CAS ETH in Regulatory Thinking
This description is only available in English.
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tba
Start -
10 monthsDuration
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ETH Zurich, online
Location -
EnglishTuition language
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tba
Application period -
CHF 13,900
Programme fee
In brief: The CAS ETH in Regulatory Thinking
Learning to use regulatory thinking as a business development tool for healthtech products.
Structure and content
Programme description
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: Regulatory world; Regulatory Thinking (RT); Development process: pre-clinical; Production (GMP); Development process: clinical; Approuval/Post market activities; Success factors.
Objectives
The programme gives insight in 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 process for 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.
Professional perspectives
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.
Structure and format
The course is organised in a modular way built on each other. Each module includes input lectures, followed by blended learning and onsite workshop with all participants and lecturers to discuss specific course content and progress in study planning.
Tuition language(s)
English
Credits
Target group and admission
Target group
The CAS ETH in Regulatory Thinking is designed for persons 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
Requirements
Master's degree acknowledged by ETH or equivalent university degree. Professional experience relevant to the continuing education programme.
Required language skills
English: C1 – external page Show proficiency scales
Language(s) of performance assessment
Dates and venue
Start
tba
Duration
Application period
tba
Location
Fees
Programme fee
CHF 13,900
Application fee
CHF 50 for persons with a Swiss university degree, CHF 150 for persons with another university degree (non-refundable, credit card payment only)
Withdrawal fee
- Within 30 days after the admission date: free of charge
- More than 30 days after the admission date: CHF 6,585
- After the start of the programme: CHF 13,900
Application
Questions about the application
ETH Zurich, School for Continuing Education, HG E 17–18.5, Rämistrasse 101, 8092 Zurich, Tel. external page +41 44 632 56 59, E-mail
Application documents
- Diploma certificate and transcript (of records) of the highest or most relevant degree
- Passport or identity card
- Download Declaration of consent (PDF, 94 KB)
Organiser
Programme management
Contact
ETH Zurich
D-HEST
Leopold-Ruzicka-Weg 4
8093
Zurich