Maren von Fritschen is a recognized leader in Regulatory Affairs with 20+ years in Pharma and MedTech. With a PhD in Natural Sciences, she's now Head of Regulatory Policy Europe at Moderna, driving regulatory strategies for innovative technologies like mRNA. Maren built the regulatory arm at EUCOPE and was a foundational force behind PharmaLex, later founding AddOn Pharma as CEO. She's chaired DIA's Regional Advisory Council EMEA, contributed to TOPRA, and the STARS project. In the academic realm she is lecturing and mentoring master students at the University of Applied Sciences. Additionally, she has established a comprehensive scientific network across leading Universities in Brazil, focusing on medication in primary health care.

Graduated in Physics (PhD), initial research area thin film technologies, then neurostimulation. As leader of the implant team developed innovative cochlear implants including conformity assessment of the CI-system, This device was the first medical device in AT to be CE-marked. Achieved market approvals in most markets. From 2004 to 2019 with the Austrian Authority (BASG, Federal Office for Safety in Healthcare) as Senior Expert, member of various MDEG Was and MDCG. Since 2020 active as consultant and trainer.

Graduated in Technical Engineering (Dr. techn.), University Assistant Institute for Biomedical Engineering Technical University Graz, Quality Management Siemens-Matsushita Components, Test Engineer for Medical Devices TÜV Austria. Member of various medical Device working groups (EU and national level), Lecturer at the University of Applied Sciences Linz and Vienna, Author. Since 1996 with the Federal Ministry for Health (BMSGPK) dealing with Regulatory Issues concerning Medical Devices, current Position Head of Department.