Program Overview
This intensive program equips participants with a comprehensive understanding of performance evaluation and clinical evidence requirements for in-vitro diagnostics (IVDs). Delivered by an industry expert with 25+ years of experience, the course explores regulatory frameworks, key performance dimensions (scientific validity, analytical, and clinical performance), and practical case examples from global submissions. Through interactive simulations, group exercises, and real-world case studies, participants learn how to design effective evaluation plans, compile performance evaluation reports, and align evidence generation with regulatory expectations, ultimately reducing approval risks and accelerating market access.
Features
- Interpret global regulatory requirements (EU IVDR, US FDA, WHO) for IVD performance evaluation.
- Differentiate between scientific validity, analytical performance, and clinical performance.
- Apply structured frameworks to build Performance Evaluation Plans (PEP) and Reports (PER).
- Integrate real-world evidence and post-market surveillance into clinical evidence packages.
Target audiences
- Regulatory Affairs Professionals
- Product Development and R&D Professionals
- Quality Assurance Professionals
- Clinical Research Professionals
Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- 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
Instructor
