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A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?
In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA) recommendation for centralized marketing authorization.
Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations.
This study identified European national reimbursement recommendations for 102 new active substances (NASs) approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy) and HTA recommendations. However, there was less alignment between the HTA processes and recommendations.
In order to move forward to a more harmonized HTA environment within Europe, it is first necessary to understand the variation in HTA practices within Europe. This study has identified alignment between HTA recommendations and the System taxonomy and one of the major implications of this study is that such alignment could support a more collaborative HTA environment in Europe.
Journal Article
Design roots : culturally significant designs, products, and practices
Design Roots provides a comprehensive review of culturally significant designs, products and practices which are rooted to particular communities through making tradition and a sense of place. Many rich traditional practices associated with community, tacit knowledge and culture are being rapidly lost due to globalization and urbanization. Yet they have much to offer for the future in terms of sustainability, identity, wellbeing and new opportunities in design. This book considers the creative roots, the place-based ecologies, and deep understandings of cultural significance, not only in terms of history and tradition but also in terms of locale, social interactions, innovation, and change for the sustainment of culturally significant material productions.
Book
A Metric for the Entropic Purpose of a System
Purpose in systems is considered to be beyond the purview of science since it is thought to be intrinsically personal. However, just as Claude Shannon was able to define an impersonal measure of information, so we formally define the (impersonal) ‘entropic purpose’ of an information system (using the theoretical apparatus of Quantitative Geometrical Thermodynamics) as the line integral of an entropic “purposive” Lagrangian defined in hyperbolic space across the complex temporal plane. We verify that this Lagrangian is well-formed: it has the appropriate variational (Euler-Lagrange) behaviour. We also discuss the teleological characteristics of such variational behaviour (featuring both thermodynamically reversible and irreversible temporal measures), so that a “Principle of Least (entropic) Purpose” can be adduced for any information-producing system. We show that entropic purpose is (approximately) identified with the information created by the system: an empirically measurable quantity. Exploiting the relationship between the entropy production of a system and its energy Hamiltonian, we also show how Landauer’s principle also applies to the creation of information; any purposive system that creates information will also dissipate energy. Finally, we discuss how ‘entropic purpose’ might be applied in artificial intelligence contexts (where degrees of system ‘aliveness’ need to be assessed), and in cybersecurity (where this metric for ‘entropic purpose’ might be exploited to help distinguish between people and bots).
Journal Article
A Hyperbolic Sum Rule for Probability: Solving Recursive (“Chicken and Egg”) Problems
We prove that the probability of “A or B”, denoted as p(A or B), where A and B are events or hypotheses that may be recursively dependent, is given by a “Hyperbolic Sum Rule” (HSR), which is relationally isomorphic to the hyperbolic tangent double-angle formula. We also prove that this HSR is Maximum Entropy (MaxEnt). Since this recursive dependency is commutative, it maintains the symmetry between the two events, while the recursiveness also represents temporal symmetry within the logical structure of the HSR. The possibility of recursive probabilities is excluded by the “Conventional Sum Rule” (CSR), which we have also proved to be MaxEnt (with lower entropy than the HSR due to its narrower domain of applicability). The concatenation property of the HSR is exploited to enable analytical, consistent, and scalable calculations for multiple hypotheses. Although they are intrinsic to current artificial intelligence and machine learning applications, such calculations are not conveniently available for the CSR, moreover they are presently considered intractable for analytical study and methodological validation. Where, for two hypotheses, we have p(A|B) > 0 and p(B|A) > 0 together (where “A|B” means “A given B”), we show that either A,B is independent or A,B is recursively dependent. In general, recursive relations cannot be ruled out: the HSR should be used by default. Because the HSR is isomorphic to other physical quantities, including those of certain components that are important for digital signal processing, we also show that it is as reasonable to state that “probability is physical” as it is to state that “information is physical” (which is now recognised as a truism of communications network engineering); probability is not merely a mathematical construct. We relate this treatment to the physics of Quantitative Geometrical Thermodynamics, which is defined in complex hyperbolic (Minkowski) spacetime.
Journal Article
The Handbook of Design for Sustainability
Sustainability has emerged as a central issue for contemporary societies and for the world community as a whole. Furthermore, many of the social and environmental concerns that are embodied in the term ‘sustainability’ are directly or indirectly related to design. Designers help to define our human made environment - how it is produced, how it is used, and how long it endures. Despite some forty years of development and increased awareness of the critical relationships that exist between design decisions and modes of production, energy use, environmental impacts, the nature of work and human exploitation, design for sustainability is still not widely understood or followed. The Handbook of Design for Sustainability presents a comprehensive, state-of-the-art overview of this crucial subject - its development, its methods, its practices and its potential futures. Bringing together leading international scholars and new researchers to provide a substantive insight into the latest thinking and research within the field, The Handbook covers a breadth of historical and theoretical understandings and includes a series of original essays that explore methods and approaches for designers and design educators. The Handbook presents the first systematic overview of the subject that, in addition to methods and examples, includes historical perspectives, philosophical approaches, business analyses, educational insights and emerging thinking. It is an invaluable resource for design researchers and students as well as design practitioners and private and public sector organizations wishing to develop more sustainable directions.
eBook
Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries
Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and effective medicines and vaccines by the 15 countries in the Economic Community of West African States region. Although this project has made significant progress towards the realisation of its goals, challenges still remain. The aims of this study were to evaluate the effectiveness and efficiency of the WA-MRH, examine what challenges are being encountered and identify strategies that would strengthen the process for realising the initiative’s goals. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from assessors representing the seven active NMRAs in the joint assessment procedure that identified the benefits, challenges and recommendations for improving the performance of the WA-MRH project. Results: The benefits of the joint assessment procedure include time savings to manufacturers resulting from submitting one dossier and the same response package to multiple countries resulting in access to the multiple African markets within the same timeframe. Additionally, some of the NMRAs have been able to strengthen their technical capacity as a result of this initiative. Key challenges to the project include the lack of a robust information technology system that would enable dossier tracking and constraints in human resources needed to support dossier submissions and the assessment process. Conclusion: This study identified the strengths of the WA-MRH initiative as well as strategies for improvement and achievement of its objectives. The centralised submission of a dossier and its tracking is key to the regulatory assessment process. This research has demonstrated that amongst other considerations, a robust information technology system, coupled with the necessary human resource capacity would greatly enhance the effectiveness and efficiency of the WA-MRH initiative.
Journal Article
Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward
Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspect pharmaceutical manufacturing sites and streamline decision-making processes. This initiative enables the cost-effective use of limited resources and efficient and effective delivery of regulatory services to be determined, thus instilling transparency and accountability in all stakeholders, optimising the pharmaceutical market and economic development and improving access to safe, high-quality, effective medicines in the region. The aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative, including challenges faced and to identify opportunities for improvement. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire, which was used to identify the benefits, challenges, and suggestions for improving performance of EAC-MRH initiative, was completed by assessors representing seven EAC authorities in the joint assessment procedure. Semi-structured interviews were also carried out to validate the responses. Results: This initiative has been of considerable value as it moves toward achieving its main objectives of shorter timelines for approval of medicines, information sharing among regulators and capacity building for assessments, resulting in quicker access and increased availability of medicines for patients in the region. However, the key challenges identified that have hindered effectiveness and efficiency were the lack of a centralised submission and tracking system; inadequate human resources, manufacturers’ failure to submit the exact same dossier to all countries of interest; lack of an integrated information management system; lack of information on national medical regulatory authority or EAC websites; and challenges in monitoring and tracking assessment reports. Conclusion: The use of a robust information technology system for the central tracking of EAC products is essential to address the identified challenges and improve regulatory effectiveness and efficiency. One central point for payment is needed to expedite the process and to ensure transparency and the availability of information on decision making on national and regional websites. Other key strategies for enhancement include improving the capacity of assessors, work and information sharing and a coordination mechanism for the regional joint assessment, with the eventual establishment of a regional medicine agency.
Journal Article