Context-Aware Process Modelling for Medicinal Product Development

Yurt, Zeynep Ozturk; Eshuis, Rik; Wilbik, Anna; Vanderfeesten, Irene

doi:10.1007/978-3-030-91279-6_12

Cited by 3 publications

(3 citation statements)

References 21 publications

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“…In this paper, we extend our prior paper [9] in several ways. First, we present a meta-model that explains and integrates the concepts we use to model context-aware medicinal product development processes in the case study.…”

Section: Introductionmentioning

confidence: 83%

“…This paper first presents an explorative case study, initially presented in a prior conference paper [9], in which context-aware enterprise models are used to support ATMP scientists in managing the regulatory aspects more efficiently and effectively. The object of the case study is the biomaterial development process, which is a part of ATMP development processes, from the Horizon2020 iPSpine project.…”

Section: Introductionmentioning

confidence: 99%

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Context-aware modeling for knowledge-intensive medicinal product development processes

et al. 2022

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Due to their unique characteristics, knowledge-intensive processes (KiPs) are difficult to capture with conventional modeling and management approaches. One such KiP is the advanced therapy medicinal product (ATMP) development process. ATMPs are highly innovative medicinal products that are based on biomedical technology. ATMP development processes need to comply with complex regulatory frameworks. Currently, biomedical scientists that develop ATMPs manage the regulatory aspects of the ATMP development processes in an ad hoc fashion, resulting in inefficiencies such as reworks or even withdrawal of ATMPs from the market. This paper presents an explorative case study in which we use Enterprise Modeling and Context-aware Business Processes to support ATMP scientists in managing the regulatory aspects of ATMP development processes more efficiently and effectively. In our explorative case study, we use enterprise models to describe the important concepts and views in ATMP development processes. By introducing context-awareness to the models, we support ATMP scientists in performing relevant tasks to address the regulatory requirements efficiently and effectively under different contexts. We introduce the novel concept of execution-dependent dynamic context to properly define the context in ATMP development processes. Additionally, this paper takes a broader perspective on the case study by discussing the relevance of the solutions derived for the case study for other KiPs. Thereby this paper aims to present an exemplary approach for context-aware modeling of KiPs. The practical contribution of this paper are the models realized in a real-life ATMP development project. The scientific contribution of this paper is providing an exemplary approach for supporting knowledge workers who perform flexible, KiPs under dynamic contexts and introducing the notion of execution-dependent dynamic context.

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Section: Introductionmentioning

confidence: 83%

Section: Introductionmentioning

confidence: 99%

Context-aware modeling for knowledge-intensive medicinal product development processes

et al. 2022

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“…Contextual goal models are introduced in requirements engineering literature [1]. Existing approaches can be used to derive the input contextual goal model [1,17]. First, the goals that will be modeled in the process model are selected.…”

Section: Methods For Integrated Modeling Of Kips With Contextual Goalsmentioning

confidence: 99%

A Method for Integrated Modeling of KiPs and Contextual Goals

Yurt

Eshuis

Aysolmaz

et al. 2022

Cooperative Information Systems

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Knowledge-intensive processes (KiPs) progress in a flexible way towards the achievement of process goals. Contextual factors like location and regulations affect how these goals are achieved in KiPs. Conventionally, a context is considered to be either static or dynamic. For some KiPs part of the context can be dynamic, meaning that the context can change during the execution of the KiP as a result of the decisions and interpretations of the knowledge-worker based on the information gained throughout the process. A holistic approach linking dynamic context, goals and processes is vital for modeling such KiPs. This paper presents a method, based on enterprise models, for integrated modeling of KiPs with contextual goals under dynamic contexts. With our method, we guide business analysts in modeling complex, flexible KiPs under dynamic contexts.

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