Continuing Education
Our continuing education programme in the field of regulatory affairs provides you with state-of-the-art teaching content, enabling you to keep track of developments and requirements in the rapidly changing health tech sector.
CAS ETH in Regulatory Thinking
Regulatory thinking becomes a catalyst for innovation, market access and entrepreneurial excellence. It will serve as a springboard for strategists who want to play an active role in shaping the modern medical products of tomorrow. It teaches the basics and deepens them with cutting-edge innovation topics (artificial intelligence, digital therapeutics, companion diagnostics, new in-vitro diagnostics etc.).
Programme Structure and Content
The CAS ETH in Regulatory Thinking can be described as a "studium generale" that will promote you to a generalist in the field of regulation and certification. You will get an overview in a rapidly changing healthtech market and be able to identify and guide different specialists. The programme gives insight in the various disciplines in regulatory affairs activities and compiles these in a unique approach, defined as "Regulatory Thinking". The main topics are:
The course consists of 5 modules with a specific topic each that can be combined into the CAS Regulatory Thinking. Each module starts with an input lecture, reading material, and a group task, 2.5 weeks later the group tasks are presented and discussed during a three-day workshop. The combination of input lecture, group work, and workshop will ensure maximal learning efficiency in this complex field. In contrast to comparable, traditional courses, it does not focus on knowledge presentation only but embedded learning during regulatorycase and strategy discussions.
Tuition language(s): English
Credits: 15 ECTS credits
Module 1: Regulatory World– Navigating thru a changing complex landscape
Build your global regulatory compass for strategy, foresight, and market
access.
Module 2: Medical DeviceDevelopment - from the idea to approval
Turn ideas into compliant, market-ready devices with integrated strategies.
Module 3: In-vitro &Next-Gen Diagnostics - Data-driven Approaches
Advance novel diagnostics with IVDR-compliant, data-driven evidence
frameworks
Module 4: Software as amedical device & Digital Therapeutics - Regulation for Software Innovation
Align agile software development with compliance, security, and
reimbursement
Module 5: AI in HealthTech- regulatory object and tool
Master AI regulation and governance while leveraging it as innovation
driver.
The programme gives insight into the various disciplines in regulatory affairs. Participants become experts by learning how to set up and implement a regulatory strategy, which is at the heart of successfully managing the entire business development processfor a healthtech product.
You will
- understand different regulatory landscapes
- know how to set up design and development processes
- use and evaluate validation tools
- learn how to develop a clinical strategy
- know about different certification and reimbursement strategies.
Participants become experts by learning how to set up and implement a regulatory strategy, which is at the heart of successfully managing the entire business development process for a healthtech product. Regulatory Thinking can be applied to: Software as medical device, artificial intelligence, digital biomarkers, biotech, medical devices, in-vitro diagnostic devices, medicinal products and combination products.
The CAS is designed for physicians, health care providers, and professionals in start-ups, MedTech and pharma companies who want to specialize in clinical research utilising novel, digital technology.
The CAS ETH in Regulatory Thinking is designed for participants with a university degree in
• Medicine, veterinary medicine or dentistry
• Human movement sciences, food science or health science
• Mechanical engineering, electrical engineering or other natural sciences
• Pharmacy, Pharmacology or other courses relevant to the programme
• Entrepreneurs
Master's degree acknowledged by ETH or equivalent university degree. Professional experience relevant to the continuing education programme.
• Required language skills: English: C1 – external pageShow proficiency scales
• Language(s) of performance assessment: English
Start: 2027
Duration: 6 months
Application period: tbd
Location: ETH Zurich and online
Programme fee: will be announced soon
Organiser
Professor Jörg Goldhahn
Programme Director
Dr. DietmarSchaffarczyk
Course Leader
Contact
Dep. Gesundheitswiss. und Technol.
Leopold-Ruzicka-Weg 4
8093
Zürich
Switzerland