In the ETH CAS Regulatory Thinking continuing education programme, experts in the field will teach you how to transform a research idea. The experts will navigate you through different regulatory landscapes and how to develop convincing certification strategies for different healthtech products.

Participants of this ETH CAS Regulatory Thinking become certification 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.

Professional perspectives:

The ETH CAS Regulatory Thinking can be described as a “studium generale” that makes YOU a generalist in the field of regulation and certification. YOU will keep an overview in a rapidly changing healthtech market and be able to identify and guide different specialists. Regulatory generalists are increasingly in demand in the health sector: whether as an executive seeking to drive a business forward, a government official seeking to ensure the safety of health products, a payer defining new reimbursement pathways.

Structure and format:

The programme consists of seven modules that guide participants through the definition of regulatory thinking to a business and certification strategy for healthtech products.

- Introduction Regulatory World
- Regulatory Thinking & Landscapes
- Product Definition & Classification
- Development Process: Pre-clinical
- Set-up Production
- Development Process: Pre-clinical
- Approval, Certification & Post Market Activities
- Reimbursement Strategies & other Success Factors

Target group:

The CAS ETH in Regulatory Thinking is aimed at (non-) healthcare professionals who want to master the regulatory challenges in a rapidly changing heathtech market.
Regulatory Thinking can be applied to

• Medicinal Products
• Medical Devices
• Software as a Medical Device
• Digital Biomarkers
• In vitro Diagnostic Devices
• Biotech
• Combination Products

 

Details
  • September 1, 2023 @ 8:00 am
  • June 1, 2024
  • Zürich
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