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Abstract
Exploring SaMD, MD, IVD, ATMPs, and Pharma regulations, we contrast their approval requirements and PMS strategies, focus-ing on safety, performance, and biological / chemical complexity. We look at reimbursement issues and link them to regulatory ap-proval and market access strategies, including economic aspects of product lifecycle management.
Objective
Principle of Regulatory Thinking • Apply the principle of regulatory thinking to navigate the healthtech product approval process. • Synthesize commonalities and differences in regulatory requirements across product types. Approval Processes • Outline the essential steps for pre-market approval, including clinical evaluation and testing. • Formulate strategies for effective regulatory submissions and agency interactions. Post-Market Surveillance (PMS) • Develop a framework for ongoing monitoring and reporting of product safety and effectiveness. • Prepare for adverse event reporting, recalls, and post-market clinical follow-up. Reimbursement Strategies • Link reimbursement strategies to regulatory approval and market access considerations. • Compare pricing and reimbursement models, understanding their influence on product success.
Content
Overview of Regulatory Frameworks for Healthtech Products • SaMD, MD, and IVD: Focus on safety and performance • ATMPs: Additional considerations for biological complexity • Pharmaceuticals: Distinct pathways based on chemical composition Principle of RegulatoryThinking • Commonalities in regulatory requirements across product types • Differences in approval processes for SaMD, MD, IVD, ATMPs vs. Pharmaceuticals Approval Processes • Regulatory submissions and interactions with agencies Post-Market Surveillance (PMS) • Reporting for ongoing safety and effectiveness • Adverse event reporting and product recalls • Post-market clinical follow-up and real-world evidence collection Reimbursement Strategies • Linking reimbursement to regulatory approval • Health economics and market access considerations • Pricing and reimbursement models for healthtech products Regulatory Compliance and Lifecycle Management • Maintaining compliance in a changing regulatory landscape • Managing product variations and updates • Role of quality management systems in regulatory compli-ance
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 |
Approval Post Market Activities
Does not take place this semester.
|
No time listed | 25 h semesterly |