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Abstract
Students gain an overview of how to transform a research idea into a finished healthtech product by confidently navigating different regulatory landscapes and developing compelling certification strategies for various healthtech products. Students learn how to use Regulatory Thinking to turn Regulatory Affairs into a business planning tool.
Objective
- Applying of regulatory thinking and translation of this method into practice. - Getting an overview of applicable laws, different regulations, directives and guidelines in the healthtech sector: MD, IVD, SaMD, medicine, biotech, ATMP. - Understanding the different roles and responsibilities of Certi-fication Bodies (CB), Notified Bodies (NB), and other Regula-tors and/or Reimbursement Agencies, hereafter: Competent Authorities (CAs). - Knowing how to address CAs, including communication and interaction - Awareness of the importance of a quality management system (QMS) and knowing different systems, including, but not limited to ISO 13485:2016, GMP, GLP, GCP
Content
The journey of regulatory thinking - from medical devices (MDs), to in vitro diagnostics (IVDs), to software as a medical device (SaMD), to medicines and advanced therapeutic medicinal products (ATMPs): Commonalities, differences and the search for the lowest common denominator in terms of: - Regulations/Directives/Laws/Guidelines - Interaction with the regulatory authorities - The principles of safety/efficacy/performance/transparency - The requirements for the implementation of a QMS
General Information
- Language
- English
- Levels
- WBZ , NDS
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise | Regulatory Thinking | No time listed | 55 h semesterly |