Found 8 relevant results in 1.06s where lecturer="Dietmar Schaffarczyk"
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.
Participants will learn the essentials of remote monitoring and the use of other digital health technologies in clinical trials. This includes key technology, selection of devices, integration into trials, and subsequent data management. Concepts and devices will be presented, and participants have the chance to learn about challenges with hands-on workshops and direct interactions with experts.
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.
Translational science is a cross disciplinary scientific research that is motivated by the need for practical applications that help people (e.g. Medicines). The course should help to clarify basics of translational science, illustrate successful applications and enable students to integrate key features into their future projects.
From software as a medical device to medicinal products: The intended use of a healthtech product serves as strategic pivotal point from conception to reimbursement strategies: Understanding its importance defines advertising claims and ensures that the product meets the needs of patients.
Tailored medical treatments based on disease characteristics but also on patients’ individual features is becoming clinical routine. Personalised medicine utilises genetic, environmental and lifestyle factors to optimise approaches in healthcare. The use of AI will be essential to enhance personalised medicine to improve patients’ journey from diagnosis to treatment and the outcome.
Students gain an overview of how to transform a research idea into a finished healthtech product by confidently navigating different regulatory landscapes and developing compelling certification strategies for various healthtech products. Students learn how to use Regulatory Thinking to turn Regulatory Affairs into a business planning tool.
Participants will be introduced into regulations and landscape including all stake holders. The different types of medicinal products are introduced including subsequent regulations. Participants apply the knowledge in different starting scenarios.