The implementation of the In Vitro Diagnostic Regulation (IVDR) has significantly transformed the regulatory and operational landscape for laboratories developing and using Laboratory Developed Tests (LDTs). In particular, laboratories working with custom assays must now demonstrate robust design control, clearly defined performance characteristics and comprehensive technical documentation aligned with IVDR expectations. This webinar provides a practical and end-to-end overview of the IVDR compliance process for LDTs, illustrated through a case study focused on implementing IVDR requirements for custom LDT assays.
Attendees will gain a structured understanding of how to approach method development and optimization, with an emphasis on identifying critical assay steps, understanding sources of variability and applying effective risk mitigation strategies early in the development lifecycle. The session will explore how IVDR design control principles can be applied in practice to systematically qualify reagents, consumables and assay parameters, ensuring assay robustness, reproducibility and regulatory readiness.
The webinar will also address method validation and implementation under IVDR, outlining best practices for defining performance evaluation strategies and acceptance criteria. Key validation parameters, including precision, sensitivity, specificity and threshold determination, will be discussed in the context of IVDR regulatory expectations. Through a practical case study, participants will learn to translate validation data into compliant and defensible documentation.
In addition, the session will clarify IVDR requirements for proficiency testing and provide practical guidance on preparing an IVDR-compliant technical dossier to support CE marking of custom LDT assays. Common challenges, pitfalls and lessons learned from real implementation experience will be shared to help laboratories reduce regulatory risk and avoid rework.
Register for this webinar to learn how IVDR compliance for custom LDT assays supports method validation, technical documentation and CE marking.
Speakers
Lorella Di Donato, Chief Laboratory & Operations Officer, Cerba Research
Lorella Di Donato has over 30 years of experience in the clinical research industry. Throughout her career, she has developed deep expertise across a broad range of therapeutic areas and platforms, with a strong focus on laboratory operations, assay development and validation for both small molecules and biologics.
At Cerba Research, Lorella is responsible for laboratory and operations services, ensuring harmonization, consistency and global standards across the organization. Her expertise spans advanced analytical technologies, including mass spectrometry, flow cytometry, immunoassays, ELISpot, Olink and other biomarker platforms.
Lorella joined Cerba Research in May 2024 as Senior Vice President and Co-CEO of the Canada site (formerly legacy Cirion), where she provides strategic and operational leadership. Prior to joining Cerba Research, Lorella held several senior leadership roles at CellCarta, including Chief Operating Officer and Chief Scientific Officer, where she supported growth and scientific excellence across global operations. She holds a PhD in Biochemistry from the University of Montreal.
Message Presenter
Martin Roberge, PhD, Director, Development & Innovation, Cerba Research
Martin Roberge has over 26 years of experience in the life science industry. Throughout his career in biotech and contract research organizations, Martin developed extensive expertise in protein engineering, bioanalysis and drug development. At Cerba Research, Martin provides leadership and scientific expertise for method development and GLP/GCLP validation projects for large molecule drug products in support of preclinical and clinical studies. Methods include immunogenicity assays (ADA, NAb), PK assays, biomarkers, qPCR and others.
He earned his PhD in Biology from the University of Sherbrooke in Québec, Canada. His experience includes working at a start-up CRO in Montréal, a Scientist II position at Genencor International Inc. and completing a postdoctoral fellowship at Genentech Inc. in the Protein Engineering department.
Message Presenter
Marie-Laure Delalande, Head of IVD Operations, Cerba Research
Marie-Laure Delalande is Head of IVD Operations at Cerba Research, a full-service partner for IVD manufacturers, supporting the entire product lifecycle from biospecimen procurement to performance evaluation for CE marking and FDA approval.
With over a decade of experience in the IVD industry, she previously held R&D and laboratory leadership positions at Stago, specializing in Hemostasis and Thrombosis, where she oversaw performance evaluation of new analyzers for CE marking and FDA approval. She began her career as a Systems Engineer at CERN in Geneva.
Marie-Laure holds a Master’s degree in Mechanical Engineering from the University of Grenoble.
Message PresenterWho Should Attend?
This webinar will appeal to the following senior professionals from pharma and biotech organizations, plus CROs, with a focus on clinical trials and diagnostics:
- Clinical Development teams
- Clinical Operations teams
- Biomarker/Translational Science teams
- Precision Medicine Leads
- Regulatory Affairs Directors
- Companion Diagnostics Leads
- External Vendor Managers
- Quality Assurance
What You Will Learn
Attendees will gain insight into:
- Method development and optimization of custom LDT assays, including critical steps identification and risk mitigation
- Design control: systematic qualification of reagents, consumables and assay parameters to ensure method robustness
- Method validation and implementation: performance assessments (precision, sensitivity, specificity and threshold determination) against predefined acceptance criteria
- Proficiency testing and IVDR-compliant technical dossier preparation for CE marking
Xtalks Partner
Cerba
Cerba Research, a strategic provider of diagnostic solutions, supports drug development by leveraging patient data and scientific insight to optimize R&D and commercialization globally. Providing early phase research, clinical development through central laboratory and diagnostic testing, assay and biomarker development and validation — through our global network of specialty laboratories. We partner with government agencies, non-government organizations, as well as pharma and biotech organizations to change the shape of clinical development and advance healthcare. Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.
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