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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.

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

Driving Engagement and Exploring Innovation for Combination Products

Join the NJ NY RAPS Chapter as we host a virtual session on how agencies have responded to Humanized Mouse (huMouse) justifications in practice, and how to position these models across development stages. The goal is to help attendees make better-informed decisions about when huMouse models strengthen a regulatory submission — and when they don't.

Gain confidence in implementing the EU MDR! Receive useful advice on updating your quality system, overseeing economic operators, addressing labeling, and handling technical documentation.

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

Health Canada Medical Device Single Audit Program (MDSAP) Advancements

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.