Upcoming Events

Designed for senior regulatory leaders, this program sharpens high-level communication, strategic decision-making, and risk management skills. It equips participants with proven techniques to align stakeholders, foster inclusion, and navigate complex, high-stakes environments with clarity and confidence.

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.

An inside look at technical standardization: from contributing to UNI/PdR 140:2023 to applying standards in everyday professional practice. Learn how experts can help shape the standards that support their work

This two-day interactive workshop is designed to equip regulatory and quality professionals with the essential knowledge to guide their organizations in navigating global Software as a Medical Device expectation.

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.

Driving Engagement and Exploring Innovation for Combination Products

Purpose of the Target Product Profile (TPP) and Target Product Label (TPL) Overview of Competitive Labeling Strategy for Clinical Development and Marketing Optimal Timeline for Development of TPP and TPL How the TPL Shapes the Phase 3 protocol Use of Labeling Intelligence in the TPL process

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.

Regulations change, customer expectations evolve, and businesses grow. Is your quality management system built to keep up? This webcast will explain how a global medical device contract manufacturer modernized its quality system to support multiple sites, diverse customer requirements in an increasingly complex regulatory landscape. Participants will get a reality check on today's quality challenges and what organizations should look for in an eQMS to support compliance, scalability, and long-term regulatory readiness.

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

The UBC Academy of Translational Medicine and the Western Canada Regulatory Affairs Professional Society present: “AI in Regulatory Affairs: Game Changer or Compliance Risk?” A live debate

Vrijdag 27 November wordt duurzaamheid en herverwerken van medische hulpmiddelen vanuit diverse punten bekeken.

The Canadian Association of Professionals in Regulatory Affairs (CAPRA) hosts its premier annual symposium

This interactive four-hour workshop will teach you how PRRCs function at organizations small and large, internal or outsourced, manufacturer or authorized representative, and working with medical devices or IVDs.

This two-hour interactive workshop explores how AI helps regulatory teams spot emerging trends earlier, track policy shifts faster and turn regulatory intelligence into strategic action.

Discover how biomarkers are used across the clinical development pathway and what happens when biomarker strategy meets the European regulatory landscape. This interactive workshop combines essential learning on biomarker types, applications and development pathways with practical guidance on CTR and IVDR requirements. Through real world examples, case studies and group exercises, participants will learn how biomarker decisions affect trial design, regulatory strategy, documentation and operational delivery.

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.

This three-day introductory workshop provides a practical foundation for understanding the regulatory landscape governing combination products in the US, European Union, and key global markets.

Join us for an evening of holiday cheer, connection, and conversation! The RAPS Colorado Chapter invites all regulatory professionals to our winter holiday networking happy hour at Bohemian Biergarten on Boulder’s Pearl Street. Whether you’re a seasoned regulatory expert or just starting your career, this is a great chance to close out the year with peers, swap insights, and celebrate our local regulatory community. Dig out your ugliest holiday sweater! Tacky, festive, over-the-top knitwear is strongly encouraged (but not required). It’s an easy conversation starter, and we’d love to see what you’ve got. This relaxed gathering is the perfect opportunity to meet fellow regulatory professionals, learn about upcoming RAPS Colorado Chapter activities, and enjoy the festive biergarten atmosphere in the heart of downtown Boulder. Bring a colleague! RA-adjacent professionals and anyone curious about a career in regulatory affairs are welcome. There’s no cost to attend; just register so we know to expect you. We look forward to celebrating the season with you! Date & Time Wednesday, December 9, 2026 4:30 to 7:00 PM Location Bohemian Biergarten 2017 13th St Boulder, CO 80302

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

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.

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