Context-Aware Process Modelling for Medicinal Product Development

Zeynep Ozturk Yurt, Rik Eshuis, Anna Wilbik, I.T.P. Vanderfeesten

Research output: Chapter in Book/Report/Conference proceedingConference Article in proceedingAcademicpeer-review


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.

Original languageEnglish
Title of host publicationThe Practice of Enterprise Modeling
Subtitle of host publication14th IFIP WG 8.1 Working Conference, PoEM 2021, Riga, Latvia, November 24–26, 2021, Proceedings
EditorsEstefanía Serral , Janis Stirna , Jolita Ralyté , Jānis Grabis
Number of pages16
ISBN (Electronic)978-3-030-91279-6
ISBN (Print)978-3-030-91278-9
Publication statusPublished - Nov 2021
Event14th IFIP WG 8.1 Working Conference on the Practice of Enterprise Modelling - Online, Riga Technical University, Latvia
Duration: 24 Nov 202126 Nov 2021

Publication series

SeriesLecture Notes in Business Information Processing


Conference14th IFIP WG 8.1 Working Conference on the Practice of Enterprise Modelling
Abbreviated titlePoEM 2021
Internet address


  • Business process management
  • Conceptual modelling
  • Context-awareness
  • Enterprise modelling


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