EVA VON MÜHLENEN advises on complex legal and regulatory matters across the life sciences spectrum, drawing on her broad experience and in-depth knowledge of Swiss regulations, as well as the administrative procedures involved in manufacturing, authorizing, marketing and advertising of medicinal products and medical devices. In addition, she advises on matters concerning digital health, including the application of artificial intelligence and machine learning software in healthcare. She also advises on digital and data strategies, including data protection, privacy, and cybersecurity issues. Eva co-leads Sidley’s benchmarking group for in-house MedTech lawyers (mtlegal). Eva’s practice covers the pharmaceutical, medical device, MedTech and biotechnology industries on both advisory and contentious matters.
Prior to joining Sidley, Eva served with Swissmedic, the Swiss Agency for Therapeutic Products, as Deputy Head of the Legal Advice Department and as Legal Advisor to the agency’s Digital Transformation Initiative SMC 4.0. During her 14 years at Swissmedic, she advised both internal and external stakeholders on all issues relating to the legal and regulatory framework regarding therapeutic products, including clinical trials, product authorization, licensing, market access and surveillance. In addition, Eva was deeply involved in ICT-related matters, including all issues regarding Swissmedic’s electronic submission system, including digital signature, cybersecurity, data protection aspects and cloud solutions.
Eva has represented Swissmedic as lead counsel in litigation before the Swiss Federal Administrative Court and the Swiss Federal Supreme Court. She also served as project manager responsible for developing and revising Swiss regulations, including to achieve alignment with new EU regulations.
Eva is a thought leader on digital health issues, currently serving as an advisor to the Swiss National Science Foundation’s National Research Programme 77 on “Digital Transformation”, which is charged, in cooperation with the Federal Institute of Technology Zurich (ETHZ), with developing a policy roadmap for digital health innovation. She has also recently authored a paper on “Trustworthy Digitalization - A Digital Transformation Strategy.”
Earlier in her career, Eva worked in private practice both in Germany and Switzerland, helping clients in the life science and food processing sector in M&A transactions and on strategic decisions within the regulatory frameworks, including advertising and promotional issues. She is a law graduate of the University of Heidelberg, Germany, and the University of Bern, Switzerland, and recently completed a Certificate of Advanced Studies (CAS) for Inhouse Counsel at the University of Zurich’s Europa Institut.