VVZ API is not affiliated with ETH Zurich. Data might be outdated or incorrect. Please view the official ETHZ Vorlesungsverzeichnis for binding information.
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
- NDS , WBZ
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise |
Regulatory Thinking
Does not take place this semester.
|
No time listed | 55 h semesterly |