CAS ETH in Regulatory Thinking
Regulatory Work: A creative frontier at ETH Zurich
In a pioneering initiative, the Department of Health Sciences and Technology at ETH Zurich launched in autumn 2023 the CAS ETH in Regulatory Thinking (CAS RT) a year ago, setting a new benchmark in continuing education. Unlike traditional regulatory affairs programmes, this curriculum covers a comprehensive range of health technology products, including medical devices, pharmaceuticals and combination products. The essence of this programme is to use regulatory thinking as a business tool, emphasising the critical impact of an intelligent regulatory strategy on the success or failure of a product.
Participants in this programme become innovators or healthtech analysts, equipped with essential skills such as problem solving and the ability to formulate clinical development plans and a reimbursement strategy. From the outset, knowledge transfer is seamlessly integrated into the programme, ensuring that participants are ready to apply their learning in real-world scenarios: They culminate their studies by presenting bespoke regulatory strategies tailored to their products.
Ten months later, the first cohort has successfully completed the programme. The atmosphere is one of pride and deep commitment, with participants impressed by their journey.
• Mateo, a start-up co-founder, reflects: "The programme helped me develop the right mindset to approach regulatory strategy.
• Tiffany, a project portfolio manager at Wyss, says: "Great learning from experts with hands-on experience. I also enjoyed learning of the expertise from the other participants".
• José, a medical doctor specialising in orthopaedic surgery and traumatology, remarks: "Regulatory Thinking is the missing link in university research.
The recent final meeting, held at the Probstei Wislikofen on 28 and 29 July, was a testament to the success of the programme: A weekend of exceptional presentations and lively discussions showcased Regulatory Thinking's creative yet compliant approach to business development. Discussions covered a wide range of healthcare products, from DiGAs and medical fluids to SaMDs, IVD platforms, imaging and surgical planning tools, ATMPs and medical devices.
As we celebrate the achievements of our graduates, we look forward to their continued success in their careers. The CAS ETH in Regulatory Thinking has not only equipped them with regulatory expertise, but has also fostered a creative and strategic mindset that is essential for driving innovation in healthtech.