Context-Aware Process Modelling for Medicinal Product Development

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.