Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
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- Foundations of Performance Evaluation in IVDs5
- 1.1Global regulatory landscape: EU IVDR 2017/746, FDA guidance, WHO prequalification
- 1.2Performance Evaluation Plan (PEP) & Performance Evaluation Report (PER)
- 1.3Clinical Evidence Package (CEP)
- 1.4Scientific validity vs Analytical performance vs Clinical performance
- 1.5Lifecycle approach – from design input to post-market
- Navigating Regulatory Expectations4
- 2.1Case examples: EU notified body reviews under IVDR vs legacy IVDD
- 2.2Common pitfalls: Insufficient clinical evidence, weak scientific validity claims
- 2.3Regional nuances: US (510(k)/De Novo), EU IVDR, India CDSCO, China NMPA
- 2.4Evidence requirements for rapid tests, molecular diagnostics, companion diagnostics
- Real-Life Case Sharing – Clinical Evidence in Practice5
- 3.1Expert walkthrough: Building a Performance Evaluation Report (PER)
- 3.2Examples of successful clinical performance studies in hematology, infectious disease, oncology diagnostics
- 3.3Real-world evidence integration: PMS data, registries, biobanks
- 3.4Post-market clinical follow-up (PMCF) for high-risk IVDs
- 3.5Case Study: Companion diagnostic for oncology – linking biomarkers to therapeutic outcomes
- Interactive Simulation & Hands-On Exercise4
- Wrap-Up & Key Takeaways2
Linking scientific validity + analytical + clinical performance is critical for compliance
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