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

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

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.

With dedicated programme streams for human medicines (pharmaceuticals), medical devices, IVDs and veterinary medicines, the Symposium is the must-attend event in the regulatory affairs calendar.

This intensive 16-hour course, delivered across 4 half days, will give you an excellent grounding in the EU requirements for clinical evaluation.

Where regulatory professionals come together to make crucial connections, share expert insights, and discover the latest innovations.

Join this free webcast to find out whether RAC credential is right for you and how to get started. Discover how earning this globally recognized certification can boost your earning potential and your regulatory career.

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

This RAPS education webinar is designed to support students and early-career professionals seeking to better understand career opportunities within regulatory affairs and adjacent fields.

Is the zero-experience RAPS FRA credential right for you? It's the ideal way for early-career or transitioning professionals to prove foundational RA knowledge to employers and to jump-start their careers.