Patients' involvement in ethics committees. A view from Austria.
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The document discusses patients' involvement in ethics committees in Austria. It describes the composition of ethics committees in Austria, which includes medical experts from different disciplines, a nursing staff member, pharmacist, person with ethical expertise, lawyer, statistician, patient advocacy organization representative, disability organization representative, and senior citizen representative. It then discusses the potential roles patients could play, including evaluating specific studies and assessing risk/burden, as well as providing a general patient perspective to strengthen the committee's position. Possible ways of collaboration are external review or participation in committee meetings either by a patient with the specific disease being studied or a "generic" patient representing overall patient views.
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Protection of subjects and informed consent - the clinical trials regulation ...
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Similar to Patients' involvement in ethics committees. A view from Austria.
Patients at the Centre of Patient Safety byEPF
This document summarizes a workshop on patient safety hosted by the European Patients' Forum (EPF). It defines key terms like patient safety, medical errors, and system failures. It outlines the EU legislative framework and opportunities for patient involvement. Survey results from EPF members showed low awareness of recommendations but a role for patient organizations in developing safety information. Members saw informing citizens, prioritizing safety, and involving patients and health professionals as important to better implement recommendations.
Patients at the Centre of Patient Safety by EPF
This document summarizes a workshop on patient safety held by the European Patients' Forum. It defines key terms like patient safety, medical errors, and the roles of patients and systems in ensuring safety. It outlines the EU legislative framework on safety and patients' rights. It also summarizes a survey of EPF members which found uneven implementation of recommendations on patient involvement across countries, but strong support for better informing and engaging patients and the public on safety issues.
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
Overview and Status Quo of the European Patients Academy (EUPATI) project, presented by EUPATI Director Jan Geissler at the EMA Patient and Consumer Working Party (PCWP) meeting in London on 26 Nov 2015
European Cancer Patients Achievements in cancer HTA Advocacy
The European Cancer Patient Coalition (ECPC) has advocated for harmonized health technology assessment (HTA) in the EU since 2014. Some of their milestones include publishing position papers, participating in EU consultations, and meeting with EU officials. HTA can promote innovation but differences between EU countries result in delays and inequities. Few HTA agencies involve patients systematically. The ECPC calls for mandatory uptake of joint clinical assessments and formal involvement of patient organizations at the EU and national levels. Patients are directly affected by HTA and their preferences on treatment are an important element.
Medical devices from patients' perspectives
The document discusses challenges around access to medical devices from patients' perspectives across Europe. It notes a lack of transparency in pricing and reimbursement processes and criteria for medical devices. In Hungary specifically, prior to 2010 the reimbursement system for medical devices was non-transparent without clear criteria or patient involvement. A new regulation in 2010 introduced a point-based system for reimbursement decisions, but there is still no experience with how well it will work.
An introduction to the EMA
The document discusses the role of patients, healthcare professionals, and academics in the European Medicines Agency's (EMA) process of approving medicines in the European Union. It describes how patients and patient organizations can provide input and expertise at various stages of the medicine development and review process. This includes involvement in scientific committees, evaluation of product information for patients, and review of safety communications. While patient participation has increased in recent years, challenges remain around representation, measuring impact, and ensuring comprehensive training. The EMA also facilitates collaboration with healthcare professionals and academics to enhance regulation and research.
Workshop 2 - "EURORDIS Policy recommendations based on EURORDIS Declaration, ...
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"EURORDIS Policy recommendations based on EURORDIS Declaration, Fact Sheets & Position Papers"
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This document discusses stakeholder engagement at the European Medicines Agency (EMA). It provides an overview of EMA's engagement with patients and consumers, healthcare professionals, and academia. EMA has engaged with these stakeholders since its creation in 1995, and has developed frameworks to facilitate interaction and collaboration. Key milestones in EMA's engagement include establishing working parties for patients and healthcare professionals, and creating a dedicated department for stakeholder relations. Challenges in stakeholder engagement include finding and training suitable experts, and measuring the impact of involvement. EMA addresses these through criteria for eligible organizations, support and training resources, and transparency around its engagement activities.
Engaging with EMA methodology
The document discusses the European Medicines Agency's (EMA) engagement with stakeholders such as patients, healthcare professionals, and academia. It outlines how EMA has built relationships with these groups since its creation in 1995, establishing frameworks and working groups to systematically involve them. It also describes challenges in stakeholder participation and how EMA addresses these, including providing support, training, and transparency around its processes. Overall, the document emphasizes how engagement with diverse perspectives has improved EMA's regulatory decisions.
How Effective is the Public in Influencing HTA Decisions?
Patients should be involved in HTA process to assure a robust process that embraces patients' needs, preferences, perspectives. ECPC-European Cancer Patient Coalition leverages on European Institutions for a solution to the timely authorization and reimbursement of innovative cancer medicines
Access to treatment, care and clinical trials by patients with rare cancers...
"Access to treatment, care and clinical trials by patients with rare cancers", presented by Jan Geissler (Twitter @jangeissler) at ESMO congress in Vienna, 30 Sept 2012
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
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Session 13 francesc_palau
This document discusses determinants and considerations for research on rare diseases from multiple perspectives. It notes both social and medical reasons for studying rare diseases, as they can provide insights into normal biological processes. An integrated and multidisciplinary approach is advocated, involving collaboration between basic and clinical researchers, as well as engagement with patient organizations, healthcare systems, and political actors to help foster research plans and infrastructure at both national and European levels.
European Patients' Rights Day 2015: PEDICINI (MEP)
This document summarizes a conference on chronic diseases and patients' rights in the framework of EU healthcare sustainability. It discusses how healthcare systems can remain active over time despite problems and crises by balancing solidarity and individualistic values with available resources and increasing costs. It also examines how increasing population age and disease prevalence are contributing to rising healthcare needs and costs. An alternative approach is proposed that bases healthcare financing on quality of care rather than amount of services provided. The document advocates for more objective and transparent criteria in healthcare systems that focus on health outcomes rather than diseases.
Obs presentation montevideo 2010 final 1
The document discusses the European Observatory on Health Systems and Policies, outlining its central principles, partnerships, governance, and core mission. The key points are:
1. The Observatory's central principles are to provide comparative analysis of health systems and policies, bridge the gap between evidence and policymaker needs, and develop practical policy options.
2. Partnerships with organizations like WHO and academic institutions are key to bridging this gap and ensuring research is relevant and accessible to policymakers.
3. Governance involves steering committees, independent academic directors, and a dedicated secretariat overseen by WHO.
4. The core mission is supporting evidence-based health policymaking through comprehensive analysis of European health systems,
Obs presentation montevideo 2010 final 1
The document discusses the European Observatory on Health Systems and Policies, outlining its central principles, partnerships, governance, and core mission. The key points are:
1. The Observatory's central principles are to provide comparative analysis of health systems and policies, bridge the gap between evidence and policymaker needs, and develop practical policy options.
2. Partnerships with organizations like WHO and academic institutions are key to bridging this gap and ensuring research is relevant and accessible to policymakers.
3. Governance involves steering committees, independent academic directors, and a dedicated secretariat to ensure credibility and quality.
4. The core mission is supporting evidence-based health policymaking through comprehensive analysis of European health systems
Patient empowerment at EU level - Katja Neubauer
Patient empowerment at EU level - Katja Neubauer, Deputy Head of Unit, Healthcare Systems Unit, DG Sanco for the 8th European Patients' Rights Day in Brussels, May 12th 2014
Jens Heisterberg - Patient involvement in drug development and licensing
Forskningsseminar hos KORA: "Hvordan involverer vi patienter i medicinsk forskning – og hvad betyder det for forskningen?" Den 02.03.2017
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
This document discusses increasing patient involvement in medical research and development. It notes that the medical landscape is transforming rapidly through innovations like personalized medicine and biomarkers. While this benefits patients, it also means smaller trial populations and a need for more post-marketing data. The document advocates for increasing patient involvement in areas like clinical trial design, setting research priorities, measuring quality of life, and pharmaceutical policy. It highlights the European Patients' Academy (EUPATI) project, which aims to empower patients through education on medical research and development processes in order to facilitate greater patient engagement.
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EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015
European Cancer Patients Achievements in cancer HTA Advocacy
European Cancer Patients Achievements in cancer HTA Advocacy
Workshop 2 - "EURORDIS Policy recommendations based on EURORDIS Declaration, ...
Workshop 2 - "EURORDIS Policy recommendations based on EURORDIS Declaration, ...
Thomas Sannié, Association francaise des hemophilies
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How Effective is the Public in Influencing HTA Decisions?
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Jan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
Jan Geissler - How Patient (Advocates) discuss Clinical Research on the Internet
European Patients' Rights Day 2015: PEDICINI (MEP)
European Patients' Rights Day 2015: PEDICINI (MEP)
Jens Heisterberg - Patient involvement in drug development and licensing
Jens Heisterberg - Patient involvement in drug development and licensing
EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...
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Mini-Course Starter Kits
EUPATI Webinar: Creating Trainings with the EUPATI Toolbox.
Time: 17:00 CET
Date: 20th of October from 17.00 to 18.30
Patient involvement prior to regulatory Scientific Advice
Stefan Herdinius
Increasing patient involvment
Patient involvement prior to regulatory Scientific Advice
EUPATI guidances for interaction between Patient organisations and other stak...
David Haerry
Increasing patient involvment
EUPATI guidances for interaction between Patient organisations and other stakeholders in medicines development
Introduction to the breakout sessions & case studies presentations
This document discusses Romania's progress toward establishing a national EUPATI platform. It notes that patients are currently represented in law debates regarding the health system and hospital ethics committees, but not in committees for the Romanian Drug Agency or health technology assessment meetings. It then outlines the initial steps taken to form a national EUPATI liaison team, including identifying trainees, academic representatives, media partners, and representatives from healthcare professional bodies. The document concludes by describing how EUPATI can benefit patients and advocates in Romania by increasing health literacy and facilitating greater participation in clinical trials and health policy decisions.
Introduction to the break out sessions & case studies presentations
The document summarizes the status of EUPATI in Spain. It outlines that a Spanish National Team was established in 2013 with various partners. Key accomplishments include launching the Spanish ENP, holding informational events, and establishing an Executive Board with representatives from patient organizations, academia, and pharmaceutical companies. Current activities involve spreading awareness and developing an action plan. Looking ahead, the Spanish team aims to have more participants in EUPATI training courses, utilize upcoming educational tools, and support new regulations enabling greater patient involvement in research and policy.
Introduction to the breakout sessions & case studies presentations
The document discusses the implementation of EUPATI in Italy. It notes that the project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, which is funded by the European Union's Seventh Framework Programme and EFPIA companies. It introduces representatives from the Italian National Leadership Team, including the NLT Chairman, patient organization representatives, an academia representative, and an industry representative. It discusses overcoming hurdles to implement the strategy in a combination of central and local strategies.
Introduction to the workshop and EUPATI update
The European Patients' Academy (EUPATI) project aims to educate patients and the public about medical research and development. It provides training to help patients become experts who can actively partner with researchers. The project is led by patients and involves various stakeholders. It has made progress in developing educational materials in multiple languages and establishing national networks. The first training course for patient experts recently began. EUPATI seeks to build understanding and empower patients to more actively engage in research.
G4 report from breakout group 4
The document summarizes discussions from a breakout group at the EUPATI 2015 Workshop regarding keeping EUPATI initiatives going over the long term and ensuring their success. Key points discussed include:
- Sharing best practices and experiences between national EUPATI initiatives to promote sustainability.
- Engaging local stakeholders through formal structures, promotional materials, transparency, and varied communication strategies.
- Positioning national initiatives as credible sources of information and links to European decision-making.
- Expanding collaboration between stakeholders and developing patient leadership over time.
G3 report from breakout group 3
This document summarizes a breakout group discussion from a EUPATI workshop on implementing the EUPATI project in countries where it is not already established. The group discussed how interested supporters in non-EUPATI countries could still work to establish EUPATI principles nationally by: looking for drivers and goals; requesting support materials from EUPATI; addressing potential hurdles; learning from other countries' experiences; and planning for sustainability without EUPATI funding. The breakout group represented 17 countries and identified steps individuals could take to advance patient involvement in medicines R&D where no formal EUPATI National Platform currently exists.
G2 report from breakout group 2
The document discusses setting up a National Learning Team (NLT) to establish a European Patients' Academy (ENP) in their country to implement the EUPATI program before the end of 2015. Key points discussed include finding champions in patient organizations, academia, and industry; creating effective partnerships between these stakeholders; developing strategic links and growing networks; and emphasizing the benefits EUPATI can provide like training opportunities and access to resources to promote patient public involvement.
G1 report from breakout group 1
This document summarizes the discussion from Break-Out Group 1 at the EUPATI 2015 Workshop regarding implementing EUPATI at the national level. Some key benefits of establishing a national EUPATI partner (ENP) include having a central point of contact for health policy questions, connecting diverse stakeholders, and facilitating multi-sectoral cooperation. National partners could include patient organizations, academics, regulatory authorities, healthcare professionals, and pharmaceutical companies. Strategic priorities for ENPs include disseminating EUPATI training and strengthening partnerships. Success would involve raising awareness, securing institutional support and sustainable funding, and becoming a go-to resource. ENPs should focus on building relationships, learning from more established programs, and leveraging partnerships
Communication & social media
This document provides guidance on using social media and communication tools effectively for patient organizations. It discusses how to create an online voice, examples from successful patient ambassadors, lessons from their experiences, and techniques for working smart with limited resources. Specific strategies and examples are provided for creating a meaningful brand difference, positioning an organization, running typical awareness and advocacy campaigns, and leveraging tools like social media, websites, videos, and crowdfunding campaigns.
Webinar: EUPATI Update to participants of the EUPATI Focus Groups - 4 Nov 2013
Webinar of the European Patients' Academy on Therapeutic Innovation (EUPATI) held on 4 Nov 2013 to update participants of its focus groups about project progress, results of the qualitative research, and how the recommendations translate into content production and dissemination activities of the project.
European Patients' Academy - Presentation at IMI Patient Focus Meeting on 12 ...
European Patients' Academy - Presentation at IMI Patient Focus Meeting on 12 June 2013, presented by Jan Geissler (@jangeissler), Director EUPATI (@EUPATIents) at the IMI's "Patient Focus" meeting, convening patient leaders from across Europe
EUPATI 2013 Conference: Welcome and Introduction
EUPATI 2013 Conference: Welcome and Introduction, by Anders Olauson, European Patients’ Forum (EPF), Sweden
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involvement in Medicines R&D, “Bring to life with EUPATI examples”, by Niels Westergaard, PhD, DSc Biopeople, University of Copenhagen, Denmark
EUPATI 2013 Conference: Patient involvement in medicines R&D: Bringing to li...
"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
Translating Patient Needs into Robust, Easily Accessible Quality Materials -...
This document discusses the development of educational materials for patients and the public about medicines research and development. It outlines the creation of an educational toolbox and internet library through a content development process involving editorial boards and subject matter experts. The materials will be freely available under a Creative Commons license.
Researching information needs and beliefs of patients, professionals and the ...
"Researching information needs and beliefs of patients, professionals and the public regarding medicines development", presentation held by Bella Starling on 6 March 2013 at DIA EuroMeeting
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Patient involvement prior to regulatory Scientific Advice
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EUPATI guidances for interaction between Patient organisations and other stak...
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Introduction to the breakout sessions & case studies presentations
Introduction to the breakout sessions & case studies presentations
Introduction to the break out sessions & case studies presentations
Introduction to the break out sessions & case studies presentations
Introduction to the breakout sessions & case studies presentations
Introduction to the breakout sessions & case studies presentations
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 2013
European Patients' Academy - Presentation at IMI Patient Focus Meeting on 12 ...
European Patients' Academy - Presentation at IMI Patient Focus Meeting on 12 ...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...
EUPATI 2013 Conference: Patient involvement in medicines R&D: Bringing to li...
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Translating Patient Needs into Robust, Easily Accessible Quality Materials -...
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Patients' involvement in ethics committees. A view from Austria.
- 1. A view from Austria Andrea Heckenberg Ethics Committee of Vienna Medical University Patients’ involvement in ethics committees
- 2. Composition of the EC in Austria Medical experts of all disciplines A member of the nursing staff A member of the pharmacy A member with ethical expertise A lawyer A statistician A member of an organisation representing patients (patient advocacy) A representative of an organisation of people with disabilities A senior citizen representative Regulated in the Hospital Act, the Medicines Act, the Medical Devices Act and the University Act
- 3. Potential role of the patient in the EC study specific • evaluation of the ICF • assessment of risk and burden general • giving additional impact to the opinion of the EC, thereby strengthening its position, in addressing recurring issues, e.g. – poor quality of ICFs – legal restrictions that „over-protect“ participants and prevent valuable research
- 4. Possible ways of collaboration External review Participation in EC meeting – Patient with the specific disease • for each study the presence of a different patient is required – „Generic“ patient • a person representing „the patient‘s view“ is present throughout the meeting For choosing appropriate patient participants the EC will have to be able to rely on a well organised patient organisation network