Digital therapeutics: where are we standing and what’s next in the EU and the US?

Janine Reudt-Demont is a partner with the full service law firm Niederer Kraft Frey (NKF) in Zurich, Switzerland. She specialises in complex regulatory and compliance matters concerning the life sciences and healthcare industries. Janine also counsels clients on questions of distribution, product liability and product safety laws, including recalls. Janine Reudt-Demont studied law at the University of Fribourg (Switzerland), where she graduated with an additional degree in European Community Law. After traineeships at a major Swiss law firm and at the District Court of Zurich, she passed the Swiss bar exam in 2010. Before joining Niederer Kraft Frey as counsel in March 2020, Janine worked for almost ten years in the Life Sciences / IP and litigation departments of another top-tier Swiss law firm. During this time, she completed her LL.M. studies at the University of New South Wales (Sydney, Australia) and was seconded as Legal and Compliance Officer with a pharmaceutical company, where she gained valuable industry insights.

Elisa Stefanini has an extensive experience in regulatory and compliance matters with a particular focus, in the last years, on all legal matters regarding pharmaceuticals and medical devices and other areas of Life Sciences. Her experience includes clinical trials, placing on the market, promotion and advertising of pharmaceuticals and medical devices, etc. She has also gained significant experience in matters of protection of personal data in the context of clinical trials, with particular regard to the processing of genetic data, including through biobanks. In addition, she often advises on Life Sciences regulatory matters in the context of M&A transactions. Elisa is ranked by Chambers Europe 2024, by The Legal 500 EMEA 2024, and by Who’s Who Legal in the Life Sciences 2024 and the Italy 2023 guides. She is the author of several publications in the field of biotechnology and scientific research. She is also author of numerous articles in magazines, including foreign ones, specialized in the life sciences sector. She participates in the capacity of speaker in numerous conferences and seminars in the field of Life Sciences.