Dive into the realm of assay validation in the new advanced genomics course provided by Jan Hellemans, Guidance for the Validation of qPCR and ddPCR Assays in Regulated Environments. Designed for research scientists in the clinical realm, this concise and comprehensive session aims to empower attendees in approaches to validating qPCR and ddPCR assays effectively for robust clinical research. This live webinar provides an overview of the processes involved in validation of assays from research use only (RUO) to in vitro diagnostic (IVD) status, specifically focusing on quantitative PCR (qPCR) and Droplet Digital™ PCR (ddPCR) formats. Explore essential validation parameters, regulatory considerations, and real‑world case studies to expand your understanding of assay development in clinical research. These actionable insights and strategies are designed to help attendees navigate the challenges of ensuring their assays can meet rigorous standards.
Join us to learn about:
- Validation approaches: learn effective methods to validate qPCR and ddPCR assays in research and clinical settings
- RUO to IVD transition: understand the process and regulations for transitioning assays
- Case studies and strategies: gain insights and strategies for navigating assay challenges in regulated settings
Get a certificate for attending
A certificate of completion will be awarded to those who attend the course.
Jan Hellemans,
COO of pxlence
Dr. Jan Helleman's education and industrial career have consistently focused on qPCR and assay validation. During his Master's degree in biotechnology and doctorate in Medical Genetics, he gained an understanding of the correct procedures for performing qPCR. Subsequently, at Biogazelle, he developed and validated assays for research purposes. Later, at CellCarta, he shifted his focus to clinical research assays, including clinical diagnostic assays under IVD‑R design control. In his current role as COO at pxlence, he oversees product development for both qPCR and ddPCR.