Upcoming Events

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.

AI hallucinations are the central unsolved problem for deploying language models in regulated industries: medical devices, clinical decision support, and drug development. This session presents the hypothesis that standard LLMs hallucinate because of an architectural gap. They hold no internal state they must remain consistent with, so output is statistical pattern matching rather than a constrained read against a model of self, history, or relationship. The session walks through an architecturally-governed AI substrate whose hormone state, scar memory, and trust lattice function as inspectable reasoning artifacts, and examines the regulatory implications for ALCOA+ audit trails, Predetermined Change Control Plans, and the FDA De Novo pathway for Class II AI-enabled Software as a Medical Device. It closes by opening a broader question this room is uniquely positioned to answer: what kind of validation should AI require before we trust it with regulated decisions?

A deep dive into European Medical Device Regulation (MDR)

The RAPS NC Local Networking Group presents an in-person FDA ASCA Program session focused on the appropriate use of standards, conformity assessment, and practical strategies for premarket submissions. Presented by RAPS in partnership with and sponsored by UL Solutions, the event will feature FDA speakers and provide regulatory, quality, testing, and product development professionals with practical insights into how ASCA works and how it can support more predictable device submissions.

Join SGS and the RAPS Boston Chapter for a high-impact, one-day symposium dedicated to the critical risks and regulatory challenges facing pharmaceutical and medical device supply chains in 2026 and beyond. The program features insightful presentations, expert panel discussions, and practical takeaways designed for regulatory affairs, quality, compliance, and supply chain professionals. The agenda highlights include morning and afternoon sessions, networking lunch, and a closing reception/happy hour from 4:20 – 6:00 PM. Hosted by Scott Blood and Shona D’Souza (RAPS Boston Chapter), this is a must-attend event for professionals seeking actionable strategies to strengthen supply chain resilience and ensure compliance in a complex regulatory landscape.

Join a RAPS San Francisco networking and recruitment series across multiple in-person events. Meet regulatory professionals, connect with chapter leaders, and learn about ambassador and leadership roles. Build your network and support the local regulatory community.

This is a RAPS-SF Executives event exclusive for VP and above. This facilitated roundtable provides an intimate, interactive environment for senior professionals to unpack monumental changes at the FDA, share strategic playbooks, and candidly discuss what the "new normal" at the FDA means for our industry.

Preparing a successful 510(k) requires more than completing a template—it requires a clear regulatory strategy, thoughtful planning, cross-functional coordination, and a thorough understanding of FDA expectations. Join regulatory consultant Nancy Sauer for a practical discussion of 510(k) submission best practices, common pitfalls, and lessons learned from working with FDA's eSTAR submission platform.

Join the NJ and Philadelphia chapters as we host FDA and Intertek speakers discussing FDA’s Accreditation Scheme for Conformity Assessment (ASCA) and how it streamlines premarket review by elevating the quality and consistency of testing laboratories, enabling reviewers to assess complex areas like biocompatibility and EMC in minutes rather than hours. This session explains how ASCA reduces deficiencies, protects test data integrity, and demonstrates through real case studies how submissions once stalled for months can move forward in weeks.

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.

Join RAPS Ontario for our Summer Social, featuring an exciting Speed Networking session and inspiring career conversations. Connect with fellow Regulatory Affairs professionals, students, and industry leaders. Hear diverse career stories, expand your network, and enjoy light snacks and refreshments in a relaxed and welcoming environment.

This webinar explores how Quality Management Systems (QMS) evolve across the organizational lifecycle - from lean startup environments to complex global enterprises. Attendees will gain practical insights on balancing speed and compliance, designing scalable processes, while navigating resources as well as regulatory and cultural challenges at different growth stages. Learn how to navigate QMS that supports innovation while ensuring Global Regulatory Readiness in varying company environments.

Join Health Tech Pathways, Scarlet, and RAPS Nordic LNG for a practical, no-fluff introduction to navigating EU MDR for medical software and AI.

A practical session on biological evaluation of medical devices: ISO 10993, US FDA & EU MDR expectations, and chemical characterization. Hosted by TUV SUD with Medtronic.

Join RAPS Southern California, IPM, and Intertek for Connected Health at a Crossroads: Devices, Data, and Convergence, an evening of networking and thought-provoking discussion with MedTech leaders

The submission process for Master Notified Body Opinions concerning drug-device combinations as required by EU MDR 2017/745.

Educational and Networking event for students in Southern California to explore our professional support in the regulatory and quality community.

Now in its 10th edition, the Summit brings together manufacturers, Authorised Representatives, Notified Bodies, regulators, legal experts, policy stakeholders, and industry leaders to discuss the practical realities of MDR and IVDR implementation.

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.

In this webcast, you will learn how to secure your role as an EU compliance professional. Discover the essential steps to earning the RAPS Regulatory Compliance Certification.

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

This webcast will help regulatory teams sequence ePI, eCTD v4.0, and structure CMC requirements by building one governed, reusable content foundation across global submission timelines.

This webinar will walk you through how to apply the FDA's CSA's risk-based principles to AI, and what that looks like in practice, using a validated requirement conflict detection AI agent as a real-world example.

A practical, two-day workshop that decodes the full ADC development journey — from CMC and analytical control through non-clinical, clinical and expedited pathways to global submissions and market access — using recently approved antibody-drug conjugates as working case studies.

Join a powerful community of healthcare leaders, innovators, and policymakers driving change across the continent. Whether you’re attending, speaking, or sponsoring, AfriSummit is your platform to connect, contribute, and lead.