Past Events

This expert-led workshop will show you how to turn regulatory alerts into actionable intelligence using trusted sources, practical prioritization, and clear internal communication.

Join the NJ 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.

Sponsored by SGS. Hear FDA speakers on the ASCA Program and QMSR inspections, then work through two hands-on ISO 14971 risk workshops.

RAPS Houston LNG presents the FDA ASCA Program Roadshow Panel Event, featuring Biotex, Inc at the TMC Innovation Factory. This panel brings together an FDA representative and Wade Munsch of Biotex, Inc — the only Houston-based lab currently accredited under the Accreditation Scheme for Conformity Assessment (ASCA) — to explore how ASCA can streamline premarket submissions and improve regulatory efficiency. Ideal for regulatory professionals, quality engineers, lab managers, and life science innovators across the region.

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

Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologics. Emphasis on requirements in US, Europe, and other regions.

Building on the momentum of the inaugural “From Classroom to Career” panel held in May 2026, the RAPS NC Local Networking Group returns to continue the conversation on clinical research and regulatory affairs workforce development in North Carolina and beyond. This second installment brings together industry leaders, academic faculty, and emerging professionals to revisit the state of regulatory and clinical research education: what progress has been made since the spring discussion, where gaps still persist, and what new curricular innovations are shaping the pipeline of talent entering the field. Panelists will examine how academic programs are adapting to industry demand, the role of mentorship and experiential learning in preparing students for regulatory careers, and strategies for strengthening the connection between classroom instruction and real-world practice. This event is designed for clinical research professionals, regulatory affairs practitioners, academic faculty, students, and anyone invested in shaping the educational infrastructure that supports these fields.

Join us at UCI for an in-person evening event for students. Attendees will learn how graduate training connects to regulatory affairs careers in healthcare, hear from senior regulatory leaders, and gain practical advice on positioning their skills for hiring managers.

Learn how AI-enabled CER workflows can help regulatory teams improve efficiency, traceability, and MDR compliance while strengthening Notified Body readiness and preserving expert oversight.