Upcoming Events

Health Canada Medical Device Single Audit Program (MDSAP) Advancements

Join us for a networking and recruitment series across multiple in-person events. Meet regulatory professionals, connect with chapter leaders, and learn about ambassador and leadership roles.

Join RAPS Philadelphia for a cross-functional look at leveraging business and legal topics to supercharge your regulatory intelligence, drive product development insight, and communicate value effectively across your key stakeholders. In a program sure to be insightful for regulatory and legal professionals alike, an expert group of panelists will discuss strategies and practical takeaways to bring back to your business.

Build practical AI literacy skills for regulatory affairs through hands-on exercises and group discussions. Learn where AI can add value, understand its risks, and apply it responsibly across the regulatory lifecycle.

Explore responsible AI governance in GxP-regulated environments, covering risk, validation, data integrity, oversight, and how the EU AI Act and ISO/IEC 42001 align with existing quality frameworks.

Join SGS & RAPS for a dynamic full-day event focused on advancing medical technology and providing greater protection for patients, featuring multiple FDA speakers and medical device industry experts.

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.

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.

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.

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

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.

SGS is excited to bring to the GTA a comprehensive full-day symposium focused on the medical device industry. In partnership with the RAPS Ontario Chapter, the leading association for regulatory professionals, we will focus on navigating the latest quality and regulatory challenges in the Medtech industry, including AI in Medical Device, the latest developments in MDR, a guide to MDSAP and more. Join us for this exciting conference.

Explore FDA standards, ASCA, QMSR, ISO 13485, MDSAP, quality systems, manufacturing controls, and inspection readiness across medical devices, drugs, and biologics. Hear from FDA & industry experts

Navigating biological evaluation requirements can be complex and resource-intensive without a clear, forward-looking strategy grounded in current regulations. This session will provide an in-depth overview of the latest updates to ISO 10993-1:2025 and upcoming technical specifications designed to help manufacturers and assessors effectively implement these new expectations. Attendees will gain insight into how global regulatory authorities are recognizing and aligning with these changes, as well as the risk assessment and management principles driving key revisions. Finally, the session will outline strategic planning practices that can be applied early in the product development process to streamline biological evaluation activities, minimize delays, and ensure full compliance with ISO 10993-1:2025.

Explore the dynamics at FDA and why neither “naive harmony” nor inevitable conflict are good approaches to interactions with FDA. Learn effective techniques for strategic preparation and communication to work with FDA to avoid escalation and when needed how to escalate matters within FDA.

This is the kickoff meeting for RAPS Japan LNG. We will introduce RAPS Japan LNG, which was launched in September, and RAPS's activities, and discuss together the future vision and activities of RAPS Japan LNG.

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.

Practical case studies and regulatory insights with a special focus on the Belgian context.

Sponsored by Edge One Medical. Regulatory strategy is most effective when it shapes development decisions early—not when it is applied only as a submission-readiness activity. This presentation introduces the regulatory moat: an integrated framework that protects drug, device, and combination-product programs from internal risks such as fragmented decisions, unclear ownership, incomplete evidence plans, supplier-interface gaps, and misaligned timelines.

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