Designing democratic institutions for collaborative economic development: a European perspective

Collaborative approaches to local economic development have developed in a number of European countries. However collaborative working presents a new problem for policy makers and public management researchers. The problem is to design an institutional framework for the governance of economic development that provides for anchorage in the democratic system without loosing the benefits of flexible policy design and delivery. This is particularly important in a European context. The European Union has recognised the need for citizens to be more engaged in the governance of public policy at all scales - from local neighbourhoods to the transnational level. This chapter addresses the problem by examining the basic questions that any form of democratic governance design needs to address, and relating this to the case of economic development. The core democratic design questions are: How can legitimacy be secured? In what ways can relevant publics give consent to decisions? Through what means can the institution be held to account? The chapter discusses these three democratic imperatives and shows that different responses to these produce three archetypical governance designs - club, agency and polity. We then explore the way in which the problems of democratic governance have been solved empirically through longitudinal case studies of the expansion of Mainport Rotterdam and the management of economic, environmental, residential and transportation agendas in the Ghent canal area of the Flanders region of Belgium. The analysis shows that although different national and regional political contexts matter, the typology of archetypes offers a way of understanding the overall democratic orientation of a particular governance design as well as offering a basis from which policy makers can create their own solutions

Flexible Resolution of Authorisation Conflicts in Distributed Systems

Flexible Resolution of Authorisation Conflicts in Distributed System

A Formal Approach to Specification, Analysis and Implementation of Policy-Based Systems

The design of modern computing systems largely exploits structured sets of declarative rules called policies. Their principled use permits controlling a wide variety of system aspects and achieving separation of concerns between the managing and functional parts of systems. These so-called policy-based systems are utilised within different application domains, from network management and autonomic computing to access control and emergency handling. The various policy-based proposals from the literature lack however a comprehensive methodology supporting the whole life-cycle of system development: specification, analysis and implementation. In this thesis we propose formally-defined tool-assisted methodologies for supporting the development of policy-based access control and autonomic computing systems. We first present FACPL, a formal language that defines a core, yet expressive syntax for the specification of attribute-based access control policies. On the base of its denotational semantics, we devise a constraint-based analysis approach that enables the automatic verification of different properties of interest on policies. We then present PSCEL, a FACPL-based formal language for the specification of autonomic computing systems. FACPL policies are employed to enforce authorisation controls and context-dependent adaptation strategies. To statically point out the effects of policies on system behaviours, we rely again on a constraint-based analysis approach and reason on progress properties of PSCEL systems. The implementation of the languages and their analyses provides us some practical software tools. The effectiveness of the proposed solutions is illustrated through real-world case studies from the e-Health and autonomic computing domains

Authentication and authorisation in entrusted unions

This paper reports on the status of a project whose aim is to implement and demonstrate in a real-life environment an integrated eAuthentication and eAuthorisation framework to enable trusted collaborations and delivery of services across different organisational/governmental jurisdictions. This aim will be achieved by designing a framework with assurance of claims, trust indicators, policy enforcement mechanisms and processing under encryption to address the security and confidentiality requirements of large distributed infrastructures. The framework supports collaborative secure distributed storage, secure data processing and management in both the cloud and offline scenarios and is intended to be deployed and tested in two pilot studies in two different domains, viz, Bio-security incident management and Ambient Assisted Living (eHealth). Interim results in terms of security requirements, privacy preserving authentication, and authorisation are reported

An Architecture for Provenance Systems

This document covers the logical and process architectures of provenance systems. The logical architecture identifies key roles and their interactions, whereas the process architecture discusses distribution and security. A fundamental aspect of our presentation is its technology-independent nature, which makes it reusable: the principles that are exposed in this document may be applied to different technologies

Architecture for Provenance Systems

This document covers the logical and process architectures of provenance systems. The logical architecture identifies key roles and their interactions, whereas the process architecture discusses distribution and security. A fundamental aspect of our presentation is its technology-independent nature, which makes it reusable: the principles that are exposed in this document may be applied to different technologies

The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland

© 2019 Keyter, Salek, Banoo and Walker.Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders’ demands. The aims of this study were to compare the registration process and the regulatory review model of the South African Medicines Control Council (MCC) to that of four other similar-sized regulatory authorities and to identify areas for improvement that may inform recommendations to the South African Health Products Regulatory Authority (SAHPRA) as it looks to re-engineer and enhance the registration process in South Africa. Methods: A questionnaire describing the organisational structure, the registration process, good review and decision-making practices of the MCC was completed by the author (AK) for the purpose of this study and validated by the Registrar of the MCC. Similar questionnaires were also completed and validated by Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, Singapore’s Health Science Authority (HSA) and Switzerland’s Swissmedic. Results: A comparison of the MCC regulatory process with the four comparative agencies indicated that they all have similar requirements and employ a full-review model although the timelines for the MCC were considerably longer. However, similar quality measures were implemented by all authorities as part of their good review practices (GRevP) including prioritising transparency, communication, continuous improvement initiatives and training. Conclusion: Comparisons made through this study provided insight into the areas of the MCC registration process that may be improved and have informed recommendations to SAHPRA including the implementation of facilitated regulatory pathways, definition of targets for key milestones in regulatory review and formal implementation and monitoring of GRevP. In order to build quality into the review process the application of a standardised template for the clinical assessment of medicines such as the Universal Methodology for Benefit-Risk Assessment (UMBRA) could be considered as well as enhancing transparency and communication through the application of an electronic management system and the development of publicly available summaries for the basis of approval.Peer reviewedFinal Published versio

Evidence of comparative efficacy should have a formal role in European drug approvals

Despite methodological concerns, comparative efficacy evidence should be required at the time of drug approval, says Corinna Sorenson and colleagues, to allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives