This description is only available in English.

  • tba

    Start
  • 10 months
    Duration
  • ETH Zurich, online

    Location
  • English
    Tuition language
  • 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

15 ECTS 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

Language(s) of performance assessment

English

Dates and venue

Start

tba

Duration

10 months

Application period

tba

Location

ETH Zurich and online

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

Organiser

Programme management

Professor Jörg Goldhahn
Programme Director
Professor Jörg Goldhahn
Maria Murillo
Programme Coordinator
Maria Murillo

Contact

Maria Murillo
Programme Coordinator CAS ETH in Regulatory Thinking
  • +41 44 633 61 87

ETH Zurich
D-HEST
Leopold-Ruzicka-Weg 4
8093 Zurich

Responsible body

ETH Zurich, D-​HEST
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