Upcoming Events

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.

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.

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.

Assessment of abuse liability is a critical yet often misunderstood component of drug development for products with potential central nervous system activity. Drawing on over two decades of experience collaborating with FDA's Controlled Substance Staff (CSS) through the Cross Company Abuse Liability Council (CCALC), this session will provide insights into the nonclinical and clinical considerations that support a robust abuse liability assessment strategy. Attendees will gain a clearer understanding of regulatory expectations, common challenges, and key sponsor responsibilities that can impact submission success.

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.

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