Experiences of generating COTS components when automating medicinal product evaluations

This paper reports on experiences of generating COTS components when designing and deploying component based software architecture for automation and interoperation of medicinal product evaluations across different countries in the world. Our generic architectural model renders two sets of software components that are candidates for COTS components. We identify which role such COTS components may play and outline our approach of generating them. We advocate that such COTS components are developed with a specific component platform in mind and must adhere to constraints of our software architecture

Developing a database for automating regulatory affairs in the pharmaceutical industry

The complex procedure of processing the marketing authorization of medicinal product licenses is a challenging task for government health authorities and the pharmaceutical industry across the world. Regulatory requirements have diverged significantly, and each country has its own regulations and procedures for marketing authorizations. The automation of and adequate software support for such procedures are critical factors that can improve the efficiency of regulatory authorities. In this paper we report on the design and implementation of a database whose role is to (a) support the automation of marketing authorization procedures, (b) address the interoperability of such procedures across the world, and (c) be reusable across a family of related applications. Our database is implemented in Oracle8i, and a distributed and component-based application has been built upon it using the J2EE technology

Design patterns for automation of marketing authorisations in pharmaceutical industry

This paper reports on the experiences of using existing and creating new design patterns when deploying layered and component based software architecture that automates procedures for marketing authorization. We use the strategy pattern within the generic architecture and deploy the architectural components with the Model-View-Controller (MVC) and front controller patterns. Three domain specific patterns have been created and named as: look-up, submission and evaluation. We advocate that our combination of general and domain specific patterns (i) facilitate the design of distributed software applications, (ii) can be reused in any problem domain where workflows similar to submission and evaluations of application licenses occur, and (iii) comprise commercial-off-the-shelf (COTS) components that fit within our software architecture

Kinematics and Robot Design II (KaRD2019) and III (KaRD2020)

This volume collects papers published in two Special Issues “Kinematics and Robot Design II, KaRD2019” (https://www.mdpi.com/journal/robotics/special_issues/KRD2019) and “Kinematics and Robot Design III, KaRD2020” (https://www.mdpi.com/journal/robotics/special_issues/KaRD2020), which are the second and third issues of the KaRD Special Issue series hosted by the open access journal robotics.The KaRD series is an open environment where researchers present their works and discuss all topics focused on the many aspects that involve kinematics in the design of robotic/automatic systems. It aims at being an established reference for researchers in the field as other serial international conferences/publications are. Even though the KaRD series publishes one Special Issue per year, all the received papers are peer-reviewed as soon as they are submitted and, if accepted, they are immediately published in MDPI Robotics. Kinematics is so intimately related to the design of robotic/automatic systems that the admitted topics of the KaRD series practically cover all the subjects normally present in well-established international conferences on “mechanisms and robotics”.KaRD2019 together with KaRD2020 received 22 papers and, after the peer-review process, accepted only 17 papers. The accepted papers cover problems related to theoretical/computational kinematics, to biomedical engineering and to other design/applicative aspects

The drivers of Corporate Social Responsibility in the supply chain. A case study.

Purpose: The paper studies the way in which a SME integrates CSR into its corporate strategy, the practices it puts in place and how its CSR strategies reflect on its suppliers and customers relations. Methodology/Research limitations: A qualitative case study methodology is used. The use of a single case study limits the generalizing capacity of these findings. Findings: The entrepreneur’s ethical beliefs and value system play a fundamental role in shaping sustainable corporate strategy. Furthermore, the type of competitive strategy selected based on innovation, quality and responsibility clearly emerges both in terms of well defined management procedures and supply chain relations as a whole aimed at involving partners in the process of sustainable innovation. Originality/value: The paper presents a SME that has devised an original innovative business model. The study pivots on the issues of innovation and eco-sustainability in a context of drivers for CRS and business ethics. These values are considered fundamental at International level; the United Nations has declared 2011 the “International Year of Forestry”

Safety and Reliability - Safe Societies in a Changing World

The contributions cover a wide range of methodologies and application areas for safety and reliability that contribute to safe societies in a changing world. These methodologies and applications include: - foundations of risk and reliability assessment and management - mathematical methods in reliability and safety - risk assessment - risk management - system reliability - uncertainty analysis - digitalization and big data - prognostics and system health management - occupational safety - accident and incident modeling - maintenance modeling and applications - simulation for safety and reliability analysis - dynamic risk and barrier management - organizational factors and safety culture - human factors and human reliability - resilience engineering - structural reliability - natural hazards - security - economic analysis in risk managemen

Resolving semantic conflicts through ontological layering

We examine the problem of semantic interoperability in modern software systems, which exhibit pervasiveness, a range of heterogeneities and in particular, semantic heterogeneity of data models which are built upon ubiquitous data repositories. We investigate whether we can build ontologies upon heterogeneous data repositories in order to resolve semantic conflicts in them, and achieve their semantic interoperability. We propose a layered software architecture, which accommodates in its core, ontological layering, resulting in a Generic ontology for Context aware, Interoperable and Data sharing (Go-CID) software applications. The software architecture supports retrievals from various data repositories and resolves semantic conflicts which arise from heterogeneities inherent in them. It allows extendibility of heterogeneous data repositories through ontological layering, whilst preserving the autonomy of their individual elements. Our specific ontological layering for interoperable data repositories is based on clearly defined reasoning mechanisms in order to perform ontology mappings. The reasoning mechanisms depend on the user‟s involvments in retrievals of and types of semantic conflicts, which we have to resolve after identifying semantically related data. Ontologies are described in terms of ontological concepts and their semantic roles that make the types of semantic conflicts explicit. We contextualise semantically related data through our own categorisation of semantic conflicts and their degrees of similarities. Our software architecture has been tested through a case study of retrievals of semantically related data across repositories in pervasive healthcare and deployed with Semantic Web technology. The extensions to the research results include the applicability of our ontological layering and reasoning mechanisms in various problem domains and in environments where we need to (i) establish if and when we have overlapping “semantics”, and (ii) infer/assert a correct set of “semantics” which can support any decision making in such domains