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.

Susanne Winterscheid is biologist and started at the BfArM in the variation section after a few years of employment in pharmaceutical industry. Since 2005 she was heading the Project Management of a licensing division at BfArM. Since 2008 she is Chair of the Joint CMD working party for variations. In November 2011 she has become the German member of the CMDh. Since June 2015 she is Head of Licensing Division 3 at BfArM.