Regulatory Thinking

• The participants 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: Regulatory world; Regulatory Thinking (RT); Development process: Pre-clinical; Production (GMP); Development process: Clinical; Approuval/Post market activities; Success factors.
• 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. 

Direct admission with:

• Master's degree acknowledged by ETH or  equivalent educational qualifications 
• Professional experience relevant to the continuing education programme.
• English: C1

For further information on accreditation, please see the provider’s website.
 

CHF 13'900.-. For further information on costs, please see the provider’s website.

The programme is currently being revised. (summer 2026)