RAPS Workshop: Performance Studies Under IVDR

RAPS's Performance Studies Under IVDR workshop runs virtually for two hours — 20 October 2026, 9–11 a.m. EDT — walking clinical affairs, regulatory and quality professionals through EU IVDR 2017/746 performance study requirements for IVDs and companion diagnostics, with particular emphasis on pharma and biotech teams moving into diagnostics or partnering with an IVD manufacturer.

Dates and format

• Date: 20 October 2026, 9–11 a.m. EDT
• Format: virtual, live online session
• Organizer: Regulatory Affairs Professionals Society (RAPS)
• Fee: not stated in the sources available for this listing — confirm on RAPS's own page

What it covers

The session gives clinical affairs, regulatory and quality professionals a focused overview of EU IVDR 2017/746 performance study requirements for in vitro diagnostics and companion diagnostics. RAPS pitches it specifically at pharma and biotech teams moving into diagnostics for the first time or partnering with an IVD manufacturer — the audience most likely to be building this fluency from a standing start rather than refreshing existing IVDR practice.

Who should attend

Clinical affairs, regulatory and quality leads whose companion-diagnostic or IVD program now has to satisfy EU IVDR performance study requirements, especially teams whose primary experience is drug development rather than devices. RAPS's own EU Medical Device Regulation 2017/745 workshop covers the parallel device-side regulation, and its PRRC Perspectives workshop tackles MDR/IVDR compliance roles more broadly.