Stratified Medicines Innovation Platform, Graham Bell

M. Luisetto Pharm.D.Spec. Pharmacology

Ward pharmacist economical assessment and actions, management tools , innova...

The document discusses the role of clinical pharmacists in managing drug costs through various tools and approaches. It outlines systematic approaches that pharmacists can take including prioritizing management strategies, conducting budget impact analyses of medication costs, setting cost containment targets, selecting high-cost therapy management projects, implementing formulary management policies, and monitoring costs. Clinical pharmacists with specialized training can be dedicated to cost management projects through collaborative working groups.

Jornadas #PatientInHTA · Valentina Strammiello

This document discusses the involvement of patients and consumers in the work of the European Medicines Agency (EMA). It outlines how: 1) EMA has increasingly involved patients and consumers since 1995, with over 770 instances of involvement in 2016 across activities like scientific committees, benefit-risk discussions, and guidelines development. 2) Involving patients requires resources from organizations like EURORDIS, including staff time equivalent to 1.5 full-time employees and over 280 days volunteered in 2016 on EMA scientific committees. 3) While patient involvement has grown, there are still barriers like availability of advocates, balancing industry relationships, and integrating patient perspectives in regulatory timelines. Further steps are exploring ways to better

Why pharmacovigilance

OnlineCompliance Panel

The document discusses the increasing importance and complexity of Phase IV or post-market studies, which are FDA-mandated studies of approved drugs. Phase IV studies are likely to be large in scale with 500,000 patients per arm and have exacting endpoints. They are obligatory and help answer important safety questions. With increasing complexity of drugs, Phase IV studies are essential to identify any unexpected adverse events or toxicities as early as possible. The objectives of Phase IV studies include understanding different types of post-market studies, safety monitoring plans, defining rare adverse events, and the role of data monitoring committees in large studies.

Rare disease day - feb 29th 2016 - Eilish Hardiman

ipposi

The document discusses the current model of genetic service delivery in Ireland and the need for a National Genomic Medicine Network. It describes the existing genetics department and testing laboratories located at Our Lady's Children's Hospital in Crumlin. It identifies key factors that require changes to the model like new technologies, networked services, user advocacy, electronic healthcare records, and mainstreaming genetics into general medicine. The document proposes a National Genomic Medicine Network structured across the health service and academia to provide a national model for genetic testing. It recommends multidisciplinary teams and an office for rare diseases to direct access to services within and outside Ireland, supported by ICT to enable networked care and research.

EUPATI Launch Meeing: Anders Olauson

jangeissler

This document discusses the need for a paradigm shift in public understanding of medical research and development (R&D) to better meet patient needs. It notes that current "success stories" only help small numbers of patients, and that patients urgently need therapeutic innovation. It argues that innovation in areas like cancer, rare diseases, clinical trial design, and personalized medicine requires new approaches in R&D. It also emphasizes the important role patient organizations can play by providing insights into patient experiences and priorities to help drive research. Finally, it introduces the European Patients' Academy as an initiative aiming to train patient advocates and foster collaborative efforts to make drug development more effective.

Health System Consortium Investigates Cost of Medical Device Variation

Tom McNaull

Thomas McNaull graduated from the Harvard Business School’s program for Owners/Presidents. He earned a MBA from Emory University and a BSBA with emphasis in Accounting from the University of Florida. He has managed the financial operations of health care organizations such as American MedTrust and the Abu Dhabi Health Services Company. In 2007, Thomas McNaull drew on his extensive experience to found MedStar and, as managing director, oversees the delivery of financial advisory services to client health care systems and physician groups.

Jornadas #PatientInHTA · Iñaki Imaz

Jornadas #PatientInHTA · Ana Toledo

Data Governance for Real-World Evidence: Cross-country differences and recomm...

This document analyzes data governance frameworks for using real-world data (RWD) to generate real-world evidence (RWE) in eight countries. It identifies 29 elements of an ideal governance framework and assesses each country's framework against these criteria. Recommendations include having clear data protection laws that allow secondary uses of health data to benefit patients, using opt-out consent for large cohort data collection, and transparent data linkage mechanisms with national interoperability standards. Current country frameworks show varying adherence to these recommendations.

Multi-Indication Pricing: Do we want it? Can we operationalize it?

Albert Einstein Cancer Center

This document discusses multi-indication pricing (MIP), an innovative pricing scheme where medicines can be priced differently for different approved indications. MIP aims to set prices that better reflect the value of a drug across its indications. The document outlines MIP frameworks, reviews international examples, and discusses challenges to implementing MIP in the UK healthcare system. Key challenges include whether the NHS can handle variable net prices by indication and monitor usage data. International experience shows MIP being used with different brands of the same drug or through sub-national pricing schemes. MIP warrants further exploration but requires collaboration across stakeholders and consideration of data and pricing model options.

Towards better health outcomes: Experiences and conclusions from the MCHP

MCH-org-ua

This document summarizes experiences and conclusions from the MCHP (Maternal and Child Health Program) on improving health outcomes. It discusses implementing a quality of care framework at the facility and health systems levels, including modernizing infrastructure, promoting continuous medical education focused on practical skills, integrating new evidence into care through clinical practice guidelines and protocols, and putting patients at the center. It also covers using information systems to drive change and governance through management training and decentralization to strengthen institutions. The outlook calls for developing a more team-oriented and learning culture oriented towards patient needs through knowledge sharing and integrating new knowledge on an ongoing basis.

Session 3.1 Libutti

The document outlines the vision and strategies for a new cancer care center. The center aims to provide outstanding cancer care for patients while advancing scientific understanding of cancer through translational research. It will establish a multidisciplinary, disease-based care model and develop new treatments to reduce cancer deaths and suffering. The center plans to expand clinical services and research collaborations, build a biospecimen repository, and pursue affiliations and outreach to support its growth.

HTA's 'Macro' Role in Health Care Systems

'THE RIGHTS OF “RARE”' by Dr. Wendy Lipworth - Sick or Treat Sessions

RareCancersAustralia

This document discusses the challenges of accessing medicines for rare cancers from an ethical perspective. It notes that while there is a desire to help patients with rare cancers, decisions around access are difficult as there are competing values to consider, such as safety, equity, efficiency, affordability and having strong scientific evidence. These values can conflict with each other, such as the need for quick access versus the need for high-quality evidence. The document recommends that advocacy for access should focus on procedural justice and ensuring all stakeholders are engaged, decisions are made transparently, and there is accountability in the decision making process.

Assured Clinical Insight - Health In4matics 2012

BredaCorish

1) Elsevier is a large provider of scientific and medical information. They produce clinical tools and resources for UK healthcare practitioners like MD Consult and Clinical Key. 2) UK hospital doctors face challenges of keeping up with information and managing clinical overload. They consult online sources several times a week to support patient care but often find Google faster than clinical search engines or journals. 3) Clinical Key is Elsevier's solution, powered by their taxonomy of over 250,000 clinical concepts. It aims to provide faster search and more intuitive browsing through "smart content" tagging to help doctors spend less time searching and more with patients.

Jornadas #PatientInHTA · Paloma Casado

The document summarizes the Spanish Network of Health Technology Assessment (HTA) Agencies, which provides a consolidated model for collaborative work across Spain's decentralized healthcare system. The Network aims to inform decision making on health technologies through coordinated assessments across regions to promote equity and sustainability. It is comprised of HTA agencies from each autonomous region, coordinated by the Ministry of Health. The Network collaborates on an annual work plan and common methodology to prioritize assessments, avoid duplication of efforts, and share results.

EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...

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.

EUPATI 2013 Conference: Patient involvement in medicines R&D: Bringing to li...

M. Luisetto Pharm.D.Spec. Pharmacology

The Role of Patients & their Challenges in Clinical Trials

Kathi Apostolidis

Medical devices and pharmaceutical care 2014 N.42

Chapter 1 what is statistics

Ibrahim El-Torbany

This document outlines the syllabus for MST 103 - Introduction to Statistics and Probability, a 3-credit course taught on Sundays from 9-11 am by Professor Ahmed HassenYoussef. The textbook is Statistical Techniques in Business and Economics with Global Data sets. The goals of the course are to understand descriptive and inferential statistics, distinguish between variable types, and understand the four levels of measurement. Statistics is defined as the science of collecting, organizing, analyzing, and interpreting numerical data to assist with decision making.

Chapter 8 - Introduction to Probability and Statistics

Muhammad Bilal Khairuddin

This chapter discusses probability and statistics concepts including counting principles, permutations, combinations, sample spaces, events, and probability calculations. It covers topics such as the basic counting principle, permutations of objects with and without repetition, combinations, determining sample spaces and events for experiments, and calculating probabilities for events in finite sample spaces, including using combinations and factorials. Examples include finding the number of possible routes between cities, quiz answer arrangements, poker hands, and probabilities of coin toss or dice roll outcomes.

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Jornadas #PatientInHTA · François Houyez

Why pharmacovigilance

OnlineCompliance Panel

Rare disease day - feb 29th 2016 - Eilish Hardiman

ipposi

EUPATI Launch Meeing: Anders Olauson

jangeissler

Health System Consortium Investigates Cost of Medical Device Variation

Tom McNaull

Jornadas #PatientInHTA · Iñaki Imaz

Jornadas #PatientInHTA · Ana Toledo

Data Governance for Real-World Evidence: Cross-country differences and recomm...

Multi-Indication Pricing: Do we want it? Can we operationalize it?

Albert Einstein Cancer Center

Towards better health outcomes: Experiences and conclusions from the MCHP

MCH-org-ua

Session 3.1 Libutti

HTA's 'Macro' Role in Health Care Systems

'THE RIGHTS OF “RARE”' by Dr. Wendy Lipworth - Sick or Treat Sessions

RareCancersAustralia

Assured Clinical Insight - Health In4matics 2012

BredaCorish

Jornadas #PatientInHTA · Paloma Casado

EUPATI 2013 Conference: Building Knowledge & Competences for Patients’ Involv...

EUPATI 2013 Conference: Vision on Patient involvement in medicines R&D: Here...

EUPATI 2013 Conference: Patient involvement in medicines R&D: Bringing to li...