Mastering Clinical Performance Studies under IVDR
Learn how to design and deliver successful clinical performance studies under IVDR. Explore strategic, regulatory, and operational aspects with expert guidance.
The regulatory landscape for in vitro diagnostic (IVD) devices is constantly evolving, making it critical to provide evidence of your device’s clinical performance. This webinar will delve into the strategic, regulatory, and operational aspects of conducting successful clinical performance studies.
With input from IVD experts, we’ll explore what it takes to create a robust and compliant study design, effectively source samples and sites, and meet the unique challenges posed by self-testing and near-patient testing devices. Additionally, our panel will discuss the requirements outlined in Annex XIV of the IVDR and provide tips on managing performance study applications across EU Member States.
Whether you’re preparing for a new submission or looking to refine your current approach, this session is designed to provide actionable guidance to help you succeed.
What you'll learn
- Collect reliable clinical data
- Align with regulatory requirements
- Design effective study plans
- Source samples and select sites
- Self-testing and near-patient testing considerations
- Common assessment gaps from notified bodies
- Key points of Annex XIV
- Manage applications across EU Member States
Learn from the best
Speakers
Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.
Annelies Rotthier
Scientific Affairs and IVD Clinical Evidence Manager
Annelies Rotthier is a senior IVD consultant. After her Ph.D. in Molecular Genetics at the VIB Institute in Antwerp, she pursued her career in the field of molecular genetics as R&D manager in the spin-off company Multiplicom and later as Director Product Development at Agilent Technologies, a major player in Next Generation Sequencing IVD applications. She brings her experience to support companies with product development in compliance with IVD Regulation and with the transition to the new IVD Regulation. Risk management activities in accordance with ISO14971 is one of her main expertise.
Kirsten Van Garsse
Director Representative Service & Manager IVD - Regulatory Affairs
Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has amassed extensive experience in the In Vitro Diagnostic Medical Device Industry. She joined Qarad, now part of the QbD Group, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017. In her role as Director of Authorized Representative Services & Manager of IVD Regulatory Affairs, Kirsten applies her wealth of experience to Regulatory Affairs projects, adeptly translating regulations into compliant business processes and applications. Additionally, she oversees the various Representation Services offered by Qarad, ensuring clients receive expert support in navigating regulatory requirements.