“Imagine you are founding a university spin-off with the goal of bringing a medical device or gene therapy to market. When should a Quality Management System (QMS) be implemented?”
With this targeted question, our Quality Management & Regulatory Affairs team opened the EKFZ Academy workshop on “Implementing a Quality Management System for Combination Products,” immediately highlighting how crucial it is to implement a QMS early in the development process. A well-established QMS bridges the gap from laboratory research to market launch and is essential for complying with regulatory requirements and managing risks. Fenja Hanneken and Mohamad Mersalli guided participants through the processes and procedures required for the introduction and implementation of a QMS in an academic spin-off, shedding light on the quality requirements for both gene therapies and medical devices. In this context, they explained the challenges and synergies arising from linking different regulatory requirements with the structures of academic institutions. Following the interactive workshop, participants had the opportunity to discuss open questions with the speakers – while enjoying an ice cream in the warm summer weather.
A big thank you to the entire Quality Management & Regulatory Affairs team for this insightful workshop; we are already looking forward to further joint training sessions!
