%0 Conference Proceedings
%T Context-Aware Process Modelling for Medicinal Product Development
%+ Eindhoven University of Technology [Eindhoven] (TU/e)
%+ Maastricht University [Maastricht]
%+ Open Universiteit Nederland [Heerlen]
%A Ozturk Yurt, Zeynep
%A Eshuis, Rik
%A Wilbik, Anna
%A Vanderfeesten, Irene
%Z Part 3: Business Process Modeling and Management
%< avec comité de lecture
%@ 978-3-030-91278-9
%( Lecture Notes in Business Information Processing
%B 14th IFIP Working Conference on The Practice of Enterprise Modeling (PoEM)
%C Riga, Latvia
%Y Estefanía Serral
%Y Janis Stirna
%Y Jolita Ralyté
%Y Jānis Grabis
%I Springer International Publishing
%3 The Practice of Enterprise Modeling
%V LNBIP-432
%P 168-183
%8 2021-11-24
%D 2021
%R 10.1007/978-3-030-91279-6_12
%K Context-awareness
%K Enterprise modelling
%K Business process management
%K Conceptual modelling
%Z Computer Science [cs]
%Z Humanities and Social Sciences/Library and information sciencesConference papers
%X Advanced Therapy Medicinal Products (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 rework, or even withdrawal of ATMPs from the market if the regulatory requirements are not adequately addressed. This paper presents an explorative case study in which we investigate enterprise modelling and context-aware business processes to support ATMP scientists in managing the regulatory aspects of ATMP development processes more efficiently and effectively. The main objective of this case study is to offer regulatory-based guidance to scientists. We use enterprise models (domain, goal and process models) to describe the important concepts and views in ATMP development processes. By introducing context-awareness to the models, we enable regulatory-based guidance that supports ATMP scientists in performing relevant tasks to address the regulatory requirements efficiently and effectively.
%G English
%Z TC 8
%Z WG 8.1
%2 https://inria.hal.science/hal-04323850/document
%2 https://inria.hal.science/hal-04323850/file/514409_1_En_12_Chapter.pdf
%L hal-04323850
%U https://inria.hal.science/hal-04323850
%~ SHS
%~ IFIP
%~ IFIP-TC
%~ IFIP-LNBIP
%~ IFIP-WG
%~ IFIP-TC8
%~ IFIP-WG8-1
%~ IFIP-POEM
%~ IFIP-LNBIP-432