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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.

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

This interactive four-hour workshop will teach you how PRRCs function at organizations small and large, internal or outsourced, manufacturer or authorized representative, and working with medical devices or IVDs.

Standards drive consistency and should reduce the uncertainty in product development and life cycle management. Join this session to hear from a panel of standards developers who will provide their insights and perspectives on how engagement with standards development can be a tool for both regulatory intelligence and ongoing compliance.

Regulations change, customer expectations evolve, and businesses grow. Is your quality management system built to keep up? This webcast will explain how a global medical device contract manufacturer modernized its quality system to support multiple sites, diverse customer requirements in an increasingly complex regulatory landscape. Participants will get a reality check on today's quality challenges and what organizations should look for in an eQMS to support compliance, scalability, and long-term regulatory readiness.