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Labquality Days is Northern Europe’s leading congress dedicated to quality in laboratory medicine.

Learn how the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.

This interactive course gives clinical affairs, regulatory and quality professionals a focused overview of EU IVDR 2017/746 performance study requirements for IVDs and companion diagnostics, with an emphasis on pharma/biotech teams moving into diagnostics or partnering with IVD manufacturers. You’ll explore performance study design and conduct, QMS alignment with ISO13485 and IVDR, bridging analytical to clinical performance, vendor and diagnostic endpoint selection, and dual EU regulatory pathways, and leave with a practical framework for performance study plans to work with CROs or diagnostic sponsors that satisfy both notified bodies.

Please join us for this informal event meant to connect our chapter members to each other and build our professional networks.

This three-day introductory workshop provides a practical foundation for understanding the regulatory landscape governing combination products in the US, European Union, and key global markets.

Sponsored by Edge One Medical. Regulatory strategy is most effective when it shapes development decisions early—not when it is applied only as a submission-readiness activity. This presentation introduces the regulatory moat: an integrated framework that protects drug, device, and combination-product programs from internal risks such as fragmented decisions, unclear ownership, incomplete evidence plans, supplier-interface gaps, and misaligned timelines.

Discover how biomarkers are used across the clinical development pathway and what happens when biomarker strategy meets the European regulatory landscape. This interactive workshop combines essential learning on biomarker types, applications and development pathways with practical guidance on CTR and IVDR requirements. Through real world examples, case studies and group exercises, participants will learn how biomarker decisions affect trial design, regulatory strategy, documentation and operational delivery.

This two-hour interactive workshop explores how AI helps regulatory teams spot emerging trends earlier, track policy shifts faster and turn regulatory intelligence into strategic action.

The Canadian Association of Professionals in Regulatory Affairs (CAPRA) hosts its premier annual symposium