Upcoming Events

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 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.

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.

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.

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.

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.