Found 2 relevant results in 1.46s where lecturer="Verena Voelter"
Exploring SaMD, MD, IVD, ATMPs, and Pharma regulations, we contrast their approval requirements and PMS strategies, focus-ing on safety, performance, and biological / chemical complexity. We look at reimbursement issues and link them to regulatory ap-proval and market access strategies, including economic aspects of product lifecycle management.
Digital Health Technology (DHT) enables new study designs, including better evidence generation for value-based health care. This module focuses on the preparation of a study synopsis incorporating a digital technology and/or modern study concept.