BPM Support for Regulatory Compliance in ATMP Development Processes

Advanced Therapy Medicinal Product(ATMP) development processes are associated with inefficiencies due to lack of an efficient and effective management methods that can support scientists in working towards regulatory compliance. This research addresses this problem by proposing refined solutions based on knowledge-intensive Business Process Management(BPM). Here, methods will be developed to support scientists in planning a development process that is compliant with regulations. These methods will be based on the knowledge on process modelling, goal modelling and context-aware business processes. Thereby, this project will provide an exemplary approach for supporting compliance management in knowledge intensive processes. The methods will be implemented in a software and evaluated through a real-life ATMP development case.