Presentation - New Business Models for Antibiotics: Where Are We Now? 16 Marc...Office of Health Economics
Speaking at the Superbugs & Superdrugs conference in London on 16 March 2016, OHE’s Jorge Mestre-Ferrandiz delivered a presentation on financial and collaborative incentives to accelerate clinical success for antibiotics.
Jorge discussed the economic challenges around antibiotics, and whether there is a need for a new business model. He reviewed of the impact of previous incentives, explaining what has worked in the past, and discussed possible new business models.
The IMI EHDEN project: large-scale analysis of observation data in Europe - C...Maxim Moinat
This document summarizes presentations from the CDISC 2020 Europe Interchange conference on April 1-2, 2020. It introduces Maxim Moinat who works on converting healthcare data to the OMOP Common Data Model. It also introduces Nigel Hughes who is the project lead for the IMI2 European Health Data & Evidence Network (EHDEN) and was previously involved in other real-world data projects. The document provides an agenda for the conference sessions which will discuss EHDEN, OHDSI, a EHDEN study-a-thon, using real-world data in clinical trials and for regulatory purposes.
This document provides an overview of MoCA (Mechanism of Coordinated Access to Orphan Medicinal Products). It discusses how MoCA aims to establish early dialogue between patients, payers, and companies to anticipate and address access issues for orphan medicines in Europe. The document outlines MoCA's history, goals, process, benefits, and examples of pilots. It emphasizes the importance of MoCA in helping ensure patients have access to important new therapies for rare diseases.
Evaluating Health Technology Assessment Reports and New Assessment Techniques...bpstat
2nd Annual Health Outcomes and Pharmacoeconomics Research Conference
• Setting up internal processes to ensure proper Health
Technology Assessment (HTA)
• Exploring initiatives to translate reported outcomes to
ensure proper understanding of data
• Assessing the key HTA entities in the U.S. and establishing
assessment protocol
• Differentiating HTA strategies with new technology
assessment strategies to improve assessment processes
Health technology assessment (HTA) is familiar as technique for gauging the value of specific medical technologies or approaches to care. As Adrian Towse points out, however, HTA has a much broader, ‘macro’ role in contributing to the efficiency of health care systems and supporting universal health coverage. This is particularly crucial in the face of increasing demands and limited budgets.
Presentation - New Business Models for Antibiotics: Where Are We Now? 16 Marc...Office of Health Economics
Speaking at the Superbugs & Superdrugs conference in London on 16 March 2016, OHE’s Jorge Mestre-Ferrandiz delivered a presentation on financial and collaborative incentives to accelerate clinical success for antibiotics.
Jorge discussed the economic challenges around antibiotics, and whether there is a need for a new business model. He reviewed of the impact of previous incentives, explaining what has worked in the past, and discussed possible new business models.
The IMI EHDEN project: large-scale analysis of observation data in Europe - C...Maxim Moinat
This document summarizes presentations from the CDISC 2020 Europe Interchange conference on April 1-2, 2020. It introduces Maxim Moinat who works on converting healthcare data to the OMOP Common Data Model. It also introduces Nigel Hughes who is the project lead for the IMI2 European Health Data & Evidence Network (EHDEN) and was previously involved in other real-world data projects. The document provides an agenda for the conference sessions which will discuss EHDEN, OHDSI, a EHDEN study-a-thon, using real-world data in clinical trials and for regulatory purposes.
This document provides an overview of MoCA (Mechanism of Coordinated Access to Orphan Medicinal Products). It discusses how MoCA aims to establish early dialogue between patients, payers, and companies to anticipate and address access issues for orphan medicines in Europe. The document outlines MoCA's history, goals, process, benefits, and examples of pilots. It emphasizes the importance of MoCA in helping ensure patients have access to important new therapies for rare diseases.
Evaluating Health Technology Assessment Reports and New Assessment Techniques...bpstat
2nd Annual Health Outcomes and Pharmacoeconomics Research Conference
• Setting up internal processes to ensure proper Health
Technology Assessment (HTA)
• Exploring initiatives to translate reported outcomes to
ensure proper understanding of data
• Assessing the key HTA entities in the U.S. and establishing
assessment protocol
• Differentiating HTA strategies with new technology
assessment strategies to improve assessment processes
Health technology assessment (HTA) is familiar as technique for gauging the value of specific medical technologies or approaches to care. As Adrian Towse points out, however, HTA has a much broader, ‘macro’ role in contributing to the efficiency of health care systems and supporting universal health coverage. This is particularly crucial in the face of increasing demands and limited budgets.
This document advertises and provides an agenda for the "Data Quality & Technology in Clinical Trials 2016" conference to be held in Philadelphia on April 18-19, 2016. The conference will focus on how pharmaceutical companies can maximize data quality, become data-driven organizations, and harness analytics to improve clinical trial design, monitoring, and outcomes. Speakers will include executives from major pharmaceutical companies as well as regulators and discuss topics like unlocking value from clinical trial data, using patient-generated data, and harnessing new technologies in clinical trials. The goal is to help pharmaceutical companies transition to being data-driven organizations and improve clinical development timelines and success rates through better data practices and technologies.
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
This document summarizes a kick-off meeting for the SAFTINet project. The meeting welcomed collaborators and outlined goals of establishing a distributed research network to conduct comparative effectiveness research using electronic health data from multiple healthcare organizations. The agenda included introductions of participating organizations, presentations on comparative effectiveness research and the technical capabilities needed, and discussions around engaging partners and getting started with the work.
EPIS meeting - Dr Derick Mitchell - October 2017ipposi
Derick Mitchell gave a talk on sustaining patient engagement resources through public-private platforms. Some key points:
1. He discussed IPPOSI, a patient-led organization that advocates for patient involvement in health innovation and research.
2. Patient organizations and industry can interact by moving past compliance and instead measuring the value of their interactions through trust and transparency.
3. Generating patient-based evidence through patient registries, mobile apps, and other tools can provide cost-effective, patient-relevant data to inform decision making.
The document summarizes a presentation on managed entry agreements for high-cost innovative pharmaceuticals. It discusses the issues of assessing value for money given uncertainty around health effects and budget impact. It defines managed entry agreements and performance-based risk-sharing agreements as formal arrangements to address these issues. While these schemes aim to improve access to innovative treatments, the evidence on their effectiveness is limited and implementation has proven difficult, particularly for outcomes-based arrangements. Overall, more structured evaluation is still needed but these schemes may help address challenges posed by high-priced drugs when traditional reimbursement is not suitable.
Improving the development of diagnostics testsMarilia Costa
1) Rapid diagnostic tests have great potential to improve healthcare in low- and middle-income countries by enabling accurate and timely treatment, but many barriers currently limit their development and deployment.
2) Key barriers include insufficient prioritization of diagnostics, financial challenges, demanding technical requirements, shortcomings in evaluation methods, complex regulatory systems, lack of quality assurance, and inadequate involvement of private healthcare providers.
3) Potential solutions involve prioritizing diagnostics development globally and nationally, using economic incentives, promoting locally-driven design, strengthening regulatory frameworks and quality assurance, engaging private providers, and developing flexible tools to support surveillance and differential diagnosis.
The document provides an overview of innovation and intellectual property (IP) processes at Alberta Health Services (AHS). It discusses definitions of innovation in healthcare and the importance of innovation and IP for health systems. It outlines AHS' IP policy and the processes for evaluating, managing, and commercializing innovations and IP from conception through stages of development. This includes establishing an Innovation Portal for identifying and advancing innovations, and conducting health technology assessments. A case study on a LINAC-MR radiation therapy project demonstrates applying these processes and developing a commercialization plan for an AHS-owned innovation. The document aims to provide guidance to innovators on partnering with AHS to advance healthcare innovations.
This document introduces the team and project for Media4Patient. The project aims to improve clinical trial enrollment through a new digital platform using social media and mobile technologies. It outlines challenges with patient recruitment such as many trials not reaching full enrollment and patients being unaware of clinical trial options. It then discusses stakeholders in clinical trials and viewpoints from different groups. Finally, it performs a PESTEL analysis to examine political, economic, technological, legal, environmental and socio-cultural factors affecting the project.
Why RWE Matters to Payers: Incorporating RWE in Health Economic Analysis to M...Office of Health Economics
1. Real world data (RWD) collected outside clinical trials reflects outcomes in the real world. Real world evidence (RWE) generated from RWD can help understand effectiveness, maximize value for payers, and manage uncertainty given evolving research and development.
2. Managed entry agreements (MEAs) are used to formally incorporate RWD to manage product entry addressing uncertainty while maximizing payer value through performance-linked reimbursement or coverage with evidence development.
3. Challenges to the use of RWE include implementation burdens, governance of data collection and analysis, and methodological issues in dealing with less controlled real world data.
Clinical Trial Data Transparency: Explaining Governance for Public Data SharingHealth Data Consortium
Watch the webinar here: http://www.screencast.com/t/0lATKYlJ8
Dr. Chris Boone, then-VP in Avalere’s Evidence Translation and Implementation Practice, discussed clinical trial data transparency and considerations for governance and open data sharing. Clinical trials are extremely valuable as the primary data source for seeking regulatory approval of products. Historically, regulatory agencie have been the sole recipients of clinical trial data, butthere has been a recent push from various stakeholder groups to open access to clinical trial data to non-regulatory researchers as an act of ethical responsibility to patients, a contribution to public health, and a demonstrated commitment to advancing the science. Some of the barriers include developing a sound approach for de-identifying patient data, adopting universal clinical trial data format, and managing the proactive and non-selective access and security of clinical data once collected. Dr. Boone discusses rationales and benefits/risks of clinical trial transparency, responsible use of publicly sharing this data, barriers and legal implications, and reasonable data sharing models.
Discover more health data resources on our website at http://www.healthdataconsortium.org/
MCDA can help address some challenges in health technology assessment by systematically considering multiple criteria, such as health impacts, costs, equity and other value dimensions. Some countries have piloted the use of MCDA in HTA processes, but there are still open questions around which criteria and weights to use, how to incorporate opportunity costs and deal with uncertainty. While MCDA shows promise for improving transparency and decision-making in HTA, further work is needed to balance its benefits and costs for different healthcare systems.
All patients are different, and data collected during product development or Randomised Clinical Trials (RCT) does not always paint the full picture of everyday patients. RWE insights complement the manufacturing process and RCT findings, adding more value and providing real-world impact. While together data from the manufacturing process and RWD paint a fuller picture.
Due to the limitations of the study design, data from the manufacturing process and RCTs are inadequate for demonstrating an intervention’s long-term safety and effectiveness. Moreover, it is possible to compare multiple product or interventions in RWE.
SMi Group's Adaptive Designs in Clinical Trials conferenceDale Butler
This document summarizes an upcoming conference on adaptive designs in clinical trials taking place from April 20-21, 2015 in London. The conference will focus on topics such as Bayesian adaptive designs, subgroup selection in clinical trials, integrating real-world patient data into adaptive trials, and designing biomarker-driven multi-arm multi-stage cancer trials. Speakers will discuss challenges with adaptive designs and their use in different therapeutic areas like neurodegenerative diseases. Participants can also register for optional half-day workshops on April 22nd focusing on Bayesian clinical trial designs and navigating international regulatory landscapes for adaptive trials.
The PRIME scheme aims to foster the development of medicines that address major unmet medical needs. It provides early and enhanced regulatory support through scientific advice and accelerated assessment. Since launching in 2016, over 50% of requests have come from small-to-medium enterprises. Of the 177 requests received, 36 products have been granted eligibility, covering a wide range of therapeutic areas. Key benefits for eligible products include early regulatory advice, a dedicated contact point, and potential for accelerated review. After two years, PRIME continues to successfully promote the development of promising medicines focused on unmet needs.
OHE Lunchtime Seminar with Associate Professor Paula Lorgelly, Deputy Director, Office of Health Economics
From the Antipodes to the Motherland: reflections on HTA decision makers as budget takers and budget makers
EuroBioForum 2013 - Day 2 | Mark PoznanskyEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# REGIONAL PERSPECTIVES #
Ontario Genomics Institute, Canada:
Innovative Research, Innovative Translation
Dr Mark Poznansky
President and CEO Ontario Genomics Institute
=======================================
http://www.eurobioforum.eu
This document discusses a new drug development paradigm (NDDP) that aims to improve the efficiency and effectiveness of clinical drug development. It outlines several proposals that call for reforming the current drug development model, including using more modeling, adaptive trial designs, and integrating clinical trials into healthcare delivery systems. The NDDP proposes a more flexible framework with early patient/payer engagement, exploratory and confirmatory research phases using modern trial designs, and post-approval studies to establish relative value. Challenges for industry include conducting large simple trials, partnering to support more efficient trials, and having a clear evidentiary strategy tailored to different drug archetypes.
Real world evidence pharmaceutical industry-plPeter Le
This document discusses the challenges and opportunities of real-world evidence (RWE) in the pharmaceutical industry. It notes that while RWE from real-world data can help improve drug development, operations, and decision-making, there are also challenges to overcome. These include issues with data accessibility, analysis capacity, and balancing limited resources. However, RWE also presents opportunities to increase value, understand effectiveness beyond clinical trials, and gain business insights. Overall, RWE brings significant opportunities if pharmaceutical companies can address solvable challenges through leadership, governance, and transformation.
This document is a final project essay about language learning methods. It discusses how traditional behavioral learning approaches that focus on repetition and stimulus-response can be boring and demotivating for students. However, more constructivist approaches that engage students and allow them to construct their own understanding may lead to more meaningful learning. The essay also analyzes a play about a student experiencing bullying at school and lack of motivation due to his teacher-centered classroom, showing how alternative approaches could help. It concludes that teachers need new, student-centered methods and a supportive environment to improve learning outcomes and prevent issues like bullying.
This document advertises and provides an agenda for the "Data Quality & Technology in Clinical Trials 2016" conference to be held in Philadelphia on April 18-19, 2016. The conference will focus on how pharmaceutical companies can maximize data quality, become data-driven organizations, and harness analytics to improve clinical trial design, monitoring, and outcomes. Speakers will include executives from major pharmaceutical companies as well as regulators and discuss topics like unlocking value from clinical trial data, using patient-generated data, and harnessing new technologies in clinical trials. The goal is to help pharmaceutical companies transition to being data-driven organizations and improve clinical development timelines and success rates through better data practices and technologies.
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
This document summarizes a kick-off meeting for the SAFTINet project. The meeting welcomed collaborators and outlined goals of establishing a distributed research network to conduct comparative effectiveness research using electronic health data from multiple healthcare organizations. The agenda included introductions of participating organizations, presentations on comparative effectiveness research and the technical capabilities needed, and discussions around engaging partners and getting started with the work.
EPIS meeting - Dr Derick Mitchell - October 2017ipposi
Derick Mitchell gave a talk on sustaining patient engagement resources through public-private platforms. Some key points:
1. He discussed IPPOSI, a patient-led organization that advocates for patient involvement in health innovation and research.
2. Patient organizations and industry can interact by moving past compliance and instead measuring the value of their interactions through trust and transparency.
3. Generating patient-based evidence through patient registries, mobile apps, and other tools can provide cost-effective, patient-relevant data to inform decision making.
The document summarizes a presentation on managed entry agreements for high-cost innovative pharmaceuticals. It discusses the issues of assessing value for money given uncertainty around health effects and budget impact. It defines managed entry agreements and performance-based risk-sharing agreements as formal arrangements to address these issues. While these schemes aim to improve access to innovative treatments, the evidence on their effectiveness is limited and implementation has proven difficult, particularly for outcomes-based arrangements. Overall, more structured evaluation is still needed but these schemes may help address challenges posed by high-priced drugs when traditional reimbursement is not suitable.
Improving the development of diagnostics testsMarilia Costa
1) Rapid diagnostic tests have great potential to improve healthcare in low- and middle-income countries by enabling accurate and timely treatment, but many barriers currently limit their development and deployment.
2) Key barriers include insufficient prioritization of diagnostics, financial challenges, demanding technical requirements, shortcomings in evaluation methods, complex regulatory systems, lack of quality assurance, and inadequate involvement of private healthcare providers.
3) Potential solutions involve prioritizing diagnostics development globally and nationally, using economic incentives, promoting locally-driven design, strengthening regulatory frameworks and quality assurance, engaging private providers, and developing flexible tools to support surveillance and differential diagnosis.
The document provides an overview of innovation and intellectual property (IP) processes at Alberta Health Services (AHS). It discusses definitions of innovation in healthcare and the importance of innovation and IP for health systems. It outlines AHS' IP policy and the processes for evaluating, managing, and commercializing innovations and IP from conception through stages of development. This includes establishing an Innovation Portal for identifying and advancing innovations, and conducting health technology assessments. A case study on a LINAC-MR radiation therapy project demonstrates applying these processes and developing a commercialization plan for an AHS-owned innovation. The document aims to provide guidance to innovators on partnering with AHS to advance healthcare innovations.
This document introduces the team and project for Media4Patient. The project aims to improve clinical trial enrollment through a new digital platform using social media and mobile technologies. It outlines challenges with patient recruitment such as many trials not reaching full enrollment and patients being unaware of clinical trial options. It then discusses stakeholders in clinical trials and viewpoints from different groups. Finally, it performs a PESTEL analysis to examine political, economic, technological, legal, environmental and socio-cultural factors affecting the project.
Why RWE Matters to Payers: Incorporating RWE in Health Economic Analysis to M...Office of Health Economics
1. Real world data (RWD) collected outside clinical trials reflects outcomes in the real world. Real world evidence (RWE) generated from RWD can help understand effectiveness, maximize value for payers, and manage uncertainty given evolving research and development.
2. Managed entry agreements (MEAs) are used to formally incorporate RWD to manage product entry addressing uncertainty while maximizing payer value through performance-linked reimbursement or coverage with evidence development.
3. Challenges to the use of RWE include implementation burdens, governance of data collection and analysis, and methodological issues in dealing with less controlled real world data.
Clinical Trial Data Transparency: Explaining Governance for Public Data SharingHealth Data Consortium
Watch the webinar here: http://www.screencast.com/t/0lATKYlJ8
Dr. Chris Boone, then-VP in Avalere’s Evidence Translation and Implementation Practice, discussed clinical trial data transparency and considerations for governance and open data sharing. Clinical trials are extremely valuable as the primary data source for seeking regulatory approval of products. Historically, regulatory agencie have been the sole recipients of clinical trial data, butthere has been a recent push from various stakeholder groups to open access to clinical trial data to non-regulatory researchers as an act of ethical responsibility to patients, a contribution to public health, and a demonstrated commitment to advancing the science. Some of the barriers include developing a sound approach for de-identifying patient data, adopting universal clinical trial data format, and managing the proactive and non-selective access and security of clinical data once collected. Dr. Boone discusses rationales and benefits/risks of clinical trial transparency, responsible use of publicly sharing this data, barriers and legal implications, and reasonable data sharing models.
Discover more health data resources on our website at http://www.healthdataconsortium.org/
MCDA can help address some challenges in health technology assessment by systematically considering multiple criteria, such as health impacts, costs, equity and other value dimensions. Some countries have piloted the use of MCDA in HTA processes, but there are still open questions around which criteria and weights to use, how to incorporate opportunity costs and deal with uncertainty. While MCDA shows promise for improving transparency and decision-making in HTA, further work is needed to balance its benefits and costs for different healthcare systems.
All patients are different, and data collected during product development or Randomised Clinical Trials (RCT) does not always paint the full picture of everyday patients. RWE insights complement the manufacturing process and RCT findings, adding more value and providing real-world impact. While together data from the manufacturing process and RWD paint a fuller picture.
Due to the limitations of the study design, data from the manufacturing process and RCTs are inadequate for demonstrating an intervention’s long-term safety and effectiveness. Moreover, it is possible to compare multiple product or interventions in RWE.
SMi Group's Adaptive Designs in Clinical Trials conferenceDale Butler
This document summarizes an upcoming conference on adaptive designs in clinical trials taking place from April 20-21, 2015 in London. The conference will focus on topics such as Bayesian adaptive designs, subgroup selection in clinical trials, integrating real-world patient data into adaptive trials, and designing biomarker-driven multi-arm multi-stage cancer trials. Speakers will discuss challenges with adaptive designs and their use in different therapeutic areas like neurodegenerative diseases. Participants can also register for optional half-day workshops on April 22nd focusing on Bayesian clinical trial designs and navigating international regulatory landscapes for adaptive trials.
The PRIME scheme aims to foster the development of medicines that address major unmet medical needs. It provides early and enhanced regulatory support through scientific advice and accelerated assessment. Since launching in 2016, over 50% of requests have come from small-to-medium enterprises. Of the 177 requests received, 36 products have been granted eligibility, covering a wide range of therapeutic areas. Key benefits for eligible products include early regulatory advice, a dedicated contact point, and potential for accelerated review. After two years, PRIME continues to successfully promote the development of promising medicines focused on unmet needs.
OHE Lunchtime Seminar with Associate Professor Paula Lorgelly, Deputy Director, Office of Health Economics
From the Antipodes to the Motherland: reflections on HTA decision makers as budget takers and budget makers
EuroBioForum 2013 - Day 2 | Mark PoznanskyEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# REGIONAL PERSPECTIVES #
Ontario Genomics Institute, Canada:
Innovative Research, Innovative Translation
Dr Mark Poznansky
President and CEO Ontario Genomics Institute
=======================================
http://www.eurobioforum.eu
This document discusses a new drug development paradigm (NDDP) that aims to improve the efficiency and effectiveness of clinical drug development. It outlines several proposals that call for reforming the current drug development model, including using more modeling, adaptive trial designs, and integrating clinical trials into healthcare delivery systems. The NDDP proposes a more flexible framework with early patient/payer engagement, exploratory and confirmatory research phases using modern trial designs, and post-approval studies to establish relative value. Challenges for industry include conducting large simple trials, partnering to support more efficient trials, and having a clear evidentiary strategy tailored to different drug archetypes.
Real world evidence pharmaceutical industry-plPeter Le
This document discusses the challenges and opportunities of real-world evidence (RWE) in the pharmaceutical industry. It notes that while RWE from real-world data can help improve drug development, operations, and decision-making, there are also challenges to overcome. These include issues with data accessibility, analysis capacity, and balancing limited resources. However, RWE also presents opportunities to increase value, understand effectiveness beyond clinical trials, and gain business insights. Overall, RWE brings significant opportunities if pharmaceutical companies can address solvable challenges through leadership, governance, and transformation.
This document is a final project essay about language learning methods. It discusses how traditional behavioral learning approaches that focus on repetition and stimulus-response can be boring and demotivating for students. However, more constructivist approaches that engage students and allow them to construct their own understanding may lead to more meaningful learning. The essay also analyzes a play about a student experiencing bullying at school and lack of motivation due to his teacher-centered classroom, showing how alternative approaches could help. It concludes that teachers need new, student-centered methods and a supportive environment to improve learning outcomes and prevent issues like bullying.
همایش رازهای برنامه ریزی و کسب موفقیت در کنکور 93 چهارشنبه هفدهم مهرماه با ارائه ی مهندس احسان فارسی مقدم مشاور مجتمع رستگاران و مشاور ویژه ی گزینه دو در مجتمع غیردولتی رستگاران برگزار گردید
The document appears to be a collection of disjointed statements in Indonesian describing various past activities and experiences of the author. Some of the experiences mentioned include participating in scouts in junior high school, going swimming with their father, having a favorite pet that died, and taking selfies with friends after college. Many of the statements are incomplete or difficult to understand due to grammatical errors.
This document provides rules for making nouns plural in English. It presents 6 main rules for adding suffixes like -s, -es, -ies to make words plural based on their spelling. It also lists irregular plurals that are formed by changing spellings or staying the same in plural form. Examples are provided to illustrate each rule. The document concludes with a practice activity to test understanding of regular and irregular plural forms.
2015-12-11 UdM l’ETS en appui à la couverture sanitaire universelleReiner Banken
Présentation lors de la journée internationale de la couverture sanitaire universelle organisée par la Communauté étudiante de santé mondiale de l'Université de Montréal
Imran is feeling unwell and staying at home. He receives a sympathy card from his sister in Singapore wishing him well. Several friends visit Imran to take care of him - one brings soup and bakes treats, another offers to water plants and tidy his room, while another will fluff his pillow and straighten his sheets. The purpose of expressing sympathy is to comfort those who are unwell or troubled, and to let them know people care. Sympathy can be shown directly or through cards, messages, or emails.
Ultrabooks are lightweight, thin laptops that are designed to be highly portable and responsive. Intel first introduced Ultrabooks to compete with tablets by making laptops that were thin and lightweight like tablets but with better performance and full laptop functionality. Ultrabooks use solid-state drives instead of hard drives for improved performance and battery life. Key Ultrabook models include the Samsung ATIV Book Series, Dell XPS 12, ASUS Zenbook, and Apple MacBook Air, with Ultrabook sales growing significantly in recent years.
The document discusses the Trillium-II initiative to scale up use of patient summaries in Europe and globally. It aims to progress the International Patient Summary Standard and leverage existing work on patient summaries and interoperability assets from previous projects like Trillium Bridge. The initiative will focus on unlocking patient data through patient summaries, developing educational materials, and involving stakeholders to identify needs and enablers for successful implementation. The overall goal is to empower individuals and enhance health systems through use of interoperable patient summaries.
First eStandards conference Panel of the European SDO Platformchronaki
Introduction to panel where Standards Developing Organization and National Competence Centers discuss the scope of the European SDO platform reflecting on earlier presentations.
This document discusses health challenges related to demographic changes and well-being under the Horizon 2020 program. It provides an overview of the Health challenge including priorities to promote active and healthy aging, a whole life approach, scaling up research, and reducing health inequalities. The document reviews funding rules and evaluation criteria for Horizon 2020. It also provides details on specific calls within the 2016-2017 work program related to personalized medicine, including calls on population cohorts, ICT solutions for aging, robotics, virtual coaching, and in-silico trials.
MAST: a model for HTA-based assessment of telemedicine applicationsHTAi Bilbao 2012
This document describes MAST (Model for Assessment of Telemedicine), a multidisciplinary framework for assessing telemedicine applications. It was developed through a comprehensive process and aims to describe effectiveness and quality of care impacts of telemedicine. MAST consists of 3 stages: setting context, multidisciplinary assessment across clinical, economic, organizational and social domains, and assessing transferability. It is being empirically tested through large European projects and has supported over 25 trials. While time-consuming, MAST provides a standardized approach and ensures comparability. Feedback has been positive and several regions are adopting it, with revisions planned based on empirical results to establish MAST as a widely accepted methodology.
Operational research aims to apply analytical methods to improve decision-making and resource allocation in various fields, including health care. It originated during World War II to study military problems scientifically. Now, operational research techniques are used to identify issues in health programs, test solutions to address those issues, and evaluate changes made to programs. The goal is to generate practical evidence to improve implementation, effectiveness, efficiency and sustainability of programs. Common methods include simulation, optimization, and data analysis. Operational research requires collaboration between managers and researchers throughout the research process.
The document discusses a presentation on the Joint Clinical Assessment (JCA) process under the European HTA Regulation and how it may impact patient experience and involvement in HTA.
It begins with an introduction to the JCA process and an overview of a presentation by Sophie Werkö from the Swedish Agency for Health Technology Assessment on their experiences with JCA. It then discusses challenges and opportunities for patient involvement in JCA, including timely involvement, defining PICOs, and ensuring input from both European and national level patient groups.
Finally, it provides an overview of EUCAPA and HTA4Patients, two projects aimed at training and building capacity for patient representatives to participate in European HTA processes like JCA
Community and Governance Recommendations for the Future State of an e-infrast...e-ROSA
This document provides recommendations for developing an e-infrastructure to support open science in agri-food systems. It identifies key societal challenges around feeding the growing population, climate change, unhealthy diets, and environmental pressures. Three major trends are digital agriculture, new genetic techniques, and adopting a systems perspective. Recommendations focus on sharing data and models, connecting diverse data sources through standards, and facilitating collaboration across disciplines and sectors. Specific recommendations include establishing sustainable funding, aligning with the European Open Science Cloud, promoting open innovation, and developing large public-private partnerships for data-driven research. The overarching goal is to support evidence-based policymaking and address challenges through open, international cooperation.
Seeking value: Experience from the UK's National Institute for Health and Car...OECD Governance
This presentation was made by Tommy Wilkinson, United-Kingdom, at the 4th meeting of the Joint DELSA/GOV-SBO Network on Fiscal Sustainability of Health Systems, held in Paris on 16-17 February 2015.
Tripartite dimension of interaction of patients, regulators and industry (Jan...jangeissler
This document discusses the importance of interaction and partnership between patients, regulators, and industry in medicine research and development. It acknowledges that patient involvement enhances the quality of research, evidence, transparency, and mutual respect. The document outlines some challenges to interaction, including siloed thinking and lack of trust, and notes that EUPATI has helped improve collaboration but long-term sustainability is key. The objectives of the event are to share experiences of pilot projects involving these stakeholders and ensure their interaction is understood and trusted.
Evaluation of a health systems knowledge translation network for AfricaDavid Roger Walugembe
This study aims to evaluate the impacts of a knowledge translation network in Africa called KTNET. KTNET is a coalition of eight research groups working to increase the use of health research in policy and practice. The study will use mixed methods including interviews and document reviews to evaluate changes in knowledge translation capacity and the effects of KT activities. A conceptual framework based on models of knowledge transfer capacity and research utilization will guide the evaluation. Results will provide insight on building capacity for knowledge translation and promoting the use of research in decision making.
The role of the FAIR Guiding Principles in a Learning Health SystemMichel Dumontier
The document discusses how the FAIR Guiding Principles can help support clinical practice guidelines (CPGs) and the Learning Health System (LHS). The FAIR Principles aim to make digital resources more findable, accessible, interoperable, and reusable. Applying these principles to CPGs could facilitate their development, management, and use in a digital LHS. This could help fill gaps in evidence and better support personalized medicine. The document provides recommendations for making CPGs more FAIR to realize this vision.
The executive director provided an update on the activities and achievements of the Patient-Centered Outcomes Research Institute (PCORI) over the past few months. Key points included funding 50 pilot projects totaling $30.8 million to engage patients and stakeholders in research, finalizing the national research agenda, and relocating to a new office in Washington, D.C. The methodology committee delivered its first report on methodological standards for patient-centered outcomes research and plans to seek public comment on the report over the next few months before presenting it for board approval.
How Community Engagement Fits Into The Mission Of The National Center for Adv...SC CTSI at USC and CHLA
NCATS aims to catalyze biomedical innovation to improve human health. It focuses on developing and testing new interventions, demonstrating their effectiveness, and disseminating them to improve public health. NCATS emphasizes community engagement throughout the translational research process to ensure research addresses important health issues. Through programs like the CTSA consortium and ORDR, NCATS facilitates collaboration between researchers and patient communities. Moving forward, NCATS will focus on innovating community engagement methods and measuring their impact on research and outcomes.
Estrategia de gestión del conocimiento y comunicaciones (GCC)OPS Colombia
This presentation outlines a new Knowledge Management and Communications (KMC) strategy for PAHO/WHO approved by the Executive Management in August 2010. It provides background information on why a new strategy is needed, highlights the strategic goals and objectives of the strategy, and outlines next steps for implementation. The overarching principle of the strategy is to ensure technical excellence in PAHO's content production and high quality standards for information and communication products, projects, and services with easy and equitable access. The strategy aims to guide the organization in adopting practices, policies, standards and procedures for knowledge management and communications.
Real World Outcomes Across the AD (Alzheimer’s disease) Spectrum (ROADS) to B...Martin Pan
The document describes the Real World Outcomes Across the AD Spectrum (ROADS) topic, which aims to develop recommendations on appropriate outcome measures and data sources to characterize Alzheimer's disease across its spectrum in real-world settings. The project will define patient-relevant outcomes, identify data sources, and provide guidance on modeling disease progression using existing data. This will inform a subsequent prospective data collection effort to generate real-world evidence on AD and optimize care systems. The collaboration involves industry, academic, regulatory, HTA and patient organizations to ensure the work supports evaluation and access to new AD treatments.
Under Pressure : Kenneth Kruk's StrategyKenneth Kruk
Kenneth Kruk's story of transforming challenges into opportunities by leading successful medical record transitions and bridging scientific knowledge gaps during COVID-19.
MBC Support Group for Black Women – Insights in Genetic Testing.pdfbkling
Christina Spears, breast cancer genetic counselor at the Ohio State University Comprehensive Cancer Center, joined us for the MBC Support Group for Black Women to discuss the importance of genetic testing in communities of color and answer pressing questions.
Feeding plate for a newborn with Cleft Palate.pptxSatvikaPrasad
A feeding plate is a prosthetic device used for newborns with a cleft palate to assist in feeding and improve nutrition intake. From a prosthodontic perspective, this plate acts as a barrier between the oral and nasal cavities, facilitating effective sucking and swallowing by providing a more normal anatomical structure. It helps to prevent milk from entering the nasal passage, thereby reducing the risk of aspiration and enhancing the infant's ability to feed efficiently. The feeding plate also aids in the development of the oral muscles and can contribute to better growth and weight gain. Its custom fabrication and proper fitting by a prosthodontist are crucial for ensuring comfort and functionality, as well as for minimizing potential complications. Early intervention with a feeding plate can significantly improve the quality of life for both the infant and the parents.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
KEY Points of Leicester travel clinic In London doc.docxNX Healthcare
In order to protect visitors' safety and wellbeing, Travel Clinic Leicester offers a wide range of travel-related health treatments, including individualized counseling and vaccines. Our team of medical experts specializes in getting people ready for international travel, with a particular emphasis on vaccines and health consultations to prevent travel-related illnesses. We provide a range of travel-related services, such as health concerns unique to a trip, prevention of malaria, and travel-related medical supplies. Our clinic is dedicated to providing top-notch care, keeping abreast of the most recent recommendations for vaccinations and travel health precautions. The goal of Travel Clinic Leicester is to keep you safe and well-rested no matter what kind of travel you choose—business, pleasure, or adventure.
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)bkling
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
Gemma Wean- Nutritional solution for Artemiasmuskaan0008
GEMMA Wean is a high end larval co-feeding and weaning diet aimed at Artemia optimisation and is fortified with a high level of proteins and phospholipids. GEMMA Wean provides the early weaned juveniles with dedicated fish nutrition and is an ideal follow on from GEMMA Micro or Artemia.
GEMMA Wean has an optimised nutritional balance and physical quality so that it flows more freely and spreads readily on the water surface. The balance of phospholipid classes to- gether with the production technology based on a low temperature extrusion process improve the physical aspect of the pellets while still retaining the high phospholipid content.
GEMMA Wean is available in 0.1mm, 0.2mm and 0.3mm. There is also a 0.5mm micro-pellet, GEMMA Wean Diamond, which covers the early nursery stage from post-weaning to pre-growing.
We are one of the top Massage Spa Ajman Our highly skilled, experienced, and certified massage therapists from different corners of the world are committed to serving you with a soothing and relaxing experience. Luxuriate yourself at our spas in Sharjah and Ajman, which are indeed enriched with an ambiance of relaxation and tranquility. We could confidently claim that we are one of the most affordable Spa Ajman and Sharjah as well, where you can book the massage session of your choice for just 99 AED at any time as we are open 24 hours a day, 7 days a week.
Visit : https://massagespaajman.com/
Call : 052 987 1315
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...nirahealhty
The South Beach Coffee Java Diet is a variation of the popular South Beach Diet, which was developed by cardiologist Dr. Arthur Agatston. The original South Beach Diet focuses on consuming lean proteins, healthy fats, and low-glycemic index carbohydrates. The South Beach Coffee Java Diet adds the element of coffee, specifically caffeine, to enhance weight loss and improve energy levels.
Unlocking the Secrets to Safe Patient Handling.pdfLift Ability
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
1. Catalysing
knowledge
generation in
real-world
setting-
Current work at
INESSS
Reiner Banken, M.D. M. Sc. - Advisor to the CEO- Alliances and networks
Geneviève Plamondon, M.Sc. - Scientific professional- Innovation
Dima Samaha, Pharm D MAS - Advisor Innovation and external affairs
November 19th 2014
2. 2
Outline of the presentation
1. Quick presentation of INESSS
2. Advisory committee on HTA and innovative
technologies
3. Current work on knowledge generation in real-world
settings
4. The new approach proposed
5. Questions and discussion
3. 3
INESSS – 40 years of science
advice for decision-making
1972
1996
Conseil d’évaluation des
technologies de la santé
(1988)
Réseau de revue
d’utilisation des
médicaments
January, 19,
Agences d’évaluation
des technologies et
des modes d’intervention
en santé
Comité de revue
de l’utilisation des
médicaments
2000
Conseil consultatif
de pharmacologie
Conseil du
médicament
2003
2003
Institut national
d’excellence
en santé et en
services sociaux
Social Services
Clinical Practice
Guidelines
2009
2011
1988
1991
Medical Biology
Lab tests
4. 4
INESSS’ Mission
• The mission of the Institute is to promote clinical
excellence and the efficient use of resources in the
health and social services sector
Informing decisions at the macro, meso and
micro level in health care and social
services.
An Act respecting the Institut national d'excellence en santé et en
services sociaux http://bit.ly/m6QZqT
5. 5
INESSS assesses technologies and
health and social care interventions
HTA of drugs for listing purposes (new active substances, generics,
new formulations …)
HTA of laboratory tests for listing purposes
Full HTAs (health and social care interventions)
Optimal use guides
Clinical practice guidelines
Rapid HTAs
Collective prescriptions (in collaboration with MSSS)
Methodological tools
Community of Practice of Hospital-Based HTA
6. 6
HTA for drug listing purposes
Act respecting the INESSS article 7
If the Institute considers that the therapeutic value of a medication
has been established, it sends its recommendation to the
Minister after assessing:
1. the reasonableness of the price charged
2. the cost-effectiveness ratio of the medication
3. the impact that entering the medication on the list will have on
the health of the general public and on the other components of
the health and social services system
4. the advisability of entering the medication on the list, given the
purpose of the basic prescription drug insurance plan
http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/I_13_03/I13_03_A.html
7. 7
Advisory committee on HTA and
innovative technologies (CÉTI)
• Created in December 2012
• Advisory to the CEO
Objective: To promote a common understanding of the
challenges of introducing innovative technologies into the health
system, and to identify possible solutions to ensure consistency in
doing so, for the benefit of users
Composition: Representatives from patient and user groups, from the
health technologies industry, from the research and HTA communities,
from the economic development community, and managers of the
health and social services network (local, regional and national levels)
For more information: http://www.inesss.qc.ca/en/networks-andpartnerships/bridging-mechanisms/
advisory-committee-on-hta-and-innovative-technologies.html
8. 8
• The Committee’s work led to the first HTA and Innovative Technologies
Forum on December 3 2013
Focus on implementing a
more dynamic
assessment process
better suited to the
particularities of
innovative technologies
For more information: eti.inesss.qc.ca/2013+About
9. 9
CÉTI: current work and next steps
To optimise the generation of knowledge in real-world settings for
innovative technologies with the greatest potential for positive impacts on
patients and the health system
Objectives:
• To define the concepts related to the production of knowledge in real world
settings;
• To develop a method for generation of knowledge in real-world settings for
innovative technologies, including a method to identify and prioritise the most
promising technologies;
• To identify and discuss the operational and implementation challenges of the
proposed approach;
• To propose a framework for the production of knowledge in real-world settings;
• To promote and facilitate the use of this framework by different groups of
stakeholders
10. 10
Knowledge generation in real-world
settings
• The living lab approach has been explored based on the suggestions
of CÉTI members
“A living lab is a user-centric innovation environment, built on realistic
activities and research where all relevant partners are involved in open
processes, with objective to generate sustainable values for living lab
partners and stakeholders”1
• Among the key characteristics of living labs:
– Value is created through the collaboration of different stakeholders in
public-private-people-partnerships
– Users are involved as co-creators
– Activities take place in real-world environments
– The innovation process is open and iterative
1- Bergvall-Kåreborn, B., IhlströmEriksson, C., Ståhlbröst, A., et Svensson, J., A Milieu for Innovation - Defining Living
Lab, presented at the 2nd ISPIM Innovation Symposium, New York, december 6-9 2009, available at
https://pure.ltu.se/portal/files/3517934/19706123_Paper.pdf
11. 11
Progressive field evaluation
Premises:
Applies to technologies with a high potential for positive impacts on
patients and the health system and for which the added value could
be best verified in real-world settings
– Implies a clear definition of what qualifies as a promising
innovative technology, as well as a way to judge the plausibility of
the value proposition
Current work aim to develop an approach, but not its
implementation
The concept of progressive field evaluation in its actual form is NOT
linked to the reimbursement processes. However it bares some
similarities with what has been suggested for coverage with evidence
development.
12. Objectives:
• Align the value proposal of an
• Integrate the knowledge and the
• Identify optimal conditions and
• Collect information about the
12
Progessive field evaluation
innovative technology with the
needs of the users
experience of the partners involved
adapt the use of a technology
accordingly
effectiveness of a technology, as
well as contextual and
organizational elements relevant to
decision makers
Image adapted from the Living Lab Methodology Handbook, Ståhlbröst et Holst, 2012, available at
http://www.ltu.se/cms_fs/1.101555!/file/LivingLabsMethodologyBook_web.pdf
13. 13
A starting point for the progressive
field evaluation
Research protocol → methods
Projects are part of public
research (protocols are peer-reviewed
and results are
published)
Participative research designs
(user centered)
Research designs allow for
adjustments during the project
• Data generated is open by
default (with confidential
elements to be defined)
Innovation protocol → social contract
Project governance framework
Definition of the roles of each
partner
Agreement on the level of
interaction between the partners
Start and end of the project
Funding of the project
14. 14
How is the progessive field evaluation
different from other approaches?
• Evolving nature: the process fosters the adaptation of the use
of the technology according to the users’ “real” needs
• Co-responsibility: activities are influenced by all partners and
the decision making (within the project) is shared
• Co-production: knowledge is generated through the
participation and the commitment of all partners
• Transparency: the information is public (open data), the rules
are clear and known (innovation protocol) and the processes
are open
15. 15
Towards a learning health system
Health system
16. 16
Challenges for pharmaceuticals
• Defining the role and place of progressive field
evaluations in relation to the life cycle of drug
development and use
• Cohabitation between an open collaborative
approach with the rules and practice of regulation
and market access
• Trust between the health system, industry and
patients
• Links to other innovative initiatives such as adaptive
licensing and IMI Get Real
17. 17
Proposal for discussions
• What could be the contribution of progressive field
evaluations in the post-market space?
• Which would be the possible triggers for progressive field
evaluations in the post-market space ?
• What would be the contribution of progressive field
evaluations for improving the patient care and health system
performance?