Eva von Mühlenen

EVA VON MÜHLENEN heads Sidley’s Swiss Life Sciences practice and advises pharmaceutical, MedTech and biotechnology companies on regulatory and contentious matters across the product lifecycle. Drawing on 14 years of frontline regulatory experience at Swissmedic, the Swiss Agency for Therapeutic Products, she brings a first-hand perspective on Switzerland’s life sciences regulatory framework.

Eva supports life sciences companies on regulatory strategy and compliance relating to medicinal products and medical devices, including clinical development, product authorization, manufacturing compliance and Good Manufacturing Practice (GMP), regulatory inspections, market access and post-market oversight. She represents clients in proceedings before Swissmedic and the Swiss courts and assists with pricing, reimbursement and market access matters, including proceedings before the Federal Office of Public Health (FOPH) and the Swiss frameworks governing the reimbursement of medicinal products. A recognized authority on digital health, Eva advises companies on the regulatory implications of artificial intelligence and machine learning in healthcare, as well as on digital and data strategies, including data protection, privacy and cybersecurity.

Eva is actively involved in the development of digital health policy and research. She served as an advisor to the Swiss National Science Foundation’s National Research Programme 77 on Digital Transformation and is a member of the expert panel of the Institute of Neurotechnology & Law (INL). She also lectures on life sciences regulation and digital health at leading Swiss universities, including ETH Zurich, the University of Zurich and the Lucerne University of Applied Sciences and Arts (HSLU).