Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

Introduction:In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Union. Methods: We established a cohort of medicinal products with aRMMs at marketing authorisation (MA) that were centrally authorised from July 2012–December 2021 using the European Public Assessment Reports. Evaluation studies were identified from the Risk Management Plans at the time of MA. Subsequently, we retrieved protocols, final study reports, Pharmacovigilance Risk Assessment Committee (PRAC) assessment reports, and PRAC minutes. We calculated the probability of completing an effectiveness evaluation within 60 months after MA using time-to-event analyses. Besides, we compared the planned final report with the actual final report date. Results: We identified 134 medicinal products authorised with aRMMs, of which almost half (n = 63, 47.0%) had an effectiveness evaluation study. The probability of an evaluation for a medicinal product being completed within 60 months after MA was 20.7% (95% CI 6.8–32.6). Regarding study design, the probability of completing a study was higher for cross-sectional studies when compared to cohort studies (p = 0.002). Moreover, 81.0% of studies were delayed when compared to their planned final report date. Conclusion: The probability of completing an aRMM effectiveness evaluation at time for renewal of the MA was only one in five. Furthermore, estimates of the duration of studies around MA are too optimistic, with the majority being delayed.</p

Using Customer Segmentation to Build a Hybrid Recommendation Model

Camacho, P., de Almeida, A., & António, N. (2021). Using Customer Segmentation to Build a Hybrid Recommendation Model. In J. V. de Carvalho, P. Liberato, Á. Rocha, & A. Peña (Eds.), Advances in Tourism, Technology and Systems - Selected Papers from ICOTTS20 (pp. 299-308). (Smart Innovation, Systems and Technologies; Vol. 208). Springer Science and Business Media Deutschland GmbH. https://doi.org/10.1007/978-981-33-4256-9_27The growing trend in leisure tourism has been closely followed by the number of hospitality services. Nowadays, customers are more sophisticated and demand a personalized and simplified experience, which is commonly achieved through the use of technological means for anticipating customer behavior. Thus, the ability to predict a customer’s willingness to buy is also a growing trend in hospitality businesses to reach more customers and consolidate existing ones. The acquisition of a transfer service through website reservation generates data that can be used to perform customer segmentation and enable recommendations for other products or services to a customer, like recreation experiences. This work uses data from a Portuguese private transfer company to understand how its private transfer business customers can be segmented and how to predict their behavior to enhance services cross-selling. Information extracted from the data acquired with the private transfer reservations is used to train a model to predict customer willingness to buy, and based on it, offer leisure services to customers. For that, a hybrid classifier was trained to offer recommendations to a customer when he/she is booking a transfer. The model employs a two-phase process: first, a binary classifier asserts if the customer who’s buying the transfer would eventually buy a service experience. In that case, a multi-class model decides what should be the most likely experience to be recommended.authorsversionpublishe

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021

Introduction: In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be properly balanced with the quality of the study. We assessed the duration of aRMM effectiveness evaluations, using additional pharmacovigilance activities, for centrally authorised medicinal products in the European Union. Methods: We established a cohort of medicinal products with aRMMs at marketing authorisation (MA) that were centrally authorised from July 2012–December 2021 using the European Public Assessment Reports. Evaluation studies were identified from the Risk Management Plans at the time of MA. Subsequently, we retrieved protocols, final study reports, Pharmacovigilance Risk Assessment Committee (PRAC) assessment reports, and PRAC minutes. We calculated the probability of completing an effectiveness evaluation within 60 months after MA using time-to-event analyses. Besides, we compared the planned final report with the actual final report date. Results: We identified 134 medicinal products authorised with aRMMs, of which almost half (n = 63, 47.0%) had an effectiveness evaluation study. The probability of an evaluation for a medicinal product being completed within 60 months after MA was 20.7% (95% CI 6.8–32.6). Regarding study design, the probability of completing a study was higher for cross-sectional studies when compared to cohort studies (p = 0.002). Moreover, 81.0% of studies were delayed when compared to their planned final report date. Conclusion: The probability of completing an aRMM effectiveness evaluation at time for renewal of the MA was only one in five. Furthermore, estimates of the duration of studies around MA are too optimistic, with the majority being delayed

Designing Luxury Experience

In luxury brand management, experiences are essential. However, most of what we know about designing customer experiences originates from work developed with and/or for mass brands. Luxury brands are conceptually different and require a specific approach to brand management. Using a grounded theory approach, we present a framework consisting of seven principles to design luxury experience. Our research suggests that to create a true luxury experience brands should go beyond traditional frameworks of brand management. By compiling best practices and the commonalities amongst the interviewed companies' most successful efforts to create a luxury experience, the framework can help brands to implement a trading-up strategy: Luxury brands can enhance their desirability by offering a true luxury experience and non-luxury brands can adopt principles of luxury experience and become life-style brands

Service Interaction Flow Analysis Technique for Service Personalization

Abstract Service interaction flows are difficult to capture, analyze, outline, and represent for research and design purposes. We examine how variation of personalized service flows in technology-mediated service interaction can be modeled and analyzed to provide information on how service personalization could support interaction. We have analyzed service interaction cases in a context of technology-mediated car rental service. With the analysis technique we propose, inspired by Interaction Analysis method, we were able to capture and model the situational service interaction. Our contribution regarding technology-mediated service interaction design is twofold: First, with the increased understanding on the role of personalization in managing variation in technology-mediated service interaction, our study contributes to designing service management information systems and human-computer interfaces that support personalized service interaction flows. Second, we provide a new analysis technique for situated interaction analysis, particularly when the aim is to understand personalization in service interaction flows

Managing by design

This editorial written by myself and Marc Gruber of EPFL. It explores the role of design thinking in the management of large organisations, and focuses on how design principles can be applied to the design of the workplace and the nature of work itself. As Head of Service Design at the RCA, my contribution is on how to apply design thinking methods for managers and the 6 key elements described in this approach In the last decade the importance of design and the value of design thinking as a tool for innovation has been recognized by both business and government. Design has become a strategic tool for business helping to translate technological innovation into user value, connecting with consumer needs and creating compelling product and service experiences that create new business value. In this paper we consider a further application of design thinking by considering how managers can apply it to the design of the workplace experience. Many enterprises, especially those in the knowledge economy, are defined by their human resources and their capacity to attract and retain talent. In this competitive environment the design of the employee experience and the services that support them and enable them to deliver value to the clients and colleagues, is a key differentiator. Applying design thinking to the design of work itself, the systems that support it, and the physical and virtual environments in which it takes place can help business and organizational leaders to attract and retain top talent, as well as to enhance productivity and operational effectiveness. In this paper we explore the key factors and principles by which leaders and managers can apply design thinking to transform the workplace experience and we propose 6 key elements for managers to enable that transformation and enhance social capital and business and organisational performance

Multi-factor service design: identification and consideration of multiple factors of the service in its design process

Service design is a multidisciplinary area that helps innovate services by bringing new ideas to customers through a design-thinking approach. Services are affected by multiple factors, which should be considered in designing services. In this paper, we propose the multi-factor service design (MFSD) method, which helps consider the multi-factor nature of service in the service design process. The MFSD method has been developed through and used in five service design studies with industry and government. The method addresses the multi-factor nature of service for systematic service design by providing the following guidelines: (1) identify key factors that affect the customer value creation of the service in question (in short, value creation factors), (2) define the design space of the service based on the value creation factors, and (3) design services and represent them based on the factors. We provide real stories and examples from the five service design studies to illustrate the MFSD method and demonstrate its utility. This study will contribute to the design of modern complex services that are affected by varied factors

An Integrative Design Framework for New Service Development

Service innovation is focused on customer value creation. At its core, customer-centric service innovation in an increasingly digital world is technology-enabled, human-centered, and process-oriented. This requires a cross-disciplinary, holistic approach to new service design and development (NSD). This paper proposes a new service strategy-aligned integrative design framework for NSD. It correlates the underlying theories and principles of disparate but interrelated aspects of service design thinking: service strategy, concept, design, experience and architecture into a coherent framework for NSD, consistent with the service brand value. Application of the framework to NSD is envisioned to be iterative and holistic, accentuated on continuous organizational and customer learning. The preliminary framework's efficacy is illustrated using a simplified telecom case example. © Springer International Publishing Switzerland 2014