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.

Anna Amich is a Director of Device and Digital Safety at AstraZeneca, where she oversees the Clinical Evaluation and Investigation process for medical devices. With a MSc in Clinical Trials Monitoring, and a PG Certificate in Epidemiology, Anna brings over 20 years of extensive experience in ensuring the safety of pharmaceutical and medical device products, both pre- and post-market introduction. Before her current role, Anna held key roles at Novartis, she served as the EU QPPV deputy and PRRC officer. Prior to her time at Novartis, Anna contributed to the Patient Safety department at Alcon Laboratories. Anna is a member of the Team-PRRC organization and serves as a designated expert by UNE.

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.