Focus Regulatory Affairs & Clinical Development

A Unique Industry-Oriented Qualification Profile

This specialization provides students with a qualification profile that is unique in Germany and specifically tailored to the needs of the life sciences industry. Students are systematically prepared for responsible positions throughout the entire product development process — from clinical research and monitoring to regulatory affairs and approval strategies, as well as the development of medical devices and in vitro diagnostics (IVDs). The programme emphasizes how these areas interact seamlessly in real-world practice.

Practice-Oriented Learning with Case Studies and Industry Cases

Teaching is strongly practice-oriented and based on realistic case studies, typical industry scenarios, and authentic workflows. Students learn how clinical trials are designed and planned, how efficacy and safety evidence is methodically assessed, and how a coherent regulatory strategy is developed and structured. The practical relevance of the programme is ensured by lecturers with extensive industry and clinical experience and is further strengthened through the guidance of an industry advisory board.

Understanding the Entire Path from Innovation to Approval

Students learn to approach products holistically throughout their entire life cycle — from the initial concept to regulatory approval. This includes understanding regulatory requirements, generating and evaluating evidence, managing risks, structuring technical documentation, and developing a compelling regulatory storyline that enables innovations to become successful market-ready products.

Career Opportunities for Graduates

Graduates of this specialization pursue careers in a wide range of roles across the product development pathway, including positions such as Clinical Research Associate (CRA), Regulatory Affairs Manager, Medical Writer, Quality Manager, or Product Manager. Excursions and exchange opportunities through an active alumni network support students in building valuable professional connections early in their careers.