competent
authorities
Policy makers
/Research Policy
HTA agencies
& committees
Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
Clinical
Research
Patients have a key role in all aspects of
health-related research
Trial protocol design,
informed consent, ethical
review, marketing
authorization, value
assessment, health policy
7. EUPATI: Paradigm shift in empowering
patients on medicines R&D
Launched Feb 2012 as a public private
partnership, 33 consortium members,
Funded by Innovative Medicines Initiative
has developed and disseminate
objective, credible, correct and up-to-date
public knowledge about medicines R&D
is building competencies & expert capacity
among patients and the public,
has been a game changer and driver of patient engagement in R&D
Continues as a permanent educational programme
8. EUPATI Patient Experts
Training Course
-- for expert patients
EUPATI is developing education targeted
at different levels
EUPATI Educational
Toolbox
-- for patient advocates
EUPATI
Internet Library
-- for the health-interested public
English
French
German
Spanish
Polish
Italian
Russian
(Rumanian)
(Portuguese)
English
1.Discovery of
Medicines
2.Pre-clinical
Development
3.Clinical
Development
4.Clinical Trials
5.Regulatory
Affairs, Drug
Safety,
Pharmaco-
vigilance
6.Health
Technology
Assessment
11. 18+ EUPATI National Platforms
EUPATI National Platforms...
bring all stakeholders together in countries
address educational needs in R&D
disseminate EUPATI’s training material to patient
organisations
National platforms set up in AT, FR, DE, IE, IT, LU, MT,
PL, ES, CH, UK, DK, SK, PT
Additional platform initiatives ongoing NO, GR, RO, SRB, SE
12. What are ENPs doing?
ENP social media
campaigns
ENP learning
webinars
ENP workshops &
conferences
ENP MoUs with
partners
ENPs on the TV
ENPs in the
papers
13. The EUPATI Guidances
on the interaction of patients
with regulators, HTA bodies,
industry and ethics committees
14. EUPATI Guidances for patient
involvement and interaction – Why?
Patients & patient organisations to be involved more widely
• include early & post-approval stages,
not confined to clinical development
Overarching guidance on meaningful and ethical interaction
is missing in many areas, especially in R&D, causing insecurity
• Existing codes/regulations hold mostly legal & ethical content,
i.e. collaboration, communication, funding
-- do not cover patient involvement in R&D
• e.g. EFPIA, EATG code, PCWP framework, ECAB,
EMA framework, HTAi
Language needs to be more directive towards patient involvement
• Clear default statement that collaboration is allowed unless
expressly forbidden
15. EUPATI Guidances to support the interaction
with patient organisations in R&D
EUPATI has developed guidances for the interaction of
patient organisations with stakeholders
in industry-led R&D
in HTA bodies
in regulatory processes
in ethics committees
Available for download at
EUPATI.eu > Resources > Guidances
16. Guidance on interaction between patients
and HTA bodies
Definition of terms
Definition of rationale
Reference to frames and examples used
Basic tenets:
• Relevance
• Fairness
• Equity
• Legitimacy
• Capacity building
Practical guidance for HTA bodies on what to do and how
Practical guidance for POs on what to do and how